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Revisiones-Clínica-Epidemiología, Higiene & Prevención *** Reviews-Clinical-Epidemiology, Hygiene & Prevention

 

AGENTES INMUNOSUPRESORES *** IMMUNOSUPPRESSIVE COMPOUNDS

(Conceptos / Keywords: Immunosuppressive comp; Muromonab-cd3; Sirolimus; Tacrolimus; Cyclosporine; Mycophenolic acid; Antilymphocyte serum; Immunosuppressive comp. used in oncology, etc).

 

Enero / January 2001 --- Marzo / March 2004

 

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Enlace / Link

 

[1]

TÍTULO / TITLE:  - Interleukin-2 receptor monoclonal antibodies in renal transplantation: meta-analysis of randomised trials.

REVISTA / JOURNAL:  - British Medical J (BMJ). Acceso gratuito al texto completo.

      ●● Enlace a la Editora de la Revista http://bmj.com/search.dtl 

      ●● Cita: British Medical J. (BMJ): <> 2003 Apr 12;326(7393):789.

      ●● Enlace al texto completo (gratuito o de pago) 1136/bmj.326.7393.789

AUTORES / AUTHORS:  - Adu D; Cockwell P; Ives NJ; Shaw J; Wheatley K

INSTITUCIÓN / INSTITUTION:  - Department of Nephrology, Queen Elizabeth Hospital, Birmingham, B15 2TH. dwomoa.adu@uhb.nhs.uk

RESUMEN / SUMMARY:  - OBJECTIVE: To study the effect of interleukin-2 receptor monoclonal antibodies on acute rejection episodes, graft loss, deaths, and rate of infection and malignancy in patients with renal transplants. DESIGN: Meta-analysis of published data. DATA SOURCES: Medline, Embase, and Cochrane library for years 1996-2003 plus search of medical editors’ trial amnesty and contact with manufacturers of the antibodies. SELECTION OF STUDIES: Randomised controlled trials comparing interleukin-2 receptor antibodies with placebo or no additional treatment in patients with renal transplants receiving ciclosporin based immunosuppression. RESULTS: Eight randomised controlled trials involving 1871 patients met the selection criteria (although only 1858 patients were analysed). Interleukin-2 receptor antibodies significantly reduced the risk of acute rejection (odds ratio 0.51, 95% confidence interval 0.42 to 0.63). There were no significant differences in the rate of graft loss (0.78, 0.58 to 1.04), mortality (0.75, 0.46 to 1.23), overall incidence of infections (0.97, 0.77 to 1.24), incidence of cytomegalovirus infections (0.81, 0.62 to 1.04), or risk of malignancies at one year (0.82, 0.39 to 1.70). The different antibodies had a similar sized effect on acute rejection (test for heterogeneity P=0.7): anti-Tac (0.37, 0.16 to 0.89), BT563 (0.37, 0.1 to 1.38), basiliximab (0.56, 0.44 to 0.72), and daclizumab (0.46, 0.32 to 0.67). The reduction in acute rejections was similar for all ciclosporin based immunosuppression regimens (test for heterogeneity P=1.0). CONCLUSIONS: Adding interleukin-2 receptor antibodies to ciclosporin based immunosuppression reduces episodes of acute rejection at six months by 49%. There is no evidence of an increased risk of infective complications. Longer follow up studies are needed to confirm whether interleukin-2 receptor antibodies improve long term graft and patient survival.

 

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[2]

TÍTULO / TITLE:  - Novel therapeutic molecular targets for prostate cancer: the mTOR signaling pathway and epidermal growth factor receptor.

REVISTA / JOURNAL:  - J Urol 2004 Feb;171(2 Pt 2):S41-3; discussion S44.

      ●● Enlace al texto completo (gratuito o de pago) 1097/01.ju.0000108100.53239.b7

AUTORES / AUTHORS:  - Tolcher AW

INSTITUCIÓN / INSTITUTION:  - Director Clinical Research, Institute for Drug Development Cancer Therapy and Research Center, San Antonio, Texas, USA.

RESUMEN / SUMMARY:  - PURPOSE: The scientific rationale and existing evidence for the use of novel molecular targets in the chemoprevention of cancer are reviewed, with special attention to prostate cancer. MATERIALS AND METHODS: A search for relevant literature on basic science and clinical trials was conducted using PubMed/MEDLINE. RESULTS: The emergence of molecularly targeted therapies for advanced malignancies creates an important opportunity to examine these agents for the chemoprevention of prostate cancer. Two critical targets in the proliferation and malignant transformation of normal cells, the PI3/Akt signal transduction pathway and the epidermal growth factor receptor, are currently the focus of several novel investigational therapies that are in late stage phase II and phase III studies. CONCLUSIONS: Research to date supports consideration of these novel molecular targets as future agents in the chemoprevention of prostate cancer.  N. Ref:: 28

 

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[3]

TÍTULO / TITLE:  - Drug-eluting stents in vascular intervention.

REVISTA / JOURNAL:  - Lancet 2003 Jan 18;361(9353):247-9.

AUTORES / AUTHORS:  - Fattori R; Piva T

INSTITUCIÓN / INSTITUTION:  - Department of Radiology, Cardiovascular Unit, University Hospital S Orsola, 40138, Bologna, Italy. ross@med.unibo.it

RESUMEN / SUMMARY:  - CONTEXT: Restenosis is the most important long-term limitation of stent implantation for coronary artery disease, occurring in 15-60% of patients. In-stent restenosis, a refractory coronary lesion resulting from neointimal hyperplasia, challenges both vascular biologist and interventional cardiologist. Various drugs and devices have been used tried to overcome restenosis but are not particularly successful. Over 1500000 percutaneous coronary interventions are done annually. Restenosis is not only important clinically but also for its impact on health-care costs. STARTING POINT: Growth and migration of vascular smooth-muscle cells result in neointimal proliferation after vascular injury and are the key mechanism of in-stent restenosis. The rationale of the most recent approaches to restenosis (eg, brachytherapy and immunosuppressive agents) arises from the similarity between tumour-cell growth and the benign tissue proliferation which characterises intimal hyperplasia. Several immunosuppressants have been tested for their potential to inhibit restenosis, with the novel strategy of administering the drug via a coated stent platform. Local drug delivery achieves higher tissue concentrations of drug without systemic effects, at a precise site and time. The first multicentre trial with stents coated with sirolimus was by Marie-Claude Morice and colleagues (N Engl J Med 2002; 346: 1773-80). In a trial of 238 patients, restenosis of 50% or more at 6 months was 0% and 27% with sirolimus or normal stents (p<0.001), respectively, after percutaneous revascularisation. Muzaffer Degertekin and colleagues (Circulation 2002; 106: 1610-13) present data on 2-year follow-up of 15 patients who had been implanted with the sirolimus stent in another study, and confirm persistent inhibition of restenosis and an absence of unexpected adverse events. WHERE NEXT? Local application of antiproliferative agents is a promising technique and research is developing. Other agents with potential benefits (eg, statins, local gene-therapy, adenovirus-mediated arterial gene-transfer, L-arginine, abciximab, angiopeptin, recombinant pegylated hirudin, and hiloprost) as well as improvements in polymer technology (biodegradable smart polymers, coatings for multiple-drug release) are under evaluation. The clinical impact of the elimination of restenosis may influence the approach to coronary artery disease, the future of cardiac surgery, and health-care economics in cardiology.  N. Ref:: 22

 

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[4]

TÍTULO / TITLE:  - Treatment of chronic granulomatous disease with myeloablative conditioning and an unmodified hemopoietic allograft: a survey of the European experience, 1985-2000.

REVISTA / JOURNAL:  - Blood. Acceso gratuito al texto completo a partir de 1 año de la fecha de publicación.

      ●● Enlace a la Editora de la Revista http://www.bloodjournal.org/ 

      ●● Cita: Blood: <> 2002 Dec 15;100(13):4344-50. Epub 2002 Aug 8.

      ●● Enlace al texto completo (gratuito o de pago) 1182/blood-2002-02-0583

AUTORES / AUTHORS:  - Seger RA; Gungor T; Belohradsky BH; Blanche S; Bordigoni P; Di Bartolomeo P; Flood T; Landais P; Muller S; Ozsahin H; Passwell JH; Porta F; Slavin S; Wulffraat N; Zintl F; Nagler A; Cant A; Fischer A

INSTITUCIÓN / INSTITUTION:  - European Group for Blood and Marrow Transplantation (EBMT) and the European Society for Immunodeficiencies (ESID), Division of Immunology/Hematology, University Children’s Hospital, Zurich, Switzerland. reinhard.seger@kispi.unizh.ch

RESUMEN / SUMMARY:  - Treatment of chronic granulomatous disease (CGD) with myeloablative bone marrow transplantation is considered risky. This study investigated complications and survival according to different risk factors present at transplantation. The outcomes of 27 transplantations for CGD, from 1985 to 2000, reported to the European Bone Marrow Transplant Registry for primary immunodeficiencies were assessed. Most transplant recipients were children (n = 25), received a myeloablative busulphan-based regimen (n = 23), and had unmodified marrow allografts (n = 23) from human leukocyte antigen (HLA)-identical sibling donors (n = 25). After myeloablative conditioning, all patients fully engrafted with donor cells; after myelosuppressive regimens, 2 of 4 patients fully engrafted. Severe (grade 3 or 4) graft-versus-host disease (GVHD) disease developed in 4 patients: 3 of 9 with pre-existing overt infection, 1 of 2 with acute inflammatory disease. Exacerbation of infection during aplasia was observed in 3 patients; inflammatory flare at the infection site during neutrophil engraftment in 2: all 5 patients belonged to the subgroup of 9 with pre-existing infection. Overall survival was 23 of 27, with 22 of 23 cured of CGD (median follow-up, 2 years). Survival was especially good in patients without infection at the moment of transplantation (18 of 18). Pre-existing infections and inflammatory lesions have cleared in all survivors (except in one with autologous reconstitution). Myeloablative conditioning followed by transplantation of unmodified hemopoietic stem cells, if performed at the first signs of a severe course of the disease, is a valid therapeutic option for children with CGD having an HLA-identical donor.  N. Ref:: 30

 

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[5]

TÍTULO / TITLE:  - Pregnancy outcome after cyclosporine therapy during pregnancy: a meta-analysis.

REVISTA / JOURNAL:  - Transplantation 2001 Apr 27;71(8):1051-5.

AUTORES / AUTHORS:  - Bar Oz B; Hackman R; Einarson T; Koren G

INSTITUCIÓN / INSTITUTION:  - The Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children, Toronto, Ontario, Canada.

RESUMEN / SUMMARY:  - BACKGROUND: Cyclosporine (CsA) therapy must often be continued during pregnancy to maintain maternal health in such conditions as organ transplantation and autoimmune disease. This meta-analysis was performed to determine whether CsA exposure during pregnancy is associated with an increased risk of congenital malformations, preterm delivery, or low birthweight. METHODS: Various health science databases were searched to identify relevant articles. Articles selected for inclusion in the study were required to be free of any apparent selection bias and report outcomes in at least 10 newborns exposed to CsA in utero, specifically commenting on the presence or absence of congenital malformations. Article selection and data extraction were performed by two independent reviewers, with adjudication in cases of disagreement. To assess risks of CsA exposure, a summary odds ratio was calculated. Prevalence of malformations was calculated as a rate for all cyclosporine-exposed live births and for the subgroups identified. Ninety-five percent confidence intervals were constructed for both the odds ratio and prevalence rates. RESULTS: Fifteen studies (6 with control groups of transplant without use of cyclosporine; total patients: 410) met the inclusion criteria for major malformations, 10 for preterm delivery (4 with control groups; total patients: 379) and 5 for low birth weight (1 with control groups; total number of patients: 314). The calculated odds ratio of 3.83 for malformations did not achieve statistical significance (CI 0.75-19.6). The overall prevalence of major malformations in the study population (4.1%) also did not vary substantially from that reported in the general population. OR for prematurity [1.52 (CI 1.00-2.32)] did not reach statistical significance although the overall prevalence rate was 56.3%. The OR for low birth weight [1.5 (CI 0.95-2.44 based on 1 study)]. CONCLUSIONS: CsA does not appear to be a major human teratogen. It may be associated with increased rates of prematurity. More research is needed to evaluate whether cyclosporine increases teratogenic risk.

 

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[6]

TÍTULO / TITLE:  - Posttransplantation diabetes: a systematic review of the literature.

REVISTA / JOURNAL:  - Diabetes Care. Acceso gratuito al texto completo a partir de 1 año de la fecha de publicación.

      ●● Enlace a la Editora de la Revista http://care.diabetesjournals.org/ 

      ●● Cita: Diabetes Care: <> 2002 Mar;25(3):583-92.

AUTORES / AUTHORS:  - Montori VM; Basu A; Erwin PJ; Velosa JA; Gabriel SE; Kudva YC

INSTITUCIÓN / INSTITUTION:  - Division of Endocrinology, Diabetes, Metabolism, Nutrition, and Internal Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.

RESUMEN / SUMMARY:  - OBJECTIVES: To systematically review the incidence of posttransplantation diabetes (PTD), risk factors for its development, prognostic implications, and optimal management. RESEARCH DESIGN AND METHODS: We searched databases (MEDLINE, EMBASE, the Cochrane Library, and others) from inception to September 2000, reviewed bibliographies in reports retrieved, contacted transplantation experts, and reviewed specialty journals. Two reviewers independently determined report inclusion (original studies, in all languages, of PTD in adults with no history of diabetes before transplantation), assessed study methods, and extracted data using a standardized form. Meta-regression was used to explain between-study differences in incidence. RESULTS: Nineteen studies with 3,611 patients were included. The 12-month cumulative incidence of PTD is lower (<10% in most studies) than it was 3 decades ago. The type of immunosuppression explained 74% of the variability in incidence (P = 0.0004). Risk factors were patient age, nonwhite ethnicity, glucocorticoid treatment for rejection, and immunosuppression with high-dose cyclosporine and tacrolimus. PTD was associated with decreased graft and patient survival in earlier studies; later studies showed improved outcomes. Randomized trials of treatment regimens have not been conducted. CONCLUSIONS: Physicians should consider modification of immunosuppressive regimens to decrease the risk of PTD in high-risk transplant recipients. Randomized trials are needed to evaluate the use of oral glucose-lowering agents in transplant recipients, paying particular attention to interactions with immunosuppressive drugs.  N. Ref:: 79

 

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[7]

TÍTULO / TITLE:  - Calcineurin inhibition and cardiac hypertrophy: a matter of balance.

REVISTA / JOURNAL:  - Proc Natl Acad Sci U S A. Acceso gratuito al texto completo a partir de los 6 meses de la fecha de publicación.

      ●● Enlace a la Editora de la Revista http://www.pnas.org/ 

      ●● Cita: Proc Natl Acad Sci USA (PNAS): <> 2001 Mar 13;98(6):2947-9.

      ●● Enlace al texto completo (gratuito o de pago) 1073/pnas.051033698

AUTORES / AUTHORS:  - Leinwand LA

INSTITUCIÓN / INSTITUTION:  - Department of Molecular, Cellular, and Developmental Biology, Porter Addition, Room A3B40, University of Colorado, Boulder, CO 80309-0347, USA. leinwand@stripe.colorado.edu  N. Ref:: 18

 

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[8]

TÍTULO / TITLE:  - Mycophenolate mofetil for the prevention and treatment of graft-versus-host disease following stem cell transplantation: preliminary findings.

REVISTA / JOURNAL:  - Bone Marrow Transplant 2001 Jun;27(12):1255-62.

AUTORES / AUTHORS:  - Vogelsang GB; Arai S

INSTITUCIÓN / INSTITUTION:  - Department of Oncology, Johns Hopkins Oncology Center, Baltimore, MD 21287-8943, USA.

RESUMEN / SUMMARY:  - The therapeutic benefits of allogeneic stem cell transplantation in patients with hematologic disorders are limited by the significant morbidity and mortality of graft-versus-host disease (GVHD). Current agents for the prevention and treatment of GVHD have limited efficacy and often result in toxic side-effects. Mycophenolate mofetil (MMF) is a new immunosuppressant with a selective mechanism of action. When employed following solid organ transplantation, MMF reduces the incidence and severity of acute rejection episodes. By selectively targeting activated lymphocytes, the active metabolite of MMF, mycophenolic acid (MPA), appears to augment the actions of standard immunosuppressant agents without adding overlapping toxicities. Studies of combination regimens that include MMF report that this agent permits a dose reduction of cyclosporine, tacrolimus, or corticosteroid, without increasing the incidence of acute rejection in solid organ transplants. Reports on the efficacy of MMF following stem cell transplantation in animal studies were mixed. However, the use of a non-myeloablative conditioning regimen with a post-graft immunosuppressive regimen of MMF and cyclosporine was able to sustain stable mixed chimeras in 60% to 80% of dogs who received hematopoietic grafts from DLA-identical littermates. MMF has demonstrated activity in preliminary clinical trials for GVHD prophylaxis, and treatment of acute or chronic GVHD. Larger clinical trials are warranted to determine the optimum dose and route of MMF administration for GVHD, as well as the comparative safety and efficacy of MMF-containing regimens.  N. Ref:: 36

 

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[9]

TÍTULO / TITLE:  - Prevention by dietary (n-6) polyunsaturated phosphatidylcholines of intrahepatic cholestasis induced by cyclosporine A in animals.

REVISTA / JOURNAL:  - Life Sci 2003 Jun 13;73(4):381-92.

AUTORES / AUTHORS:  - Chanussot F; Benkoel L

INSTITUCIÓN / INSTITUTION:  - INSERM U. 476, Faculte de Medecine, 27 bd Jean Moulin, 13385 Marseille cedex 05, France. Francoise.Chanussot@medecine.univ-mrs.fr

RESUMEN / SUMMARY:  - Previous findings showed that dietary (n-6) polyunsaturated phosphatidylcholines (vegetable lecithin) could efficiently prevent intrahepatic cholestasis induced by cyclosporine A in rats. Mechanistic studies showed that expressions in rat liver of Na(+), K(+)-ATPase, Ca(2+), Mg(2+)-ATPase and F-actin were both decreased by drug administration and both enhanced by (n-6) lecithin enriched diet. There is a possible direct effect of phosphatidylcholines, vectors of polyunsaturated fatty acids provided by the metabolism of the dietary lecithin, on the aforesaid hepatic parameters. Such modulations by drug and diet result in reversed modifications of membrane composition and fluidity. Final outcome is decreased and enhanced bile lipid secretion by cyclosporine and vegetable lecithin enriched diet respectively. Moreover, we advance the hypothesis of a bypass process including a separate and functional actin-independent way for the non micellar and phospholipid-dependent secretion of bile lipids. The relationships between the ATPases, the microfilament components such as F-actin and the different transporters still remain to be clarified. Furthermore, one can speculate on beneficial effects in humans of diets enriched in vegetable lecithins that might prevent cholestasis induced by cyclosporine A.  N. Ref:: 75

 

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[10]

TÍTULO / TITLE:  - A benefit-risk assessment of basiliximab in renal transplantation.

REVISTA / JOURNAL:  - Drug Saf. Acceso gratuito al texto completo.

      ●● Enlace a la Editora de la Revista http://www.csmwm.org/ 

      ●● Cita: Drug Safety: <> 2004;27(2):91-106.

AUTORES / AUTHORS:  - Boggi U; Danesi R; Vistoli F; Del Chiaro M; Signori S; Marchetti P; Del Tacca M; Mosca F

INSTITUCIÓN / INSTITUTION:  - Division of General Surgery and Transplants, Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy. uboggi@med.unipi.it

RESUMEN / SUMMARY:  - Interleukin-2 (IL-2) and its receptor (IL-2R) play a central role in T lymphocyte activation and immune response after transplantation. Research on the biology of IL-2R allowed the identification of key signal transduction pathways involved in the generation of proliferative and antiapoptotic signals in T cells. The alpha-chain of the IL-2R is a specific peptide against which monoclonal antibodies have been raised, with the aim of blunting the immune response by means of inhibiting proliferation and inducing apoptosis in primed lymphocytes. Indeed, basiliximab, one of such antibodies, has proved to be effective in reducing the episodes of acute rejection after kidney and pancreas transplantation. The use of basiliximab was associated with a significant reduction in the incidence of any treated rejection episodes after kidney transplantation in the two major randomised studies (placebo 52.2% vs basiliximab 34.2% at 6 months, European study; placebo 54.9% vs basiliximab 37.6% at 1 year, US trial). Basiliximab and equine antithymocyte globulin (ATG) administration resulted in a similar rate of biopsy-proven acute rejection at 6 months (19% for both) and at 12 months (19% and 20%, respectively). The use of basiliximab appears not to be associated with an increased incidence of adverse events as compared with placebo in immunosuppressive regimens, including calcineurin inhibitors, mycophenolate mofetil or azathioprine and corticosteroids, and its safety profile is superior to ATG. Moreover, a similar occurrence of infections is noted in selected studies (65.5% after basiliximab vs 65.7% of controls), including cytomegalovirus infection (17.3% vs 14.5%), and cytokine-release syndrome is not observed. Finally, economic analysis demonstrated lower costs of overall treatment in patients treated with basiliximab. Therefore, the use of basiliximab entails a very low risk, allows safe reduction of corticosteroid dosage and reduces the short- and mid-term rejection rates. However, the improvement in the long-term survival of kidney grafts in patients treated according to modern immunosuppressive protocols is still to be demonstrated. These conclusions are based on a systematic review of the scientific literature, indexed on Medline database, concerning the mechanism of action, therapeutic activity, safety and pharmacoeconomic evaluation of basiliximab in renal transplantation.  N. Ref:: 62

 

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[11]

TÍTULO / TITLE:  - Drug-eluting stents and glycoprotein IIb/IIIa inhibitors: combination therapy for the future.

REVISTA / JOURNAL:  - Am Heart J 2003 Oct;146(4 Suppl):S13-7.

      ●● Enlace al texto completo (gratuito o de pago) 1016/j.ahj.2003.09.004

AUTORES / AUTHORS:  - Leon MB; Bakhai A

RESUMEN / SUMMARY:  - BACKGROUND: Although coronary stenting has improved the results of coronary interventions compared to coronary angioplasty alone, in-stent restenosis remains a significant limitation of this procedure. Drug-eluting stents with or without glycoprotein IIb/IIIa inhibitor therapy represent an additional advance in the evolution of this strategy. METHODS: We review the currently available trials comparing studies of non-drug-eluting and drug-eluting stents using sirolimus and paclitaxel agents and their derivatives. RESULTS: Ten studies are available that compare drug-eluting to traditional non-drug-eluting stents. A variety of antiplatelet regimes have been used. The majority of these studies are in the process of being published. No head-to-head studies comparing different drug-eluting stents are available. CONCLUSIONS: Drug-eluting stents using sirolimus and paclitaxel in combination with enhanced antiplatelet strategies represent an important advantage over non-drug-eluting stents for the reduction of in-stent restenosis. The rate at which drug-eluting stents are adapted into widespread practice depends heavily on whether they are safe, efficacious, and cost-effective in various clinical settings.  N. Ref:: 28

 

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[12]

TÍTULO / TITLE:  - TOR inhibitors and cardiac allograft vasculopathy: is inhibition of intimal thickening an adequate surrogate of benefit?

REVISTA / JOURNAL:  - J Heart Lung Transplant 2003 May;22(5):501-4.

AUTORES / AUTHORS:  - Mehra MR; Uber PA

INSTITUCIÓN / INSTITUTION:  - Cardiomyopathy and Heart Transplantation Center, Ochsner Clinic Foundation, New Orleans, Louisiana 70121, USA. mmehra@ochsner.org  N. Ref:: 30

 

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[13]

TÍTULO / TITLE:  - FTY720: altered lymphocyte traffic results in allograft protection.

REVISTA / JOURNAL:  - Transplantation 2001 Sep 15;72(5):764-9.

AUTORES / AUTHORS:  - Brinkmann V; Pinschewer DD; Feng L; Chen S

INSTITUCIÓN / INSTITUTION:  - Novartis Pharma AG, Transplantation Research, WSJ-386.1.01, CH-4002 Basel, Switzerland.  N. Ref:: 52

 

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[14]

TÍTULO / TITLE:  - Basiliximab: a review of its use as induction therapy in renal transplantation.

REVISTA / JOURNAL:  - Drugs 2003;63(24):2803-35.

AUTORES / AUTHORS:  - Chapman TM; Keating GM

INSTITUCIÓN / INSTITUTION:  - Adis International Limited, Auckland, New Zealand. demail@adis.co.nz

RESUMEN / SUMMARY:  - Basiliximab (Simulect), a chimeric (human/murine) monoclonal antibody, is indicated for the prevention of acute organ rejection in adult and paediatric renal transplant recipients in combination with other immunosuppressive agents.Basiliximab significantly reduced acute rejection compared with placebo in renal transplant recipients receiving dual- (cyclosporin microemulsion and corticosteroids) or triple-immunotherapy (azathioprine- or mycophenolate mofetil-based); graft and patient survival rates at 12 months were similar. Significantly more basiliximab than placebo recipients were free from the combined endpoint of death, graft loss or acute rejection 3 years, but not 5 years, after transplantation.The incidence of adverse events was similar in basiliximab and placebo recipients, with no increase in the incidence of infection, including cytomegalovirus (CMV) infection. Malignancies or post-transplant lymphoproliferative disorders after treatment with basiliximab were rare, with a similar incidence to that seen with placebo at 12 months or 5 years post-transplantation. Rare cases of hypersensitivity reactions to basiliximab have been reported.The efficacy of basiliximab was similar to that of equine antithymocyte globulin (ATG) and daclizumab, and similar to or greater than that of muromonab CD3. Basiliximab was as effective as rabbit antithymocyte globulin (RATG) in patients at relatively low risk of acute rejection, but less effective in high-risk patients. Numerically or significantly fewer patients receiving basiliximab experienced adverse events considered to be related to the study drug than ATG or RATG recipients. The incidence of infection, including CMV infection, was similar with basiliximab and ATG or RATG.Basiliximab plus baseline immunosuppression resulted in no significant differences in acute rejection rates compared with baseline immunosuppression with or without ATG or antilymphocyte globulin in retrospective analyses conducted for small numbers of paediatric patients. Limited data from paediatric renal transplant recipients suggest a similar tolerability profile to that in adults. Basiliximab appears to allow the withdrawal of corticosteroids or the use of corticosteroid-free or calcineurin inhibitor-sparing regimens in renal transplant recipients.Basiliximab did not increase the overall costs of therapy in pharmacoeconomic studies.CONCLUSION: Basiliximab reduces acute rejection without increasing the incidence of adverse events, including infection and malignancy, in renal transplant recipients when combined with standard dual- or triple-immunotherapy. The overall incidence of death, graft loss or acute rejection was significantly reduced at 3 years; there was no significant difference for this endpoint 5 years after transplantation. Malignancy was not increased at 5 years. The overall efficacy, tolerability, ease of administration and cost effectiveness of basiliximab make it an attractive option for the prophylaxis of acute renal transplant rejection.  N. Ref:: 85

 

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[15]

- Castellano -

TÍTULO / TITLE:La enfermedad linfoproliferativa difusa postrasplante renal y su relacion con el virus Epstein-Barr. Experiencia de un centro. Diffuse lymphoproliferative disease after renal transplantation and its relation with Epstein-Barr virus. Experience at one center.

REVISTA / JOURNAL:  - Nefrologia. Acceso gratuito al texto completo.

      ●● Enlace a la Editora de la Revista http://www.aulamedica.es/nefrologia/ 

      ●● Cita: Nefrologia: <> 2002;22(5):463-9.

AUTORES / AUTHORS:  - Franco A; Jimenez L; Aranda I; Alvarez L; Gonzalez M; Rocamora N; Olivares J

INSTITUCIÓN / INSTITUTION:  - Servicio de Nefrologia Hospital General Alicante Maestro Alonso, 109 03010 Alicante. franco_ant@gva.es

RESUMEN / SUMMARY:  - Post-transplant lymphoproliferative disorders (PTLD) are a group of heterogeneous lymphoid proliferations in chronic immunosuppressed recipients which appear to be related to Epstein Barr Virus (EBV). Receptor EBV seronegativity, use of antilymphocyte antibodies and CMV disease have been identified as risk factors that may tigger development of PTLD. We have studied the incidence of PTLD and its relationship with EBV in 588 adult renal transplant recipients who were transplanted in our hospital from 1988 to 2001. We have also evaluated the diagnostic and therapeutic methods used, the risk factors and outcome of the patients who developed PTLD. We identified 8 recipients (4 males and 4 females), range from 18 to 67 years (mean age 45.6 years) with a median time between grafting and PTLD of 4.1 years (0.1-7 years), who developed PTLD (1.3%). Only 1 patient received OKT3 and had CMV disease, two of them (25%) had been treated with hight doses of prednisolone, another was EBV seronegative, but the rest of them (50%) had no risk factors. Two patients were diagnosed at autopsy, the diagnosis of 5 was based on the histology of biopsy and the last one by CT scans of chest-abdomen and cytology. The presence of EBV in the lymphoproliferative cells was assessed in 5 out of the 7 studied patients (71.4%). The outcome of our recipients was poor. Five out of 8 patients died shortly after diagnosis as a direct consecuence of PTLD and another of an infectious complication of the treatment (75%). The 2 patients alive started dialysis and 1 of them died 2 years later of a non-related cause. In conclusion, PTLD is a relatively frequent disease with a poor prognosis in renal transplant patients. It seems to have a close relationship with EBV and can develop in the absence of the classical risk factors.  N. Ref:: 18

 

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[16]

TÍTULO / TITLE:  - European best practice guidelines for renal transplantation. Section IV: Long-term management of the transplant recipient. IV.10. Pregnancy in renal transplant recipients.

REVISTA / JOURNAL:  - Nephrol Dial Transplant. Acceso gratuito al texto completo a partir de los 2 años de la fecha de publicación.

      ●● Enlace a la Editora de la Revista http://ndt.oupjournals.org/ 

      ●● Cita: Nephrology Dialysis Transplantation: <> 2002;17 Suppl 4:50-5.

RESUMEN / SUMMARY:  - GUIDELINES: A. Renal transplantation restores fertility, and successful pregnancies have been reported in renal transplant women. In women with normal graft function, pregnancy usually has no adverse effect on graft function and survival. Therefore, women of childbearing age who consider pregnancy should receive complete information and support from the transplant team. B. Pregnancy could be considered safe about 2 years after transplantation in women with good renal function, without proteinuria, without arterial hypertension, with no evidence of ongoing rejection and with normal allograft ultrasound. C. Pregnancy after transplantation should be considered a high-risk pregnancy and should be monitored by both an obstetrician and the transplant physician. Pregnancy should be diagnosed as early as possible. The principal risks are infection, proteinuria, anaemia, arterial hypertension and acute rejection for the mother, and prematurity and low birth weight for the foetus. D. Pregnant women and transplanted patients are at increased risk of infections, especially bacterial urinary tract infections and acute pyelonephritis of the graft. Urine cultures should be performed monthly and all asymptomatic infections should be treated. Monitoring of viral infections is also recommended. (Evidence level B) E. Acute rejection episodes are uncommon but may occur after delivery. Therefore, immunosuppression should be re-adjusted immediately after delivery. F. Because pre-eclampsia develops in 30% of pregnant patients, especially those with prior arterial transplant hypertension, blood pressure, renal function, proteinuria and weight should be monitored every 2-4 weeks, with more attention during the third trimester. Anti-hypertensive agents should be changed to those tolerated during pregnancy. ACE inhibitors and angiotensin II receptor antagonists are absolutely contra-indicated. G. Immunosuppressive therapy based on cyclosporine or tacrolimus with or without steroids and azathioprine may be continued in renal transplant women during pregnancy. Other drugs, such as mycophenolate mofetil and sirolimus, are not recommended based on current information available. Because of drug transfer into maternal milk, breastfeeding is not recommended. H. Vaginal delivery is recommended, but caesarean section is required in at least 50% of cases. Delivery should occur in a specialized centre. In the puerperium, renal function, proteinuria, blood pressure, cyclosporine/tacrolimus blood levels and fluid balance should be closely monitored.

 

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[17]

TÍTULO / TITLE:  - Cryptococcus neoformans infection in organ transplant recipients: variables influencing clinical characteristics and outcome.

REVISTA / JOURNAL:  - Emerg Infect Dis. Acceso gratuito al texto completo.

      ●● Enlace a la Editora de la Revista http://www.cdc.gov/ 

      ●● Cita: Emerging Infectious Diseases: <> 2001 May-Jun;7(3):375-81.

AUTORES / AUTHORS:  - Husain S; Wagener MM; Singh N

INSTITUCIÓN / INSTITUTION:  - Veterans Affairs Medical Center and University of Pittsburgh, Thomas E. Starzl Transplantation Institute, Pittsburgh, Pennsylvania 15240, USA.

RESUMEN / SUMMARY:  - Unique clinical characteristics and other variables influencing the outcome of Cryptococcus neoformans infection in organ transplant recipients have not been well defined. From a review of published reports, we found that C. neoformans infection was documented in 2.8% of organ transplant recipients (overall death rate 42%). The type of primary immunosuppressive agent used in transplantation influenced the predominant clinical manifestation of cryptococcosis. Patients receiving tacrolimus were significantly less likely to have central nervous system involvement (78% versus 11%, p =0.001) and more likely to have skin, soft-tissue, and osteoarticular involvement (66% versus 21%, p = 0.006) than patients receiving nontacrolimus- based immunosuppression. Renal failure at admission was the only independently significant predictor of death in these patients (odds ratio 16.4, 95% CI 1.9-143, p = 0.004). Hypotheses based on these data may elucidate the pathogenesis and may ultimately guide the management of C. neoformans infection in organ transplant recipients.  N. Ref:: 74

 

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[18]

TÍTULO / TITLE:  - Mechanisms and consequences of arterial hypertension after renal transplantation.

REVISTA / JOURNAL:  - Transplantation 2001 Sep 27;72(6 Suppl):S9-12.

AUTORES / AUTHORS:  - Koomans HA; Ligtenberg G

INSTITUCIÓN / INSTITUTION:  - Department of Nephrology and Hypertension, University Hospital Utrecht, The Netherlands. h.a.koomans@digd.azu.nl

RESUMEN / SUMMARY:  - The high incidence of hypertension after renal transplantation contributes to the risk of cardiovascular morbidity and mortality in renal transplant recipients. Although cyclosporine has been influential in the improvement of transplant outcome, it has emerged as a major cause of hypertension after organ transplantation. The underlying pathophysiological mechanisms of cyclosporine-induced hypertension include enhanced sympathetic nervous system activity, renal vasoconstriction, and sodium/water retention. Hypertension is also significantly associated with reduced graft survival and thereby requires aggressive treatment intervention. Calcium channel blockers may offer some advantages over angiotensin-converting enzyme inhibitors for the treatment of hypertension in stable renal transplant recipients. Nevertheless, selection of the most appropriate antihypertensive agent should take into account the possibility of pharmacokinetic interactions with immunosuppressive agents. There is evidence to suggest that the use of tacrolimus-based immunosuppression induces less hypertension compared with cyclosporine. Not only do patients receiving tacrolimus tend to require less antihypertensive therapy, but converting patients from cyclosporine to tacrolimus has been shown to result in significant reductions in blood pressure. Thus, tacrolimus may be associated with an improved cardiovascular risk profile in renal transplant recipients.  N. Ref:: 26

 

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[19]

TÍTULO / TITLE:  - Controlling the incidence of infection and malignancy by modifying immunosuppression.

REVISTA / JOURNAL:  - Transplantation 2001 Dec 27;72(12 Suppl):S89-93.

AUTORES / AUTHORS:  - Soulillou JP; Giral M

RESUMEN / SUMMARY:  - Long-term outcomes in renal transplantation have improved over the years but are still a matter of concern. Because patients typically require lifelong immunosuppression, the risks of cancer and infection associated with immunosuppressive agents continue to demand attention. Physicians strive endlessly to find the right balance between the level of immunosuppression required to prevent rejection and the level that will minimize dose-dependent side effects. Data presented in this paper suggest that some renal transplant recipients might have more than necessary immunosuppression during maintenance therapy and that reducing the immunosuppressant dose can decrease cancer incidence, without worsening long-term patient or allograft survival. Additionally, data were examined suggesting that immunosuppressive agents might be associated with different risks for cancer, specifically, the potential advantage of reduced cancer risk for sirolimus and sirolimus derivatives in comparison with standard immunosuppressive agents. Although promising, these preliminary results are from preclinical studies, and further study is warranted.  N. Ref:: 42

 

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[20]

TÍTULO / TITLE:  - Effect of immunosuppressive treatment protocol on malignancy development in renal transplant patients.

REVISTA / JOURNAL:  - Transplant Proc 2002 Sep;34(6):2133-5.

AUTORES / AUTHORS:  - Haberal M; Moray G; Karakayali H; Emiroglu R; Basaran O; Sevmis S; Demirhan B

INSTITUCIÓN / INSTITUTION:  - Baskent University Faculty of Medicine, Ankara, Turkey. melekk@baskent-ank.edu.tr

 

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[21]

TÍTULO / TITLE:  - Effective prophylactic protocol in delayed hypersensitivity to contrast media: report of a case involving lymphocyte transformation studies with different compounds.

REVISTA / JOURNAL:  - Radiology. Acceso gratuito al texto completo a partir de los 2 años de la publicación;  - http://radiology.rsnajnls.org/ 

      ●● Cita: Radiology: <> 2002 Nov;225(2):466-70.

AUTORES / AUTHORS:  - Romano A; Artesani MC; Andriolo M; Viola M; Pettinato R; Vecchioli-Scaldazza A

INSTITUCIÓN / INSTITUTION:  - Department of Internal Medicine and Geriatrics, Universita’ Cattolica del Sacro Cuore, Allergy Unit, Complesso Integrato Columbus, Via G. Moscati 31, 00168 Rome, Italy. columbus.allerg@linet.it

RESUMEN / SUMMARY:  - A patient with maculopapular reactions to iopamidol needed to undergo angiography for a cerebral arteriovenous malformation. In vivo and in vitro tests were performed with ionic and nonionic contrast media, including iopamidol and iobitridol. All results were positive, demonstrating delayed hypersensitivity. The patient received 6-alpha-methylprednisolone and cyclosporine 1 week before and 2 weeks after four angiograms were obtained with the use of iobitridol, which was well tolerated.

 

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[22]

TÍTULO / TITLE:  - Potential therapeutic interventions to avoid or treat chronic allograft dysfunction.

REVISTA / JOURNAL:  - Transplantation 2001 Jun 15;71(11 Suppl):SS52-7.

AUTORES / AUTHORS:  - Kahan BD

INSTITUCIÓN / INSTITUTION:  - University of Texas Medical School Houston, United States.

RESUMEN / SUMMARY:  - Despite the significant improvements that have occurred since the introduction of CsA, long-term renal allograft survival continues to be an area of concern. Management strategies that involve the use of sirolimus offer some promise. A number of observations suggest that sirolimus may have the ability to reduce the rates or slow the progression of chronic nephropathy. First, sirolimus has been shown to inhibit growth-factor-driven proliferation of endothelial and smooth muscle cells in vitro (55, 56). Sirolimus also disrupts signal transduction by a variety of other cytokines such as EGF and PDGE This is significant because cytokine- and growth-factor-stimulated proliferation of endothelial cells, smooth muscle cells, parenchymal cells, and fibroblasts appears to underlie the development of chronic nephropathy (see Fellstrom, this supplement). Second, sirolimus has been demonstrated in various animal models to inhibit the arterial intimal thickening that typically follows alloimmune or mechanical injury (56-60; see Morris, this supplement). This transplant vasculopathy is a prominent feature in chronic rejection of other organ transplants. Moreover, at least 1 published study has suggested that sirolimus may be able to stabilize and possibly reverse chronic graft vascular disease (61). However, the relative doses of sirolimus used in these animal studies have been higher than those used in humans, so the relationship of these effects to the clinical setting needs to be further studied to define the relevance of these findings. Third, sirolimus, used in combination with CsA, reduces the incidence of acute rejection episodes in humans, one of the most significant predictors of shortened renal allograft survival (62, 63). Thus, an effect of sirolimus to reduce acute rejection episodes or delay their onset is expected to reduce renal allograft loss. Furthermore, clinical trials suggest that sirolimus treatment may allow dose reductions of CsA or a delay in inception of CsA therapy, which might reduce the acute and chronic nephrotoxicity associated with CsA and other CNIs. Since nephrotoxicity may promote or aggravate renal injury and appears to be common in chronic nephropathy (see Fellstrom and Paul, this supplement), reduced exposure to CNIs may translate into reduced rates of chronic renal allograft dysfunction. There are no currently effective therapies for chronic nephropathy, which is a common cause of late renal allograft loss. Preliminary evidence suggests that sirolimus may eventually prove useful as prophylaxis of or treatment for chronic nephropathy. Thus, sirolimus has come to be regarded as the foundation for maintenance immunosuppressive regimens.  N. Ref:: 63

 

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[23]

TÍTULO / TITLE:  - Drug-eluting stents: potential applications for peripheral arterial occlusive disease.

REVISTA / JOURNAL:  - J Vasc Interv Radiol 2003 Mar;14(3):291-301.

AUTORES / AUTHORS:  - Duda SH; Poerner TC; Wiesinger B; Rundback JH; Tepe G; Wiskirchen J; Haase KK

INSTITUCIÓN / INSTITUTION:  - Department of Diagnostic Radiology, University of Tuebingen, Germany. stephan.duda@med.uni-tuebingen.de

RESUMEN / SUMMARY:  - Many different approaches have been evaluated to prevent restenosis in stents after vascular implantation. Currently, drug-eluting stents are extremely promising in suppressing neointimal hyperplasia. Various animal studies and randomized trials in humans have shown excellent results in terms of safety and efficacy during intermediate-term follow-up. This article will give an overview of experimental and clinical data of the different agents in published and ongoing trials.  N. Ref:: 87

 

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[24]

TÍTULO / TITLE:  - Engineered CD3 antibodies for immunosuppression.

REVISTA / JOURNAL:  - Clin Exp Immunol 2003 Sep;133(3):307-9.

AUTORES / AUTHORS:  - Renders L; Valerius T  N. Ref:: 30

 

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[25]

TÍTULO / TITLE:  - Risk factors for bronchiolitis obliterans: a systematic review of recent publications.

REVISTA / JOURNAL:  - J Heart Lung Transplant 2002 Feb;21(2):271-81.

AUTORES / AUTHORS:  - Sharples LD; McNeil K; Stewart S; Wallwork J

INSTITUCIÓN / INSTITUTION:  - Medical Research Council (MRC) Biostatistics Unit, University Forvie Site, Papworth Everard, Cambridge, United Kingdom. linda.sharples@mrc-bsu.cam.ac.uk

RESUMEN / SUMMARY:  - BACKGROUND: Obliterative bronchiolitis remains the major limitation to long-term survival after lung transplantation. A thorough understanding of the factors that confer high risk of developing obliterative bronchiolitis or its physiologic surrogate bronchiolitis obliterans syndrome is important to help define therapeutic strategies. METHODS: We performed a systematic review of studies published since the beginning of 1990. The review excluded non-human studies, publications before 1990, small (less than 25 patients) studies that were predominantly concerned with investigating the pathogenesis of obliterative bronchiolitis, studies solely concerned with diagnosis or treatment of obliterative bronchiolitis, and overlapping studies from the same center. Onset of bronchiolitis obliterans syndrome or obliterative bronchiolitis was the outcome of interest. RESULTS: Acute rejection plays an important role in obliterative bronchiolitis and bronchiolitis obliterans syndrome onset, and late rejection is a significant risk factor. Lymphocytic bronchitis/bronchiolitis is also a risk factor, with some evidence that late onset is associated with greater risk. The effects of cytomegalovirus, other infectious organisms, and human leukocyte antigen matching are less clear and require further confirmation. There is little evidence that recipient and donor characteristics play a major role. CONCLUSIONS: This systematic review supports the view that obliterative bronchiolitis arises from alloimmunologic injury marked by clinically apparent acute rejection episodes and that inflammatory conditions, including viral infections or ischemic injury, may also play a role. Implications for therapy are discussed.  N. Ref:: 28

 

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[26]

TÍTULO / TITLE:  - Use of nonsteroidal topical immunomodulators for the treatment of atopic dermatitis in the pediatric population.

REVISTA / JOURNAL:  - J Pediatr 2001 Feb;138(2):163-8.

AUTORES / AUTHORS:  - Paller AS

INSTITUCIÓN / INSTITUTION:  - Department of Pediatrics, Children’s Memorial Hospital, Northwestern University Medical School, Chicago, Illinois, USA.  N. Ref:: 39

 

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[27]

TÍTULO / TITLE:  - The porcine coronary model of in-stent restenosis: current status in the era of drug-eluting stents.

REVISTA / JOURNAL:  - Catheter Cardiovasc Interv 2003 Dec;60(4):515-23.

      ●● Enlace al texto completo (gratuito o de pago) 1002/ccd.10705

AUTORES / AUTHORS:  - Lowe HC; Schwartz RS; Mac Neill BD; Jang IK; Hayase M; Rogers C; Oesterle SN

INSTITUCIÓN / INSTITUTION:  - Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA. h.lowe@unsw.edu.au

RESUMEN / SUMMARY:  - Drug-eluting stents are revolutionizing interventional cardiology. Sirolimus-eluting stents are in widespread clinical use, associated with well-documented remarkably low restenosis rates, and a number of other agents appear promising in clinical trials. These human studies have been preceded by numerous animal studies, foremost among them the pig coronary model of in-stent restenosis (ISR). The histologic response to porcine coronary stenting was described over a decade ago. Porcine stenting studies now provide examinations not only of histology, but also mechanisms of action, toxicity, and biocompatibility. This review therefore examines the current status of this porcine coronary model of ISR. Contemporary methods of pig coronary stenting are discussed. The morphometric, cellular, and molecular analyses of the responses to stent injury are then described. Finally, recent pig coronary drug-eluting stent studies are examined, with a discussion of their advantages, limitations, and possible future modifications.  N. Ref:: 51

 

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[28]

TÍTULO / TITLE:  - Drug-eluting stents in peripheral vascular disease: eliminating restenosis.

REVISTA / JOURNAL:  - Mt Sinai J Med. Acceso gratuito al texto completo.

      ●● Enlace a la Editora de la Revista http://www.mssm.edu/msjournal/ 

      ●● Cita: Mount Sinai J. of Medicine, New York: <> 2003 Nov;70(6):417-9.

AUTORES / AUTHORS:  - Ellozy SH; Carroccio A

INSTITUCIÓN / INSTITUTION:  - Department of Surgery, Mount Sinai School of Medicine, One East 100th Street, New York, NY 10029, USA. sharif.ellozy@msnyuhealth.org

RESUMEN / SUMMARY:  - Transcatheter endovascular therapy for peripheral atherosclerotic disease has become more popular. In general, good results have been reported in focal aortoiliac disease. However, the long-term patency of angioplasty in longer, more distal lesions has been less satisfactory. Stenting has not been shown to improve long-term patency compared to angioplasty alone. Drug-eluting stents have shown promise in preventing coronary restenosis, and preliminary results in peripheral arterial disease are encouraging. This review article will discuss the current status of endovascular therapy of aortoiliac and femoropopliteal atherosclerotic disease, the theoretic and experimental basis for the use of drug-eluting stents, and the preliminary results in human studies.  N. Ref:: 48

 

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[29]

TÍTULO / TITLE:  - Rejection rate in living donor kidney transplantation with and without basiliximab in tacrolimus/mycophenolate mofetil-based protocol.

REVISTA / JOURNAL:  - Transplant Proc 2003 Mar;35(2):653-4.

AUTORES / AUTHORS:  - Rahamimov R; Yussim A; After T; Lustig S; Bar-Nathan N; Shaharabani E; Shapira Z; Shabthai E; Mor E

INSTITUCIÓN / INSTITUTION:  - Department of Transplantation, Rabin Medical Center, Beilinson Campus, Petah-Tiqwa, Israel. rutir@clalit.org.il

 

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[30]

- Castellano -

TÍTULO / TITLE:Presentacion de canceres en receptores trasplantados con organo solido. Presentation of cancers in recipients of a solid-organ transplant.

REVISTA / JOURNAL:  - Nefrologia. Acceso gratuito al texto completo.

      ●● Enlace a la Editora de la Revista http://www.aulamedica.es/nefrologia/ 

      ●● Cita: Nefrologia: <> 2001;21(6):528-37.

AUTORES / AUTHORS:  - Lampreabe I; Gomez-Ullate P; Amenabar JJ; Zarraga S; Gainza FJ; Urbizu JM

INSTITUCIÓN / INSTITUTION:  - Servicio de Nefrologia, Hospital de Cruces, Facultad de Medicina, Universidad del Pais Vasco. ilampreave@hcru.osakidetza.net  N. Ref:: 35

 

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[31]

TÍTULO / TITLE:  - Limited dose monoclonal IL-2R antibody induction protocol after primary kidney transplantation.

REVISTA / JOURNAL:  - Am J Transplant 2002 Jul;2(6):568-73.

AUTORES / AUTHORS:  - Ahsan N; Holman MJ; Jarowenko MV; Razzaque MS; Yang HC

INSTITUCIÓN / INSTITUTION:  - Nephrology and Transplant Division, University of Medicine and Dentistry of New Jersey, New Brunswick 08904, USA. ahsanna@umdnj.edu

RESUMEN / SUMMARY:  - This study prospectively compared immunoprophylaxis with a single intraoperative dose (2 mg/kg) of monoclonal interleukin-2 receptor (IL-2R) antibody vs. noninduction in kidney transplant recipients treated with tacrolimus (FK 506), mycophenolate mofetil (MMF) and a prednisone-based immunosuppression regimen. One hundred recipients of first-kidney transplant were enrolled into the study to receive either anti-IL-2R monoclonal antibody, daclizumab (2 mg/kg intraoperatively, limited anti-IL-2R) or no induction (control). Each patient also received oral tacrolimus (dosed to target trough level 10-15 ng/mL), MMF (500 mg bid) and prednisone. The primary efficacy end-point was the incidence of biopsy proven acute rejection during the first 6 months post-transplant. The patients were also followed for 12-month graft function, and graft and patient survival rates. Other than the donor’s age being significantly lower in the control group, both groups were comparable with respect to age, weight, gender, race, human leukocyte antigen (HLA)-DR mismatch, panel reactive antibody (%PRA), cold ischemic time, cytomegalovirus (CMV) status, causes of renal failure, and duration and modes of renal replacement therapy (RRT). During the first 6 months, episodes of first biopsy confirmed acute rejection was 3/50 (6%) in the limited anti-IL-2R group and 8/50 (16%) in the controls (p < 0.05). Twelve-month patient 100/98 (%) and graft survival 100/96 (%) were not statistically different. The group receiving limited anti-IL-2R did not have any adverse reactions. Our study demonstrates that a limited (single) 2 mg/kg immunoprophylaxis dose with monoclonal IL-2R antibody (daclizumab) when combined with tacrolimus/MMF/steroid allows significant reduction in early renal allograft rejection to the single digit level. The therapy with anti-IL-2R antibody is simple and is well tolerated.

 

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[32]

TÍTULO / TITLE:  - Antioxidant nutrients protect against cyclosporine A nephrotoxicity.

REVISTA / JOURNAL:  - Toxicology 2003 Jul 15;189(1-2):99-111.

AUTORES / AUTHORS:  - Parra Cid T; Conejo Garcia JR; Carballo Alvarez F; de Arriba G

INSTITUCIÓN / INSTITUTION:  - Unidad de Investigacion, Hospital Universitario de Guadalajara, C/Donante de Sangre s/n, 19.002 Guadalajara, España. tparracid@hotmail.com

RESUMEN / SUMMARY:  - The immunosuppressive drug cyclosporine A (CsA) has been successfully used in several diseases with immunological basis and in transplant patients. Nephrotoxicity is the main secondary effect of CsA treatment. Although the mechanisms of nephrotoxitity are not completely defined, there is evidence that suggests the role of reactive oxygen species (ROS) in its pathogenesis. It has been demonstrated in numerous in vivo and in vitro experiments that CsA induced renal failure and increased the synthesis of ROS, thromboxane (TX) and lipid peroxidation products in the kidney. Furthermore, CsA modified the expression and activity of several renal enzymes (ciclooxygenase, superoxide-dismutase, catalase and glutathione-peroxidase). Antioxidant nutrients (e.g. Vitamins E and C) can neutralize some of the effects that CsA produced in the kidney. Thus, Vit E inhibited the synthesis of ROS and TX and the lipid peroxidation process induced by CsA in kidney structures. Antioxidants can also improve renal function and histological damage produced by CsA administration. Although there are few data in humans treated with CsA, the possibility exists that antioxidants can also neutralize CsA nephrotoxicity and LDL oxidation. Thus, antioxidant nutrients could have a therapeutic role in transplant patients treated with CsA.  N. Ref:: 79

 

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[33]

TÍTULO / TITLE:  - Role of prostanoids and endothelins in the prevention of cyclosporine-induced nephrotoxicity.

REVISTA / JOURNAL:  - Prostaglandins Leukot Essent Fatty Acids 2001 Apr-May;64(4-5):231-9.

      ●● Enlace al texto completo (gratuito o de pago) 1054/plef.2001.0265

AUTORES / AUTHORS:  - Darlametsos IE; Varonos DD

INSTITUCIÓN / INSTITUTION:  - Centre Franco-Hellenique de Recherches Biomedicales, Nikolaos Papanikolaou, Corporation of the Municipality Agrinion, Agrinion, 30100, Greece. darlamet@otenet.gr

RESUMEN / SUMMARY:  - Cyclosporine A nephrotoxicity includes both functional toxicity and histological changes, whose seriousness is dependent upon the dose and the duration of the drug administration. Several vasoactive agents have been found to be implicated in cyclosporine induced nephrotoxicity, among which prostanoids and endothelins are the most important. In previous studies we were able to prevent the early stage (7 days) of cyclosporine (37.4 micromol [45 mg]/kg/day) induced nephrotoxicity in rats either by the administration, i) of OKY-046, a thromboxane A(2)synthase inhibitor, ii) of ketanserine, an antagonist of S(2)serotonergic, a(1)adrenergic, and H(1)histaminergic receptors and iii) of nifedipine, a calcium channel blocker, or by diet supplementation either with evening primrose oil or fish oil. All these protective agents elevated ratios of excreted renal prostanoid vasodilators (prostaglandins E(2), 6ketoF(1 alpha)) to vasoconstrictor (thromboxane B(2)), a ratio which was decreased by the administration of cyclosporine alone. Nifedipine averted the cyclosporine induced increase of urinary endothelin-1 release. All protections were associated with the reinstatement of glomerular filtration rate forwards normal levels whereas renal damage defence, consisting of a decrease of the cyclosporine induced vacuolizations, was variable. Ketanserine and evening primrose oil were the only agents which prevented the animal body weight loss. These data suggest that prostanoids and endothelin-1 may mediate functional toxicity while thromboxane A(2)is involved the morphological changes too, provoked in the early stage of cyclosporine treatment. However, other nephrotoxic factors and additional mechanisms could also be implicated in the cyclosporine induced nephrotoxicity.  N. Ref:: 91

 

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[34]

TÍTULO / TITLE:  - New strategies to reduce nephrotoxicity.

REVISTA / JOURNAL:  - Transplantation 2001 Dec 27;72(12 Suppl):S99-104.

AUTORES / AUTHORS:  - Kreis H

RESUMEN / SUMMARY:  - Since the introduction of cyclosporine, CNIs have formed the basis of immunosuppressive therapy in renal transplantation. The propensity of these agents to ultimately damage the very organs they were intended to protect was always recognized, but largely ignored due to their impressive ability to improve short-term outcomes. With the availability of equally powerful new immunosuppressive agents devoid of major nephrotoxicity, the irony of this situation has become all too apparent, and investigators are beginning to reevaluate the role of CNIs in renal transplantation. In this paper, we looked at strategies using MMF or sirolimus to reduce, withdraw, or replace CNIs in renal transplantation. Although MMF has proved effective in combination with CNIs, particularly in reducing acute rejection rates, its use as base therapy to allow CNI therapy to be withdrawn or eliminated is questionable. On the basis of initial trials, sirolimus holds promise for use as base therapy. To date, it is probably the only agent used in renal transplantation that provides immunosuppression comparable to cyclosporine or tacrolimus, which may someday allow sirolimus to replace. CNIs or allow early withdrawal of CNI therapy. Further study is needed to better clarify the role of sirolimus in improving long-term renal transplantation outcomes.  N. Ref:: 61

 

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[35]

TÍTULO / TITLE:  - Molecular actions of sirolimus: sirolimus and mTor.

REVISTA / JOURNAL:  - Transplant Proc 2003 May;35(3 Suppl):227S-230S.

AUTORES / AUTHORS:  - Kirken RA; Wang YL

INSTITUCIÓN / INSTITUTION:  - Department of Integrative Biology and Pharmacology, The University of Texas Health Science Center at Houston, Houston, Texas 77030, USA. robert.a.kirken@uth.tmc.edu

RESUMEN / SUMMARY:  - Recent therapeutic strategies to combat organ allograft rejection have focused on T-cell signaling pathways and the molecules that comprise them. The macrolide antibiotic produced by the bacterium Streptomyces hygroscopicus, known as sirolimus or rapamycin, has shown great therapeutic potential in the transplant setting. Sirolimus alone or in combination with other immunosuppressive agents can block acute rejection, chronic graft destruction, and promote permanent allograft acceptance. Sirolimus targets a unique serine-threonine kinase, mammalian target of rapamycin (mTor), which plays a key role in mitogenic and nutritional cells signals. Within T cells, mTor regulates a number of proteins likely dependent on T cell growth factors such as interleukin 2. This review is focused on the molecular mechanisms by which mTor may regulate T-cell signaling cascades and affect T-cell responsiveness, and how sirolimus likely uncouples this activity.  N. Ref:: 32

 

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[36]

TÍTULO / TITLE:  - Long-term kidney transplant survival.

REVISTA / JOURNAL:  - Am J Kidney Dis 2001 Dec;38(6 Suppl 6):S44-50.

AUTORES / AUTHORS:  - Hariharan S

INSTITUCIÓN / INSTITUTION:  - Froedert Memorial Hospital, Medical College of Wisconsin, Milwaukee, WI 53226, USA. hari@mcw.edu

RESUMEN / SUMMARY:  - With improvements in short-term kidney graft survival, focus has shifted towards long-term survival. There has also been a substantial improvement in long-term survival as measured by kidney half-life. Long-term graft failure is secondary to chronic allograft nephropathy (CAN), recurrent disease, and death with a functioning graft. CAN is secondary to a combination of chronic rejection, chronic cyclosporine toxicity, and/or donor kidney disease. Risk factors for chronic rejection have been attributed to both immunological and nonimmunological causes. With a marked reduction in acute rejection rates-an important risk factor for CAN-there is a substantial improvement in kidney half-life. There are still nonimmunological factors, such as donor age, that adversely affect long-term graft survival. In addition, African-American recipients continue to have a shorter graft half-life. Recurrent disease is becoming an important cause of late graft failure. Despite the introduction of various potent immunosuppressive agents, there has been little or no impact on the prevalence as well as progression of recurrent diasease. With the reduction of acute rejection rates and improved short- and long-term graft survival, further improvements of long-term graft survival will be an important focus in the 21st century.  N. Ref:: 45

 

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[37]

TÍTULO / TITLE:  - Prevention strategies for type 1 diabetes mellitus: current status and future directions.

REVISTA / JOURNAL:  - BioDrugs 2003;17(1):39-64.

AUTORES / AUTHORS:  - Winter WE; Schatz D

INSTITUCIÓN / INSTITUTION:  - Department of Pathology, University of Florida, Gainesville, Florida 32610, USA. winter@pathology.ufl.edu

RESUMEN / SUMMARY:  - Type 1 diabetes mellitus affects about 1 in 300 people in North America and Europe. Epidemiological studies indicate that the incidence and thus prevalence of type 1 diabetes is rising worldwide. Intervention in autoimmune type 1a diabetes could occur at the time of diagnosis or, preferably, prior to clinical presentation during the ‘prediabetic’ period (e.g. prevention). Prediabetes is best recognised by the detection of islet autoantibodies in the serum. Promising intervention strategies include monoclonal antibody therapies (e.g. anti-CD3, anti-CD25, anti-CD52 or anti-CD20 monoclonal antibodies), immunosuppression (e.g. calcineurin inhibitors, B7 blockade, glucocorticoids, sirolimus (rapamycin), azathioprine or mycophenolate mofetil), immunomodulatory therapies (e.g. plasmapheresis, intravenous immunoglobulin, cytokine administration, adoptive cellular gene therapy) and tolerisation interventions (e.g. autoantigen administration or avoidance, altered peptide ligand or peptide-based therapies). To date, islet and pancreas transplantation have essentially been reserved for patients with long-standing diabetes who have complications and are also in need of a concurrent kidney transplant. None of the therapies attempted to date has produced long-term remissions in new-onset type 1 diabetes patients and no therapies have been shown to prevent the disease. Nevertheless, with advances in our understanding of basic immunology and the cellular and molecular mechanisms of tolerance induction and maintenance, successful intervention therapies will be developed. The balance between safety and efficacy is critical. Higher rates of adverse events might be more tolerable in new-onset type 1 diabetes patients if the therapy is extremely effective at inducing a permanent remission. However, therapies must not harm the beta-cells themselves or any organ system that is a potential target of diabetes complications, such as the nervous system, retina, cardiovascular system or kidney. In the treatment of prediabetes, successful therapies should provide a level of safety similar to that of currently used vaccines and a high level of efficacy.  N. Ref:: 244

 

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[38]

TÍTULO / TITLE:  - Tailoring immunosuppressive therapy based on donor and recipient risk factors.

REVISTA / JOURNAL:  - Transplant Proc 2001 May;33(3):2207-11.

AUTORES / AUTHORS:  - First MR

INSTITUCIÓN / INSTITUTION:  - University of Cincinnati Medical Center, Cincinnati, Ohio 45267-0585, USA.  N. Ref:: 35

 

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[39]

TÍTULO / TITLE:  - Novel pharmacotherapeutic approaches to prevention and treatment of GVHD.

REVISTA / JOURNAL:  - Drugs 2002;62(6):879-89.

AUTORES / AUTHORS:  - Jacobsohn DA; Vogelsang GB

INSTITUCIÓN / INSTITUTION:  - Oncology and Pediatrics, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. jacobda@jhmi.edu

RESUMEN / SUMMARY:  - Acute and chronic graft versus host disease (GVHD) remain the major barriers to successful hematopoietic cell transplantation. The induction of GVHD may be divided into three phases: recipient conditioning;donor T-cell activation; andeffector cells mediating GVHD. This review examines GVHD prevention and treatment using this conceptual model as framework. The various pharmacological agents discussed impact on different phases of the GVHD cascade. For example, keratinocyte growth factor and interleukin (IL)-11 are cytokines that may be useful in disrupting phase I of the GVHD cascade by blocking gastrointestinal tract damage, and lowering serum levels of lipopolysaccharide and tumour necrosis factor (TNF)-alpha. Cyclosporin, tacrolimus (FK-506) and sirolimus (rapamycin) are some of the main agents that disrupt phase II (donor T-cell activation). Mycophenolate mofetil and tresperimus probably act on this phase as well. Other novel drugs that affect phase II are tolerance-induction agents such as CTLA-4 and anti-CD40-ligand monoclonal antibodies, and preliminary results using CTLA-4 monoclonal antibody in GVHD prevention are encouraging. Examples of agents that disrupt phase III are the IL-2 receptor antagonist daclizumab and the anti-TNFalpha monoclonal antibody infliximab. These anti-cytokine antibodies have shown promising results in early studies. The most effective approach to GVHD prevention will probably be a combination regimen where the three phases of the GVHD cascade are disrupted. Once GVHD has occurred, all three phases of the cascade are activated. Developments of combination therapy for treatment of both acute and chronic GVHD are likely to yield better results than monotherapy. The numerous new treatment modalities presented should improve the outlook for patients with acute and chronic GVHD.  N. Ref:: 74

 

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[40]

TÍTULO / TITLE:  - Incidence and spectrum of infections in lung transplanted patients: comparison of four different immunosuppressive protocols.

REVISTA / JOURNAL:  - Transplant Proc 2001 Feb-Mar;33(1-2):1620-1.

AUTORES / AUTHORS:  - Treede H; Reichenspurner H; Meiser BM; Kur F; Furst H; Vogelmeier C; Briegel J; Reichart B

INSTITUCIÓN / INSTITUTION:  - University Hospital Grosshadern, Munich, Germany.

 

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[41]

TÍTULO / TITLE:  - Early clinical experience with a novel rapamycin derivative.

REVISTA / JOURNAL:  - Ther Drug Monit 2002 Feb;24(1):53-8.

AUTORES / AUTHORS:  - Nashan B

INSTITUCIÓN / INSTITUTION:  - Klinik fur Viszeral-und Transplantationschirurgie, Medizinische Hochschule Hannover, Hannover, Germany. nashan@tx-amb.mh-hannover.de

RESUMEN / SUMMARY:  - SDZ RAD (everolimus, Certican is a novel macrolide immunosuppressant that blocks growth factor-driven transduction signals in the T-cell response to alloantigen. After stimulation of the IL-2 receptor on the activated T-cell, SDZ RAD inhibits p70S6 kinase, acting at a later stage in the T-cell mediated response than do cyclosporine and other calcineurin inhibitors (CNIs). Unlike the CNIs, SDZ RAD is a proliferation signal inhibitor, blocking growth factor-driven proliferation of both hematopoietic and nonhematopoietic cells. These activities are complementary to those of cyclosporine and provide a rationale for the addition of SDZ RAD to cyclosporine-based immunosuppression, with the potential for minimizing CNI nephrotoxicity, reducing the incidence of acute rejection, and favoring long-term graft survival. Potential also exists for beneficial effects on other factors that may influence the development of chronic rejection. These factors include comorbid diseases such as hypertension, which may affect transplant vasculopathy, and opportunistic infection with cytomegalovirus (CMV) and other viruses, which may increase the risk of chronic rejection. The synergistic effect of SDZ RAD and cyclosporine has been confirmed in preclinical models, with graft survival being significantly prolonged in rat models of kidney and heart allotransplantation. Clinical experience with SDZ RAD in cyclosporine-based immunosuppression, including low-dose cyclosporine regimens, has also resulted in predictable and favorable clinical outcomes. Low rates of acute rejection, excellent rates of patient and graft survival, lower incidence of CMV infections, better cholesterol, triglyceride and creatinine profiles, and better renal function have been demonstrated with SDZ RAD and lower doses of cyclosporine (Neoral; Novartis) in recipients of renal transplants. These findings, combined with good tolerability rates and an acceptable side-effect profile, indicate that the synergistic profile of SDZ RAD in combination with nontoxic dosages of CNI’s and IL2 inhibitors will further improve longterm results in renal transplantation.  N. Ref:: 48

 

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[42]

TÍTULO / TITLE:  - The role of newer monoclonal antibodies in renal transplantation.

REVISTA / JOURNAL:  - Transplant Proc 2001 Feb-Mar;33(1-2):1000-1.

AUTORES / AUTHORS:  - Vincenti F

INSTITUCIÓN / INSTITUTION:  - University of California, San Francisco, California, USA.  N. Ref:: 5

 

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[43]

TÍTULO / TITLE:  - Daclizumab: a review of its use in the management of organ transplantation.

REVISTA / JOURNAL:  - BioDrugs 2001;15(11):745-73.

AUTORES / AUTHORS:  - Carswell CI; Plosker GL; Wagstaff AJ

INSTITUCIÓN / INSTITUTION:  - Adis International Limited, Auckland, New Zealand. demail@adis.co.nz

RESUMEN / SUMMARY:  - The humanised monoclonal antibody daclizumab is an immunosuppressive agent that reduces acute rejection in solid organ transplantation. It is specific for the alpha subunit (Tac/CD25) of the interleukin (IL)-2 receptor on activated T cells and achieves immunosuppression by competitive antagonism of IL-2-induced T cell proliferation. When added to standard triple immunosuppression regimens, daclizumab significantly reduces the rate of acute rejection at 1 year in renal transplantation by 36% and there are indications that it may be effective in other solid organ transplantations. Three-year outcomes of two phase III clinical trials in renal transplantation indicate similar values for graft and patient survival between daclizumab and placebo when given in addition to triple immunosuppression; however, these pivotal trials were not designed with sufficient power to demonstrate any statistical significance. The addition of daclizumab induction shows potential in allowing calcineurin inhibitor- and corticosteroid-sparing regimens without increasing the rate of acute graft rejection or adverse effects in renal and liver transplantation. Preliminary reports indicate that daclizumab may also be a useful agent in delayed graft function and graft versus host disease (GVHD). Further investigation of its efficacy in these groups and in children is needed. Data from clinical trials show daclizumab to be well tolerated in solid organ transplantation. It does not increase the incidence of infection, including cytomegalovirus infection, when compared with placebo or no induction groups. Preliminary comparative data with muromonab CD3 indicate that daclizumab may be associated with a lower rate of infectious complications and similar or better efficacy. CONCLUSIONS: In conclusion, daclizumab has been proven to reduce acute rejection in renal transplant recipients when given in addition to traditional baseline immunosuppression. It has shown potential to reduce acute rejection in other solid organ transplants; however, well designed, randomised studies are required to confirm this. Clinical experience from trials to date indicate that daclizumab has a tolerability profile similar to placebo with no significant effect on the incidence of infection. The relative efficacy and tolerability of daclizumab compared with other induction agents has yet to be defined. Available data suggest that daclizumab may allow the use of calcineurin inhibitor-sparing and corticosteroid-sparing regimens and may have potential in the treatment of GVHD.  N. Ref:: 80

 

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[44]

TÍTULO / TITLE:  - In-stent stenosis: pathology and implications for the development of drug eluting stents.

REVISTA / JOURNAL:  - Heart 2003 Feb;89(2):218-24.

AUTORES / AUTHORS:  - Bennett MR

INSTITUCIÓN / INSTITUTION:  - Addenbrooke’s Centre for Clinical Investigation, Box 110, Addenbrooke’s Hospital, Cambridge CB2 2QQ, UK. mrb@mole.bio.cam.ac.uk  N. Ref:: 20

 

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[45]

TÍTULO / TITLE:  - Strategies to reduce toxicities and improve outcomes in renal transplant recipients.

REVISTA / JOURNAL:  - Pharmacotherapy 2002 Mar;22(3):316-28.

AUTORES / AUTHORS:  - Lo A; Alloway RR

INSTITUCIÓN / INSTITUTION:  - Department of Surgery, University of Cincinnati Medical Center, Ohio 45267-0585, USA.

RESUMEN / SUMMARY:  - Ongoing improvements in immunosuppression and posttransplantation care have dramatically improved patient and graft outcomes after transplantation. The frequency of graft loss due to acute rejection has declined considerably as a result of the availability of a variety of more potent immunosuppressive agents and probably also because of refined clinical care and follow-up. Complications of long-term administration of corticosteroids (steroids) and calcineurin inhibitors, however, have become increasingly apparent as patients live longer with their transplant, and attention is shifting to long-term issues. Use of both steroids and calcineurin inhibitors is associated with metabolic toxicities such as hypertension, hyperlipidemia, diabetes, bone loss, and cataracts. These contribute to posttransplantation morbidity and may negatively affect patient and allograft survival. A variety of troublesome cosmetic side effects, such as hirsutism, gingival hyperplasia, alopecia, obesity, and cushingoid appearance, also are associated with these drugs. These effects can detract from patient self-esteem and compliance with the immunosuppressive regimen. In the past 2 decades, the introduction of second-generation immunosuppressive drugs, such as tacrolimus, mycophenolate mofetil, sirolimus, and anti-interleukin-2 receptor monoclonal antibodies, has provided some alternatives to classic immunosuppressant choices. Patients experiencing undesirable adverse events now can be converted to another immunosuppressive regimen that ultimately will improve graft and patient survival rates and improve quality of life after transplantation.  N. Ref:: 99

 

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[46]

TÍTULO / TITLE:  - Tacrolimus: a further update of its use in the management of organ transplantation.

REVISTA / JOURNAL:  - Drugs 2003;63(12):1247-97.

AUTORES / AUTHORS:  - Scott LJ; McKeage K; Keam SJ; Plosker GL

INSTITUCIÓN / INSTITUTION:  - Adis International Limited, Auckland, New Zealand. demail@adis.co.nz

RESUMEN / SUMMARY:  - Extensive clinical use has confirmed that tacrolimus (Prograf) is a key option for immunosuppression after transplantation. In large, prospective, randomised, multicentre trials in adults and children receiving solid organ transplants, tacrolimus was at least as effective or provided better efficacy than cyclosporin microemulsion in terms of patient and graft survival, treatment failure rates and the incidence of biopsy-proven acute and corticosteroid-resistant rejection episodes. Notably, the lower incidence of rejection episodes after renal transplantation in tacrolimus recipients was reflected in improved cost effectiveness. In bone marrow transplant (BMT) recipients, the incidence of tacrolimus grade II-IV graft-versus-host disease was significantly lower with tacrolimus than cyclosporin treatment. Efficacy was maintained in renal and liver transplant recipients after total withdrawal of corticosteroid therapy from tacrolimus-based immunosuppression, with the incidence of acute rejection episodes at up to 2 years’ follow-up being similar with or without corticosteroids. Tacrolimus provided effective rescue therapy in transplant recipients with persistent acute or chronic allograft rejection or drug-related toxicity associated with cyclosporin treatment. Typically, conversion to tacrolimus reversed rejection episodes and/or improved the tolerability profile, particularly in terms of reduced hyperlipidaemia. In lung transplant recipients with obliterative bronchiolitis, conversion to tacrolimus reduced the decline in and/or improved lung function in terms of forced expiratory volume in 1 second. Tolerability issues may be a factor when choosing a calcineurin inhibitor. Cyclosporin tends to be associated with a higher incidence of significant hypertension, hyperlipidaemia, hirsutism, gingivitis and gum hyperplasia, whereas the incidence of some types of neurotoxicity, disturbances in glucose metabolism, diarrhoea, pruritus and alopecia may be higher with tacrolimus treatment. Renal function, as assessed by serum creatinine levels and glomerular filtration rates, was better in tacrolimus than cyclosporin recipients at up to 5 years’ follow-up. CONCLUSION: Recent well designed trials have consolidated the place of tacrolimus as an important choice for primary immunosuppression in solid organ transplantation and in BMT. Notably, in adults and children receiving transplants, tacrolimus-based primary immunosuppression was at least as effective or provided better efficacy than cyclosporin microemulsion treatment in terms of patient and graft survival, treatment failure and the incidence of acute and corticosteroid-resistant rejection episodes. The reduced incidence of rejection episodes in renal transplant recipients receiving tacrolimus translated into a better cost effectiveness relative to cyclosporin microemulsion treatment. The optimal immunosuppression regimen is ultimately dependent on balancing such factors as the efficacy of the individual drugs, their tolerability, potential for drug interactions and pharmacoeconomic issues.  N. Ref:: 261

 

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[47]

TÍTULO / TITLE:  - Post-liver transplant obesity and diabetes.

REVISTA / JOURNAL:  - Curr Opin Clin Nutr Metab Care 2003 Jul;6(4):457-60.

      ●● Enlace al texto completo (gratuito o de pago) 1097/01.mco.0000078994.96795.d8

AUTORES / AUTHORS:  - T D  Correia MI; Rego LO; Lima AS

INSTITUCIÓN / INSTITUTION:  - Alfa Institute of Gastroenterology, University Hospital, Federal University of Minas Gerais, Brazil. Isabel_correia@uol.com.br

RESUMEN / SUMMARY:  - PURPOSE OF REVIEW: Post-liver transplant patients present a vast array of metabolic changes in the early and late phase which impact on their morbidity and mortality. The development of obesity and diabetes in these patients has been widely described in the literature with several hypotheses suggested: liver donor, nutritional and metabolic state, and immunosuppressive drugs. RECENT FINDINGS: Most that is known about the development of these metabolic derangements has been attributed to the drugs used, especially the corticosteroids. When these have been used in higher doses for longer periods to treat rejection, the incidence of diabetes and obesity seems to be higher. However cyclosporine and to a lesser extent tacrolimus are also related to these alterations. SUMMARY: As long-term survival improves in liver transplant patients, cardiovascular complications associated with dyslipidemia, obesity, and diabetes are emerging as risk factors for late morbidity and mortality. Therefore, it is important to assess the potential risk factors related to these complications, in order to prevent or decrease their incidence. From what has been seen, immunossupressive drugs seem to be the greatest risk factor for the development of metabolic derangements in post-transplantation patients. However other risk factors might also be involved, such as non-healthy eating habits and lack of exercise. The latter can be preventable if counseling policies are targeted at these patients in the pre-transplantation phase and continued after the operation.  N. Ref:: 27

 

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[48]

TÍTULO / TITLE:  - Sirolimus-based immunosuppressive [correction of immunosuppresive] protocol for calcineurin sparing in liver transplantation.

REVISTA / JOURNAL:  - Transplant Proc 2002 Aug;34(5):1522-3.

AUTORES / AUTHORS:  - Heffron TG; Smallwood GA; Davis L; Martinez E; Stieber AC

INSTITUCIÓN / INSTITUTION:  - Department of Surgery, Emory University School of Medicine, Atlanta, GA 30322, USA.

 

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[49]

TÍTULO / TITLE:  - Immunosuppressive drug use in pregnancy.

REVISTA / JOURNAL:  - Autoimmunity 2003 Feb;36(1):51-6.

AUTORES / AUTHORS:  - Petri M

INSTITUCIÓN / INSTITUTION:  - Johns Hopkins University School of Medicine, 1830 E. Monument Street, Suite 7500, Baltimore, MD 21205, USA.

RESUMEN / SUMMARY:  - Ideally, immunosuppressive drugs would not be necessary in pregnancy. However, in connective tissue disease (especially systemic lupus erythematosus, SLE) vasculitis, and sometimes antiphospholipid antibody syndrome, their use is necessary both to protect the health of the mother and to insure the success of the pregnancy. The more commonly used drugs will be reviewed, with an emphasis on human data, when available. Methotrexate and leflunamide will not be considered, for they should never be used in pregnancy.  N. Ref:: 105

 

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[50]

TÍTULO / TITLE:  - Immunosuppression protocols for HLA identical renal transplant recipients.

REVISTA / JOURNAL:  - Transplant Proc 2003 May;35(3):1074-5.

AUTORES / AUTHORS:  - Keitel E; Santos AF; Alves MA; Neto JP; Schaefer PG; Bittar AE; Goldani JC; Pozza R; Bruno RM; See D; Garcia CD; Garcia VD

INSTITUCIÓN / INSTITUTION:  - Renal Transplant Unit, Santa Casa Hospital, Porto Alegre, RS, Brazil. keitel@terra.com.br

 

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[51]

TÍTULO / TITLE:  - Squamous cell carcinoma of the head and neck in solid organ transplant recipients.

REVISTA / JOURNAL:  - Head Neck 2002 Apr;24(4):319-25.

      ●● Enlace al texto completo (gratuito o de pago) 1002/hed.10055 [pii]

AUTORES / AUTHORS:  - Preciado DA; Matas A; Adams GL

INSTITUCIÓN / INSTITUTION:  - Department of Otolaryngology-Head and Neck Surgery, University of Minnesota, Fairview University Medical Center, MMC 396, 420 Delaware Street SE, Minneapolis, MN 55455, USA. preci001@tc.umn.edu

RESUMEN / SUMMARY:  - BACKGROUND: The increased incidence of cancer after solid organ transplantation is well established in the literature, yet outcome studies in this population are rare. Excluding skin cancers, squamous cell carcinomas make up most head and neck cancers in transplant recipients. METHODS: At our institution, of 5300 solid organ transplant recipients, 34 have had head and neck cancer develop. We reviewed the records of the 23 recipients whose cancer was treated here. RESULTS: Only 6 of the 23 recipients were alive at the time of our chart review. Of these, three had already survived 5 years. The 10 recipients diagnosed early (stage I or II) had significantly longer survival after cancer diagnosis than the 13 diagnosed at an advanced stage (stage III or IV) (96.0 mo vs 9.0 mo, p <.001). In all, 14 (60.8%) of the 23 recipients died of cancer within 2 years after diagnosis, 12 (50.2%) within 12 months. The sum of the daily doses of immunosuppressive drugs at cancer diagnosis was significantly greater for recipients who died within 2 years (p =.02). Furthermore, the difference in average doses of both prednisone (p =.001) and azathioprine (p =.028) was also significantly greater for those who died within 2 years. The average dose of cyclosporine was also greater, but this difference did not reach statistical significance (p =.18). The average dose of prednisone was significantly lower for recipients diagnosed early (p =.001). This correlation between high immunosuppressive drug doses and worse outcome has not been shown previously. CONCLUSIONS: Solid organ transplant recipients who are diagnosed with advanced head and neck cancer while receiving high doses of immunosuppressive drugs fare extremely poorly. High doses of immunosuppressive drugs, most notably prednisone, correlate significantly with advanced diagnosis of head and neck cancer and earlier death.  N. Ref:: 30

 

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[52]

TÍTULO / TITLE:  - Stent-based antirestenotic coatings (sirolimus/paclitaxel).

REVISTA / JOURNAL:  - Catheter Cardiovasc Interv 2002 Mar;55(3):404-8.

      ●● Enlace al texto completo (gratuito o de pago) 1002/ccd.10034 [pii]

AUTORES / AUTHORS:  - Oberhoff M; Herdeg C; Baumbach A; Karsch KR

INSTITUCIÓN / INSTITUTION:  - Bristol Heart Institute, University of Bristol, Bristol, U.K. martin.oberhoff@bristol.ac.uk  N. Ref:: 49

 

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[53]

TÍTULO / TITLE:  - Single-agent immunosuppression after liver transplantation: what is possible?

REVISTA / JOURNAL:  - Drugs 2002;62(11):1587-97.

AUTORES / AUTHORS:  - Raimondo ML; Burroughs AK

INSTITUCIÓN / INSTITUTION:  - Liver Transplantation and Hepato-Biliary Medicine, Royal Free Hospital, Hampstead, London, UK.

RESUMEN / SUMMARY:  - Orthotopic liver transplantation is a life saving and life enhancing procedure. The development of immunosuppressive drugs has contributed to the high rate of success in terms of both patient and graft survival. However, the considerable adverse effects of these therapies are affecting long-term outcomes of transplant recipients. Complications related to immunosuppression are responsible for the majority of deaths in patients surviving more than 1 year. Therefore, the search for an optimal immunosuppressive regimen has become of paramount importance. The liver has proved to be an ‘immunologically privileged’ organ, capable in several animal models to be accepted as an allograft without any intervention on the immune system of the recipient. In some human liver allografts acceptance of the new organ is recognised after withdrawal of immunosuppressants, but prior identification of such individuals is not yet possible, thus negating this management option. Graft-recipient interaction is peculiar in liver transplantation: acute cellular rejection does not always need to be treated, and if it is not severe, appears to be associated with a better survival of both patient and graft. In the last decade there has been an evolution of immunosuppressive protocols, driven by empirical observation and a deeper understanding of immunological events after transplant. However, most modifications have been made because of the necessity to reduce long-term drug related morbidity and mortality. Withdrawal of corticosteroids has proven to be safely achievable in most patients, with no deleterious effects on patient or graft survival but with a great benefit in terms of reduction of incidence of metabolic and cardiovascular complications. Long-term ‘steroid-free’ regimens are therefore now widely used. Patients with stable graft function can be easily maintained using a single drug usually after 6 or 12 months and usually with a calcineurin inhibitor. The more evolved step of using monotherapy ab initio has also proven to be effective in a few studies and needs to be explored further. In the future new strategies will be designed to help the development of tolerance of the allograft, selectively stimulating instead of suppressing the immune reaction of the recipient.  N. Ref:: 51

 

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[54]

TÍTULO / TITLE:  - Induction of donor-specific tolerance in rat hind-limb allografts under antilymphocyte serum and cyclosporine A protocol.

REVISTA / JOURNAL:  - J Hand Surg [Am] 2002 Nov;27(6):1095-103.

      ●● Enlace al texto completo (gratuito o de pago) 1053/jhsu.2002.36524

AUTORES / AUTHORS:  - Siemionow M; Oke R; Ozer K; Izycki D; Prajapati R

INSTITUCIÓN / INSTITUTION:  - Department of Plastic Surgery, Microsurgery Research, The Cleveland Clinic Foundation, Cleveland, OH 44195, USA.

RESUMEN / SUMMARY:  - Composite tissue allograft (CTA) transplantation became a clinical reality despite major side effects associated with the administration of chronic immunosuppression. Development of new treatment modalities eliminating life-long immunosuppression is essential for the future of CTA transplantation. In this study, combined use of cyclosporine A (CsA) and antilymphocyte serum (ALS) was tested for the potential to induce tolerance in the rat hind-limb allograft recipients across a major histocompatibility (MHC) barrier (Lewis-Brown-Norway [LBN, RT1(l+n)] to Lewis [LEW, RT1(l)] rats). Thirty transplantations were performed in 5 experimental groups. Animals received CsA and ALS 12 hours before surgery for 21 days thereafter. Although the allograft controls rejected their limbs at day 7 combined treatment of CsA and ALS resulted in indefinite survival (over 420 d) in all allograft recipients. Long-term survivors showed 35% to 42% of donor-specific chimerism in the peripheral blood. Clinical tolerance was confirmed by acceptance of the donor-specific skin grafts and immunocompetence was confirmed by rejection of the third-party grafts. Mixed lymphocyte reaction revealed suppressed response against donor-type antigens and increased response to third-party antigens. Donor-specific tolerance across MHC barrier was induced in CTA allografts under 21 days protocol of ALS/CsA.

 

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[55]

TÍTULO / TITLE:  - Drug-eluting stent: the “magic bullet” for prevention of restenosis?

REVISTA / JOURNAL:  - Basic Res Cardiol 2002 Nov;97(6):417-23.

      ●● Enlace al texto completo (gratuito o de pago) 1007/s00395-002-0379-2

AUTORES / AUTHORS:  - Hehrlein C; Arab A; Bode C

INSTITUCIÓN / INSTITUTION:  - Medizinische Universitatsklinik III, Abt fur Kardiologie und Angiologie, Hugstetterstr 55, 79106 Freiburg i Br, Germany. hehrlein@med1.ukl.uni-freiburg.de

RESUMEN / SUMMARY:  - The need for repeat interventions after initially successful PTCA due to restenosis has been called the “Archilles heel” of a percutaneous revascularization procedure. The incidence of restenosis varies between 20-50 % depending on the stent material, the presence of risk factors, and the location of vascular disease. Some risk factors such as diabetes have been clearly identified, others are currently debated. After years of failures trying to reduces restenosis rates, locally administered antiproliferative means have been shown to successfully inhibit excessive cell growth in response to PTCA. Local radiotherapy of in-stent restenosis results in a reduction of recurrent stenosis versus a conventional PTCA procedure. However, long-term evaluation indicated that restenosis may only be delayed with radiation therapy. Moreover, the restenosis rates were reduced, but the restenotic process was not eliminated. Coronary stents eluting the anti-proliferative agent rapamycin have demonstrated for the first time, that restenosis rates of zero percent are achievable after percutaneous revascularization procedures. Thus, it is intriguing to believe that the elimination of restenosis may have become reality. The purpose of this review is to discuss, whether a stent eluting drugs should be considered as the “magic bullet” for prevention of restenosis after PTCA.  N. Ref:: 88

 

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[56]

TÍTULO / TITLE:  - Sirolimus (Rapamune) in renal transplantation.

REVISTA / JOURNAL:  - Curr Opin Nephrol Hypertens 2002 Nov;11(6):603-7.

      ●● Enlace al texto completo (gratuito o de pago) 1097/01.mnh.0000040045.55337.97

AUTORES / AUTHORS:  - Johnson RW

INSTITUCIÓN / INSTITUTION:  - Manchester Postgraduate Health Sciences Centre, Manchester Royal Infirmary, Manchester.

RESUMEN / SUMMARY:  - There has been a necessary change in attitude to transplantation; there is much less concern with short-term outcome and more concern with long-term kidney function, overall health and quality of life. Nephrotoxicity is an invariable consequence of long-term treatment with calcineurin antagonists and it is one of the most underestimated causes of late graft loss; it has been reported as a serious threat to both patient and graft survival following heart, liver and bone marrow transplantation. Sirolimus has been shown in many recent studies to be of great value in allowing patients to be weaned from cyclosporine with excellent patient and graft survival at 24 months a significant improvement in renal function with resolution of hirsutism and gum hyperplasia. Patients maintained on the combined regime of cyclosporine and sirolimus had significantly higher blood pressure, much more cyclosporine nephrotoxicity and hyperuricaemia at 12 months. The experimental studies have found cyclosporine and sirolimus potentiate with each other’s good and adverse effects. Cyclosporine therefore augments hyperlipidaemia caused by sirolimus, and sirolimus augments nephrotoxicity caused by cyclosporine. The results of these studies indicate that sirolimus is a suitable replacement for cyclosporine or tacrolimus for long-term maintenance therapy. By contrast the use of sirolimus in combination with cyclosporine results in potentiation of side effects. The principal disadvantages being increased cyclosporine associated nephrotoxicity and sirolimus associated hyperlipidaemia  N. Ref:: 32

 

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[57]

TÍTULO / TITLE:  - Polyomavirus BK nephropathy: a (re-)emerging complication in renal transplantation.

REVISTA / JOURNAL:  - Am J Transplant 2002 Jan;2(1):25-30.

AUTORES / AUTHORS:  - Hirsch HH

INSTITUCIÓN / INSTITUTION:  - Department of Internal Medicine, University of Basel, Switzerland. hans.hirsch@unibas.ch

RESUMEN / SUMMARY:  - Persisting polyomavirus replication is now widely recognized as a (re-)emerging cause of renal allograft dysfunction. Up to 5% of renal allograft recipients can be affected about 40weeks (range 6-150) post-transplantation. Progression to irreversible failure of the allograft has been observed in up to 45% of all cases. The BK virus strain is involved in the majority of the cases. Risk factors may include treatment of rejection episodes and increasing viral replication under potent immunosuppressive drugs such as tacrolimus, sirolimus or mycophenolate. The diagnosis requires the histological demonstration of nuclear polyomavirus inclusions in affected tubular epithelial cells. Interstitial inflammatory infiltrates and fibrosis become more prominent in the persisting disease and may be difficult to distinguish from (coexisting) rejection. Detection of polyomavirus-inclusion bearing cells (‘decoy cells’) in the urine and quantification of BK virus DNA in the plasma have been proposed as surrogate markers for polyomavirus replication and allograft disease, respectively. Antiviral treatment is not yet established; however, reports of treatment with cidofovir are encouraging. Current management aims at the judicious modification and/or reduction of immunosuppression which, in view of preceding or concurrent rejection, is not without risk.  N. Ref:: 51

 

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[58]

TÍTULO / TITLE:  - Drug-induced thrombotic microangiopathy: incidence, prevention and management.

REVISTA / JOURNAL:  - Drug Saf. Acceso gratuito al texto completo.

      ●● Enlace a la Editora de la Revista http://www.csmwm.org/ 

      ●● Cita: Drug Safety: <> 2001;24(7):491-501.

AUTORES / AUTHORS:  - Pisoni R; Ruggenenti P; Remuzzi G

INSTITUCIÓN / INSTITUTION:  - Department of Kidney Research, Mario Negri Institute for Pharmacological Research, Bergamo, Italy.

RESUMEN / SUMMARY:  - The term thrombotic microangiopathy (TMA) describes syndromes characterised by microangiopathic haemolytic anaemia, thrombocytopenia and variable signs of organ damage due to platelet thrombi in the microcirculation. In children, infections with Shigella dysenteriae type 1 or particular strains of Escherichia coli are the most common cause of TMA; in adults, a variety of underlying causes have been identified, such as bacterial and viral infections, bone marrow and organ transplantation, pregnancy, immune disorders and certain drugs. Although drug-induced TMA is a rare condition, it causes significant morbidity and mortality. Antineoplastic therapy may induce TMA. Most of the cases reported are associated with mitomycin. TMA has also been associated with cyclosporin, tacrolimus, muromonab-CD3 (OKT3) and other drugs such as interferon, anti-aggregating agents (ticlopidine, clopidogrel) and quinine. The early diagnosis of drug-induced TMA may be vital. Strict monitoring of renal function, urine and blood abnormalities, and arterial pressure has to be performed in patients undergoing therapy with potentially toxic drugs. The drug must be discontinued immediately in the case of suspected TMA. Treatment modalities sometimes effective in other forms of TMA have been used empirically. Although plasma exchange therapy seems to be of value, the effectiveness of this approach has yet to be proved in multicentre, randomised clinical studies.  N. Ref:: 113

 

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[59]

TÍTULO / TITLE:  - Induction versus non-induction protocols in anti-calcineurin-based immunosuppression.

REVISTA / JOURNAL:  - Transplant Proc 2001 Nov-Dec;33(7-8):3334-6.

AUTORES / AUTHORS:  - Charpentier B

INSTITUCIÓN / INSTITUTION:  - Service de Nephrologie, University Hospital of Bicetre, Bicetre, France.

 

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[60]

TÍTULO / TITLE:  - Nephrotoxicity of immunosuppressive drugs: new insight and preventive strategies.

REVISTA / JOURNAL:  - Curr Opin Crit Care 2001 Dec;7(6):384-9.

AUTORES / AUTHORS:  - Olyaei AJ; de Mattos AM; Bennett WM

INSTITUCIÓN / INSTITUTION:  - Division of Nephrology, Hypertension and Clinical Pharmacology, Oregon Health Sciences University and Solid Organ and Cellular Transplantation, Legacy Good Samaritan Hospital, Portland, Oregon 97201, USA. olyaeia@ohsu.edu

RESUMEN / SUMMARY:  - Cyclosporine and tacrolimus reduce allograft rejection, improve allograft half-life and patient survival. Ironically, the nephrotoxicity of these agents may adversely affect allograft survival in renal transplant recipients or cause end-stage renal diseases in other solid organ and bone marrow transplant recipients. Acute dose-dependent and chronic non-dose-dependent nephrotoxicity has been reported in both transplant recipients and patients with autoimmune disorders. Preliminary evidence suggests that drug therapeutic monitoring has little value in the diagnosis or management of nephrotoxicity associated with calcineurin inhibitors. Although the exact mechanism of nephrotoxicity is not fully understood, several factors have been implicated in the pathogenesis of immunosuppressive-induced nephrotoxicity. Renal and systemic vasoconstriction, increased release of endothelin-1, decreased production of nitric acid and increased expression of TGF-beta are the major adverse pathophysiologic abnormalities of these agents. Reducing the dose of a calcineurin inhibitor, or using protocols without calcineurin inhibition may ultimately minimize the risk of drug toxicity and improve allograft and patient survival. New experiences with non-nephrotoxic agents and protocols including mycophenolate and sirolimus allow for early calcineurin inhibitor reduction or elimination without increasing the risk of allograft rejection.  N. Ref:: 55

 

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[61]

TÍTULO / TITLE:  - Rejection-free protocol using sirolimus-tacrolimus combination for pediatric renal transplant recipients.

REVISTA / JOURNAL:  - Transplant Proc 2002 Aug;34(5):1942-3.

AUTORES / AUTHORS:  - El-Sabrout R; Weiss R; Butt F; Delaney V; Qadir M; Hanson P; Butt K

INSTITUCIÓN / INSTITUTION:  - Departments of Transplantation/Vascular Surgery, New York Medical College, Valhalla, New York, USA.

 

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[62]

TÍTULO / TITLE:  - The limitations of calcineurin and mTOR inhibitors: new directions for immunosuppressive strategies.

REVISTA / JOURNAL:  - Transplant Proc 2002 Feb;34(1):130-3.

AUTORES / AUTHORS:  - Kahan BD

INSTITUCIÓN / INSTITUTION:  - Division of Organ Transplantation, Department of Surgery, The University of Texas Medical School, Houston, Texas 77030, USA.  N. Ref:: 76

 

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[63]

TÍTULO / TITLE:  - Can we prevent in-stent restenosis?

REVISTA / JOURNAL:  - Curr Opin Cardiol 2002 Sep;17(5):518-25.

AUTORES / AUTHORS:  - Garza L; Aude YW; Saucedo JF

INSTITUCIÓN / INSTITUTION:  - Division of Cardiovascular Medicine, University of Arkansas for Medical Sciences, Little Rock, 72205, USA. garzaluis@uams.edu

RESUMEN / SUMMARY:  - Nowadays stent placement has replaced balloon angioplasty as the most commonly performed percutaneous coronary interventional procedure, mainly because of its better acute and chronic outcome. As a result, in-stent restenosis (ISR) has become a widespread problem. The incidence of ISR varies from 10% to 50% and depends on the absence or presence of several risk factors, such as small vessel size, longer lesions, and diabetes. Intravascular ultrasound studies have demonstrated that ISR is mainly caused by neointimal proliferation; consequently, this pathologic process has become the target of many preventive and therapeutic approaches. This article provides an overview of such management strategies, highlighting the rather disappointing experiences with mechanical and systemic drug therapies; the relative merits and disadvantages of intracoronary radiation; and the exciting yet realistic promise, embodied by the recent advancements in drug-eluting stent technology, of potentially eradicating ISR in the near future.  N. Ref:: 90

 

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[64]

TÍTULO / TITLE:  - Treatment of transplant rejection: are the traditional immunosuppressants good enough?

REVISTA / JOURNAL:  - Curr Opin Investig Drugs 2001 Mar;2(3):357-63.

AUTORES / AUTHORS:  - Dumont FJ

INSTITUCIÓN / INSTITUTION:  - Department  Immunology & Rheumatology, Merck Research Laboratories, Rahway, NJ 07065, USA. francis_dumont@merck.com

RESUMEN / SUMMARY:  - Due to the improvement in the understanding of the anti-allogenic immune response, the success of transplantation medicine has increased rapidly over the last two decades. The knowledge that the T-lymphocyte played an integral role in transplant rejection, brought cyclosporine A and FK-506 to the fore as therapeutic immunosuppressants. However, the current mainstays in transplant rejection are not without their problems and many drug companies are exploring the possibilities of improving the available therapies by developing drugs with reduced toxicity, improved long-term survival and efficacy against chronic rejection and improved immunosuppressive selectivity. The advances in the understanding of T-cell activation and lymphocyte trafficking has highlighted ways to improve the existing therapies and more selective immunosuppressant targets.  N. Ref:: 60

 

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[65]

TÍTULO / TITLE:  - Place of mycophenolate mofetil in renal transplantation.

REVISTA / JOURNAL:  - Transplant Proc 2001 Feb-Mar;33(1-2):997-9.

AUTORES / AUTHORS:  - Grinyo JM

INSTITUCIÓN / INSTITUTION:  - Hospital de Bellvitge, Barcelona, España.  N. Ref:: 23

 

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[66]

TÍTULO / TITLE:  - Hepatitis C and the incidence of diabetes mellitus after renal transplant: influence of new immunosuppression protocols.

REVISTA / JOURNAL:  - Transplant Proc 2003 Aug;35(5):1748-50.

AUTORES / AUTHORS:  - Gentil MA; Lopez M; Gonzalez-Roncero F; Rodriguez-Algarra G; Pereira P; Lopez R; Martinez M; Toro J; Mateos J

INSTITUCIÓN / INSTITUTION:  - Servicio de Nefrologia, Hospital Universitario Virgen del Rocio, Sevilla, España.

RESUMEN / SUMMARY:  - BACKGROUND: Hepatitis C has been associated with an increased incidence of diabetes mellitus (DM) following renal transplantation (RT). METHODS: Patients who underwent RT between 1985 and 2001 were excluded if they showed DM prior to RT, graft survival of less than 90 days, and unknown anti-HCV status (n=15). Two groups (G1 and G2) were distinguished according to the immunosuppressive regimen: G1 (transplanted 1985-1996) received steroids, azathioprine, and cyclosporine (n=330), whereas G2 (1997-2000) received new drugs in several combinations (MMF in 87% and/or tacrolimus in 35% [n=240]). Patients with HCV antibodies pre- and/or post-RT were considered HCV-positive. Post-RT DM requiring prolonged treatment with oral antidiabetics or insulin (>1 month) was assessed using Kaplan-Meier curves and Cox analysis. RESULTS: G2 patients were significantly older, had a greater body mass index (BMI), and suffered significantly less from acute rejection episodes during the first year than G1 patients. Furthermore, fewer required maintenance steroids. HCV-positivity was more common in G1 than in G2 (n=96, 29.1% vs n=27, 11.3%). Six G2 patients were successfully treated with interferon pre-RT, achieving negative PCR-HCV status (maintained post-RT). DM incidence at 4 years was similar in G1 and G2 (8.8% and 8.2%). G1 HCV-positive patients showed a greater risk of developing DM than HCV-negative patients (28.0% vs 6.2% at 10 years; P=001). In G1, multivariate analysis showed that age, BMI, and HCV-positivity were significant risk factors predicting DM (relative risk, 5.7; 95% confidence interval 2.7-12). In G2 patients, HCV was not associated with an increased risk of DM; in the multivariate analysis only age appeared to be a risk factor. CONCLUSIONS: The reported relationship between hepatitis C and post-RT DM was not observed among patients receiving new immunosuppressive treatments. Confirmation of this finding requires extended follow up. The reduced use of steroids and effective pre-RT use of interferon may also be responsible for the benefit.

 

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[67]

TÍTULO / TITLE:  - Pediatric heart transplantation.

REVISTA / JOURNAL:  - Curr Opin Pediatr 2002 Oct;14(5):611-9.

AUTORES / AUTHORS:  - Boucek Jr RJ; Boucek MM

INSTITUCIÓN / INSTITUTION:  - All Children’s Hospital, University of South Florida, St. Petersburg, Florida, 33701, USA. boucekr@allkids.org

RESUMEN / SUMMARY:  - Heart transplantation is now a treatment option with good outcome for infants and children with end-stage heart failure or complex, inoperable congenital cardiac defects. One-year and 5-year actuarial survival rates are high, approximately 75% and 65%, respectively, with overall patient survival half-life greater than 10 years. To date, survival has been improving as a result of reducing early mortality. Further reductions in late mortality, in part because of graft coronary artery disease and rejection, will allow achievement of the goal of decades-long survival. Quality of life in surviving children, as judged by activity, is usually “normal.” Somatic growth is usually at the low normal range but linear growth can be reduced. Of infant recipients, 85% evaluated at 6 years of age or older were in an age-appropriate grade level. Long-term management of childhood heart recipients requires the collaboration of transplant physicians, given the increasing number of immunosuppressive agents and the balance between rejection and infection. Currently, recipients are maintained on immunosuppressive medications that target calcineurin (eg, cyclosporine, tacrolimus), lymphocyte proliferation (eg, azathioprine, mycophenolate mofetil [MMF], sirolimus) and, in some instances antiinflammatory corticosteroids. Emerging evidence now suggests a favorable immunologic opportunity for transplantation in childhood and, conversely, a higher mortality rate in children who have had prior cardiac surgery. Further studies are needed to define age-dependent factors that are likely to play a role in graft survival and possible graft-specific tolerance (eg, optimal conditions for tolerance induction and how immunosuppressive regimens should be changed with maturation of the immune system). As late outcomes continue to improve, the need for donor organs likely will increase, as transplantation affords a better quality and duration of life for children with complex congenital heart disease, otherwise facing a future of multiple palliative operations and chronic heart failure.  N. Ref:: 63

 

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[68]

TÍTULO / TITLE:  - Everolimus. Novartis.

REVISTA / JOURNAL:  - Curr Opin Investig Drugs 2001 Sep;2(9):1220-34.

AUTORES / AUTHORS:  - Dumont FJ

INSTITUCIÓN / INSTITUTION:  - Merck Research Laboratories, Department of Immunology & Rheumatology, 126 East Lincoln Avenue, PO Box 2000, Rahway, NJ 07065, USA. francis_dumont@merck.com

RESUMEN / SUMMARY:  - Everolimus (RAD-001, SDZ RAD, Certican), an analog of sirolimus, is an oral immunosuppressant that inhibits growth factor-induced cell proliferation, under development by Novartis as a potential treatment for transplant rejection. Phase III trials were initiated by the end of 1998 [319337] and were ongoing in February 2001 [400448]. At the end of 2000, Novartis was hoping to file for approval of the compound in 2001 [392881], with a possible launch in mild-2002 [392881], [401979]. Completion of phase III trials in heart transplant patients is expected this year and lung and liver transplants by 2003. In 1999, American Home Products (AHP) initiated an action for infringement of the patent EP-00401747, which covers the use of sirolimus in transplantation in the UK, the Netherlands and Germany, seeking to restrain the clinical trial program for everolimus. Novartis subsequently filed a counterclaim for invalidity. In December 1999, the UK High Court of Justice ruled that everolimus infringes the British counterpart of EP-00401747 [349637]. In contrast, in April 2000, the District Court of The Hague ruled that everolimus does not infringe patent rights licensed to AHP [362823] and in July 2000, The Court of Appeal in the UK came to the same conclusion [376559]. In February 2001, the Opposition Board at the European Patent Office upheld Novartis’ European patent for everolimus, which the Board held to be ‘inventive’ [400448]. In July 2000, Vontobel estimated sales of SFr 80 million in 2002, rising to SFr 800 million in 2004 [378871]. In February 2001, Merrill Lynch predicted sales of SFr 125 million rising to SFr 661 million in 2005 [411704].  N. Ref:: 100

 

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[69]

TÍTULO / TITLE:  - Central pontine myelinolysis.

REVISTA / JOURNAL:  - Eur Neurol 2002;47(1):3-10.

AUTORES / AUTHORS:  - Lampl C; Yazdi K

INSTITUCIÓN / INSTITUTION:  - Department of Neurology, Psychiatry and Pain Clinic, General Hospital Linz, Austria. christian.lampl@akh.linz.at

RESUMEN / SUMMARY:  - Central pontine myelinolysis (CPM) is a demyelinating disease of the pons often associated with demyelination of other areas of the central nervous system (CNS). The term ‘osmotic demyelinization syndrome’ is used for pontine and extrapontine myelinolysis. In this paper, we are concerned with CPM although the extrapontine one is based on the same pathogenesis. Both share the diagnostic methods, and their prevention and therapy are the same. The etiology and pathogenesis of this disorder are unclear and will be discussed. However, almost all cases of CPM are related to severe diseases. Chronic alcoholism is still the most common underlying condition of CPM patients. In the literature, 174 cases of CPM have been reported in alcoholics since 1986, which is equivalent to an incidence of 39.4%. Likewise, 95 cases of CPM following the correction of hyponatremia have been documented since 1986 (21.5%). The role of hyponatremia and its correction will be outlined in the discussion of the pathogenesis of CPM. The third largest group of CPM cases are liver transplant patients (17.4%), with the development of CPM being attributed to the immunosuppressive agent cyclosporine in particular. Depending on the involvement of other CNS structures, the clinical picture can vary considerably. The large-scale introduction of magnetic resonance imaging has increasingly facilitated the antemortem diagnosis of CPM, although the radiological findings lag behind and do not necessarily correlate with the clinical picture. As yet, there is no specific therapy of choice. A number of therapeutic approaches have been tested and although they have not been compared with regard to their rate of success, they have all led to a substantial improvement in the prognosis of CPM.  N. Ref:: 74

 

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[70]

TÍTULO / TITLE:  - Adverse gastrointestinal effects of mycophenolate mofetil: aetiology, incidence and management.

REVISTA / JOURNAL:  - Drug Saf. Acceso gratuito al texto completo.

      ●● Enlace a la Editora de la Revista http://www.csmwm.org/ 

      ●● Cita: Drug Safety: <> 2001;24(9):645-63.

AUTORES / AUTHORS:  - Behrend M

INSTITUCIÓN / INSTITUTION:  - Abteilung fur Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover, Hannover, Germany. Behrend.Matthias@MH-Hannover.de

RESUMEN / SUMMARY:  - Mycophenolate mofetil (MMF) is a relatively new immunosuppressive drug. It inhibits inosine monophosphate dehydrogenase, a key enzyme in the de novo pathway of purine synthesis, and thus causes lymphocyte-selective immunosuppression. Large clinical trials have revealed the efficacy of MMF in the prevention of allograft rejection when administered together with cyclosporin or tacrolimus and corticosteroids. Although the adverse effect profile of MMF is comparatively benign, gastrointestinal adverse effects are a major concern. These effects are partially explained by the increased immune suppression, by the mode of action and by interactions, particularly with other immunosuppressants. The aetiology of the rarest gastrointestinal adverse effects is still not completely clear. Therapy depends upon the clinical gravity of the adverse effects and is therefore a case of waiting and ob- serving. An adjustment of dosage of immunosuppressants according to the clinical situation and, particularly in the case of MMF, spreading the total dosage over more than 2 daily doses are often sufficient. Should adverse effects persist for a longer period of time and be of a more serious nature, a comprehensive invasive diagnostic process is necessary, including endoscopy and biopsy and the search for opportunistic infections. In this case, dosage reduction or the complete withdrawal of MMF seems to be unavoidable. Severe gastrointestinal complications with MMF are rare, but when they do occur they may require extensive diagnosis and treatment. In the future, therapeutic drug monitoring and, where necessary, pharmacological modifications of MMF could lead to a further reduction of adverse effects with an equal or even increased efficacy.  N. Ref:: 115

 

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[71]

TÍTULO / TITLE:  - Antiproliferative coatings for the treatment of coronary heart disease:. what are the targets and which are the tools?

REVISTA / JOURNAL:  - J Interv Cardiol 2003 Dec;16(6):475-83.

AUTORES / AUTHORS:  - Smith EJ; Rothman MT

INSTITUCIÓN / INSTITUTION:  - London Chest Hospital, Barts and the London NHS Trust, London, UK.

RESUMEN / SUMMARY:  - Since the advent of percutaneous coronary intervention (PCI) for stenosing coronary disease, restenosis has remained a clinical problem. Despite the emergence and evolution of coronary stents, the rate of restenosis following PCI is still 10-20%, and above 50% in high risk subgroups. With increased understanding of the pathophysiology of this process, a number of potential therapeutic targets have been identified, allowing the development of novel therapies against restenosis, which can now be delivered locally using stent platforms. Some of the reported clinical trial data utilizing drug-eluting stents (DES) have produced such profound reductions in clinical and angiographic restenosis that we have been tempted to believe we are on the brink of eradicating this process completely. As the initial excitement subsides, however, there is a need to decide whether these tools will remain effective in real-world interventional practice. In this article we review the pathophysiology of the restenotic process, and the biological targets of the DES therapies currently available in clinical practice. We attempt to define clinical target populations for DES therapy, and assess the impact on outcomes thus far. We consider the advantages that newly emergent stent coatings might offer, and whether targeting specific patient subgroups with unique antiproliferative agents may provide the best chance of limiting restenosis in high risk subgroups. Finally, we consider future strategies to prevent restenosis, with a movement away from the antiproliferative approach, and toward accelerating endothelialization.  N. Ref:: 41

 

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[72]

TÍTULO / TITLE:  - Pregnancy associated aplastic anemia—a series of 10 cases with review of literature.

REVISTA / JOURNAL:  - Hematology 2002 Aug;7(4):233-8.

      ●● Enlace al texto completo (gratuito o de pago) 1080/1024533021000024067

AUTORES / AUTHORS:  - Choudhry VP; Gupta S; Gupta M; Kashyap R; Saxena R

INSTITUCIÓN / INSTITUTION:  - Department of Hematology, All India Institute of Medical Sciences, New Delhi 110029, India. vedpchoudhry@yahoo.co.in

RESUMEN / SUMMARY:  - Introduction: Pregnancy induced aplastic anemia is a rare entity and the association is not well explained. There are approximately 80 cases in the literature and we are presenting the largest series, so far, of 10 cases.Results: Total of 10 cases had 11 pregnancies. Mean age at presentation was 25.45 years and mean gestation when symptoms first developed was 17.09 weeks. Pallor and bleeding manifestations were the most common presenting complaints. Mean Hb, TLC, ANC and platelets were 4.97 g/dl, 2.74 x 10(9)/l, 1.11 x 10(9)/l and 41 x 10(9)/l, respectively. Bone biopsy cellularity ranged from <5 to 25%. Nine out of 11 (81%) pregnancies were successful of which 7 was full term and 2 were premature. Two babies were small for dates. One spontaneous abortion and one intra uterine death (IUD) were observed. Two out of 11 mothers died due to disease after delivery. Two of the 8 surviving mothers, had spontaneous partial response (22%); 4 mothers were asymptomatic after therapy with immunosuppressives given for 6 months and 3 were lost to follow up without response. Specific therapy (cyclosporin) was tried in two mothers antenatally with partial response in one. One child whose mother was given cyclosporin antenatally had jejunal atresia at birth.Conclusion: Pregnancy associated aplastic anemia is a rare association. Spontaneous remission can occur in 25-30% of patients. In the first trimester patients, pregnancy can be terminated while in advanced pregnancy patients can be followed up with stringent supportive care. Cyclosporin may be a safe drug antenatally in such patients. Patients with established aplastic anemia should avoid pregnancy.  N. Ref:: 23

 

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[73]

TÍTULO / TITLE:  - Prevention and treatment of severe hemodynamic compromise in pediatric heart transplant patients.

REVISTA / JOURNAL:  - Paediatr Drugs 2002;4(11):705-15.

AUTORES / AUTHORS:  - Costello JM; Pahl E

INSTITUCIÓN / INSTITUTION:  - Division of Pulmonary and Critical Care Medicine, Department of Pediatrics, The Children’s Memorial Hospital, Feinberg School of Medicine at Northwestern University, Chicago, Illinois 60614, USA.

RESUMEN / SUMMARY:  - Allograft rejection is a leading cause of severe hemodynamic compromise in pediatric heart transplant patients. A triple-drug immunosuppression regimen, which includes a calcineurin inhibitor, antiproliferative agent, and corticosteroid, suppresses the immune system at multiple different levels for optimal graft protection while minimizing the adverse effects of any one particular agent. Some pediatric centers also use induction therapy with anti-T cell antibodies immediately following transplantation as additional rejection prophylaxis. These antibodies augment immunosuppression by either depleting the T cell pool or blocking interleukin-2 receptors on activated T cells. Despite the aggressive preventive measures outlined above, some pediatric heart transplant patients will develop severe hemodynamic compromise, most commonly due to fulminant rejection. Such patients require attention to, and optimization of, the four determinants of cardiac output (heart rate, preload, contractility and afterload) to stabilize the circulation until the rejection can be reversed. Careful administration of volume, diuretics, inotropes, and afterload-reducing agents will meet this goal. Patients with allograft rejection require augmentation of immune suppression to facilitate myocardial recovery. Corticosteroids form the cornerstone of treatment for both cellular and vascular rejection. In patients with refractory cellular rejection, conversion to mycophenolate mofetil or tacrolimus may be appropriate if these agents are not already being used for maintenance immunosuppression. Critically ill patients may additionally benefit from muromonab-CD3 (OKT3) to augment lympholysis. Treatment employed specifically for humoral rejection is prescribed with the intention of suppressing new antibody formation, removing circulating antibody, and improving coronary blood flow. In addition to corticosteroids, cyclophosphamide and antithymocyte globulin or muromonab-CD3, along with plasmapheresis, may improve survival. Systemic heparinization should be considered to minimize coronary thrombosis in patients with humoral rejection. In the future, novel immunosuppressive agents may further assist in the prevention as well as treatment of severe hemodynamic compromise due to rejection in pediatric heart transplant recipients.  N. Ref:: 99

 

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[74]

TÍTULO / TITLE:  - Treatment of bifurcation coronary lesions: a review of current techniques and outcome.

REVISTA / JOURNAL:  - J Interv Cardiol 2003 Dec;16(6):507-13.

AUTORES / AUTHORS:  - Melikian N; Di Mario C

RESUMEN / SUMMARY:  - Percutaneous treatment of coronary bifurcation lesions, pose a number of technical challenges to the interventional cardiologist. Each lesion has to be approached with its own, targeted solution in the context of the clinical picture, anatomy, and pathology. To achieve acceptable clinical outcomes a number of established techniques are available. The exact anatomy of the lesion determines the technique used. The most common approach is to stent the main vessel across the ostium of the side branch. The side branch can be additionally treated with a second stent or balloon angioplasty depending on the severity of the ostial lesion and/or evidence of active ischemia. Other techniques involve stenting the main branch up to the carina but sparing the side branches, multiple ‘kissing stent’ approaches (‘Y’,’T’, and ‘V’) or the ‘culottes’ technique. Follow-up data demonstrates a high (over 90%) technical success rate. Clinical outcome is variable but with conventional stents restenosis rates higher than 30% have been reported in most studies and there is no added advantage in routine stenting of both main vessel and side branch. Recent introduction of drug-eluting stents has resulted in a lower event rate and reduction of main vessel restenosis in comparison with historical controls. Side branch ostial restenosis remains a problem, which may require the development of novel ‘bifurcate’ stent designs to allow complete coverage with a single stent.  N. Ref:: 36

 

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[75]

TÍTULO / TITLE:  - New developments in the prophylaxis and treatment of graft versus host disease.

REVISTA / JOURNAL:  - Expert Opin Pharmacother 2001 Jul;2(7):1109-17.

AUTORES / AUTHORS:  - Simpson D

INSTITUCIÓN / INSTITUTION:  - North Shore Hospital, Auckland, New Zealand. david.simpson@whl.co.nz

RESUMEN / SUMMARY:  - Graft versus host disease (GVHD) remains the major obstacle to successful allogeneic bone marrow transplantation. Cyclosporin with methotrexate is the most common prophylactic regimen. Tacrolimus is associated with less GVHD and is gaining ground especially in unrelated donor transplants where current regimens are unsatisfactory. Mycophenolate mofetil (MMF) and rapamycin have not yet shown benefit in acute GVHD prophylaxis. In vivo T-cell depletion with Campath 1H or thymoglobulin used during transplant conditioning are increasingly used in place of ex vivo T-cell depletion, where results remain disappointing. Steroids remain first choice for therapy of GVHD but anti-CD25 antibodies, daclizumab or basiliximab are gaining popularity as second-line therapy ahead of ATG. Chronic GVHD is increasing with greater use of peripheral blood stem cell grafts and older patients. The combination of tacrolimus and MMF is promising for patients with extensive disease. Tolerance induction using CTLA-4-Ig, anti-CD40L, tresperimus and/or rapamycin may revolutionise GVHD therapy. However, due to the desirability of tumour intolerance, tolerance is likely to be developed in organ transplantation before bone marrow transplantation for traditional indications. Bone marrow transplants performed to induce organ tolerance may see increasing use of these agents. TNF blockade using infliximab or etanercept (Enbrel) is promising but the role of these agents is not yet defined.  N. Ref:: 68

 

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[76]

TÍTULO / TITLE:  - Heat shock proteins: novel therapeutic tools for HIV-infection?

REVISTA / JOURNAL:  - Expert Opin Biol Ther 2001 Jan;1(1):67-77.

AUTORES / AUTHORS:  - Brenner BG; Wainberg Z

INSTITUCIÓN / INSTITUTION:  - McGill University, Montreal, Quebec, Canada. bbrenn1@po-box.mcgill.ca

RESUMEN / SUMMARY:  - Heat shock proteins (Hsps), cyclophilins (Cyps) and FK binding proteins (FKBPs) form a family of intracellular chaperone molecules that facilitate protein folding and assembly. These stress proteins are selectively expressed in cells in response to a range of stimuli, including heat, lymphokine and microbial/viral infections. This review discusses the role of stress proteins in the HIV-1 viral life cycle, with regard to the development of specific Hsp-based therapeutic strategies against HIV-1 infection. Cumulative findings are cited implicating CypA, Hsp27, Hsp70 and FKBPs in host cell and viral activation, viral entry, assembly or formation of infectious virions. Biological response modifiers that show specific high-affinity interactions with Cyp, FKBPs and Hsps, including cyclosporins, FK-506 and cyclopentenone prostaglandins respectively, may block HIV-1 replication and infection, providing novel HIV-1 therapeutic strategies. Moreover, Hsp binding to viral complexes can enhance antiviral immunity, including natural killer (NK), antibody-dependent (ADCC), gamma delta T-cell and cytotoxic T-lymphocyte (CTL) activities against HIV-1 infected cells. The ability of Hsps to interact with HIV-1 viral proteins, combined with their inherent adjuvant and immunogenic properties indicates that Hsps may also serve as vehicles for antigen delivery and the design of AIDS vaccines.  N. Ref:: 94

 

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[77]

TÍTULO / TITLE:  - Strategies for minimizing hyperlipidemia after cardiac transplantation.

REVISTA / JOURNAL:  - Am J Cardiovasc Drugs 2002;2(6):377-87.

AUTORES / AUTHORS:  - Kirklin JK; Benza RL; Rayburn BK; McGiffin DC

INSTITUCIÓN / INSTITUTION:  - Department of Surgery, Division of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, Alabama 35294, USA. jkirklin@uab.edu

RESUMEN / SUMMARY:  - Allograft coronary artery disease represents a major limitation to long-term survival after cardiac transplantation. Hyperlipidemias have been linked to the development of native coronary atherosclerosis, and hyperlipidemic states have correlated with the severity of allograft coronary artery disease. Heart transplant recipients typically manifest increases in plasma levels of total cholesterol, low-density lipoprotein-cholesterol (LDL-C), and triglycerides within the first 3-12 months following transplantation. Factors known to promote post-transplant hyperlipidemia include the use of corticosteroids, cyclosporine (interference with clearance and increased oxidizability of LDL), sirolimus (hypertriglyceridemia), and patient-specific causes of hyperlipidemia which contributed to their underlying heart disease. Hydroxymethylglutaryl coenzyme-A (HMG-CoA) reductase inhibitors are the foundation of antilipid therapy following cardiac transplantation. Pravastatin is effective in lowering plasma cholesterol levels and is associated with a decreased incidence and progression of allograft coronary artery disease. All HMG-CoA reductase inhibitors except pravastatin are metabolized by the hepatic cytochrome P450 system which metabolizes cyclosporine, increasing the risk of myostitis when they are used in large dosages with cyclosporine. Simvastatin, atorvastatin and fluvastatin have been studied in heart transplant recipients. Gemfibrozil has proved effective in transplant recipients when there is isolated marked elevation of plasma triglyceride levels. When hyperlipidemia persists despite therapy, some benefit may result with conversion from cyclosporine to tacrolimus. Although a definitive link between hyperlipidemia and allograft coronary disease has yet to be proven, available evidence points to abnormal lipid metabolism as part of the complex etiologic machinery driving the process of ‘chronic rejection’. Consensus exists within the transplant community that a HMG-CoA reductase inhibitor such as pravastatin, should be part of the routine post-transplant drug regimen, and persistent hyperlipidemia should be aggressively treated.  N. Ref:: 83

 

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[78]

TÍTULO / TITLE:  - Tresperimus: a new agent for transplant tolerance induction.

REVISTA / JOURNAL:  - Expert Opin Investig Drugs 2001 Jul;10(7):1381-6.

AUTORES / AUTHORS:  - Simpson D

INSTITUCIÓN / INSTITUTION:  - North Shore Hospital, Private Bag 93-503, Takapuna, Auckland, New Zealand. david.simpson@whl.co.nz

RESUMEN / SUMMARY:  - Tresperimus is a novel agent that induces allogeneic transplant tolerance. It is structurally related to deoxyspergualin (DSG) but has been modified to resist rapid hydrolysis in aqueous solution, which simplifies administration. Despite this modification, tresperimus’s actions in experimental models seem almost identical to DSG. Initially, DSG was developed as an antitumour agent. Its antitumour efficacy appears limited but DSG and tresperimus have favourable effects on transplant rejection. A short course of tresperimus has been shown to have similar or greater quantitative effects to cyclosporin in bone marrow, cardiac and skin transplant models. However, qualitatively the effects are different. Prevention of rejection is due to induction of donor-specific tolerance without affecting immunity to third party antigens. In addition, CD4+ T-cells from tresperimus-treated animals can transfer donor specific tolerance to naive animals, an effect not seen with cyclosporin or other traditional immunosuppressive drugs. The mechanism by which tolerance is induced is not clear. Tresperimus (like DSG) binds to Hsc70, which among other effects inhibits nuclear localisation of NF-kappa B. NF-kappa B nuclear localisation is induced by CD40 ligation in antigen-presenting cells, an important early step in T-cell co-stimulation. NF-kappa B is also required for CD28 ligation signalling, important in late co-stimulation. It also is involved in B-cell activation, via CD40 ligation and kappa light chain production. Hsc70 is also required for efficient cytosolic peptide chaperoning to MHC class I molecules. Presumably, it is disruption of T-cell/dendritic cell interaction that leads to induction of T-cell anergy. Tresperimus is well-tolerated. The main dose limiting side effects are orthostatic hypotension and peri-oral numbness. These effects are dependant on blood drug levels and, due to its short half-life, correspond to the rate of infusion. Phase II/III clinical studies are accruing patients and results have not yet been reported. Tresperimus shows promise in the move from immunosuppression to tolerance induction as the way to prevent transplant rejection and graft versus host disease (G v HD). However, its role in tolerance induction and effect in combination with other tolerance inducing agents e.g., CTLA-4-Ig and anti-CD40L antibodies remains unclear.  N. Ref:: 36

 

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[79]

TÍTULO / TITLE:  - Post-transplant diabetes: incidence, relationship to choice of immunosuppressive drugs, and treatment protocol.

REVISTA / JOURNAL:  - Adv Ren Replace Ther 2001 Jan;8(1):64-9.

AUTORES / AUTHORS:  - Markell MS

INSTITUCIÓN / INSTITUTION:  - Division of Transplant Nephrology, State University of New York, Downstate Medical Center, Brooklyn, NY 11203, USA. mmarkell@hscbklyn.edu

RESUMEN / SUMMARY:  - Post-transplant diabetes mellitus (PTDM) is one of the feared complications of immunosuppressive therapy. Despite advances, including the introduction of the steroid-sparing calcineurin inhibitors, cyclosporine and tacrolimus, the incidence rate remains greater than 10% to 30%, especially in minority populations. PTDM increases the subsequent risk of both graft loss and patient death, and predisposes patients to all complications of diabetes, including retinopathy and neuropathy. Patients should be monitored closely, especially during the first 3 months post-transplant, and treated aggressively, should glucose intolerance be detected. Minimization of immunosuppression dose, diet, oral hypoglycemic agents, and insulin have all been used in the treatment of PTDM, however, the insulin-sensitizing agents have not been studied. It is hoped that newer immunosuppressive regimens and, ultimately, the ability to achieve tolerance will eventually solve the problem of PTDM.  N. Ref:: 53

 

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[80]

TÍTULO / TITLE:  - Sirolimus: a comprehensive review.

REVISTA / JOURNAL:  - Expert Opin Pharmacother 2001 Nov;2(11):1903-17.

AUTORES / AUTHORS:  - Kahan BD

INSTITUCIÓN / INSTITUTION:  - Division of Immunology and Organ Transplantation, University of Texas-Houston, 6431 Fannin, Suite 6.240, Houston, TX 77030, USA. barry.d.kahan@uth.tmc.edu

RESUMEN / SUMMARY:  - Sirolimus (Rapamune), Wyeth-Ayerst, Madison, NJ) is a new, potent, immunosuppressant that is emerging as a foundation for long-term immunosuppressive therapy in renal transplantation. The drug acts during both co-stimulatory activation and cytokine-driven pathways via a unique mechanism: inhibition of a multifunctional serine-threonine kinase, mammalian target of rapamycin (mTOR). Although there is no a priori reason to assume it, sirolimus displays a synergistic interaction to enhance the efficacy of cyclosporin A (CsA). In trials wherein the concentrations of CsA and sirolimus were tightly controlled, rates of acute rejection episodes were < 10%, despite markedly reduced exposures to each agent. In pivotal multi-centre blinded dose-controlled trials, the rates of acute rejection episodes within 12 months following administration of 2 or 5 mg/day sirolimus in combination with CsA and steroids were reduced to 19 and 14%, respectively. Since the inhibitory effect of sirolimus disables virtually all responses to cytokine mediators due to the widespread involvement of mTOR in multiple signalling pathways, the agent is likely also to retard proliferation of endothelial and vascular smooth muscle cells, an important component of the immuno-obliterative processes associated with chronic rejection. The advantages of this unique therapeutic action combined with an intrinsic lack of nephrotoxicity are counterbalanced by myelosuppressive and hyperlipidaemic side effects. Ongoing studies are assessing whether the long-term benefits of sirolimus to permit reduction in exposure to or elimination of calcineurin inhibitors ameliorate the progression of chronic nephropathy, the condition that erodes long-term renal transplant survival.  N. Ref:: 108

 

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[81]

TÍTULO / TITLE:  - New developments in immunosuppressive therapy in renal transplantation.

REVISTA / JOURNAL:  - Expert Opin Biol Ther 2002 Jun;2(5):483-501.

AUTORES / AUTHORS:  - Gourishankar S; Turner P; Halloran P

INSTITUCIÓN / INSTITUTION:  - Division of Nephrology and Immunology, University of Alberta, Edmonton, Canada. gsita@hotmail.com

RESUMEN / SUMMARY:  - The introduction of new immunosuppressive agents and protocols has improved outcomes for renal transplant recipients by decreasing the risk of rejection and by increasing the function and lifespan of the allograft. This article reviews the major changes in the combinations of therapies used: calcineurin inhibitors, target of rapamycin inhibitors, mycophenolate mofetil, non-depleting monoclonal versus depleting monoclonal and polyclonal antibodies for induction and increasing emphasis on protocols for reduction or avoidance of steroids and calcineurin inhibitors. The new agents with novel immunological targets such as anti-CD40 ligand, LEA29Y, FTY720, anti-CD20 (rituximab, Rituxan, Mabthera) and anti-CH52 (alemtuzumab, Campath), which are under development but have yet to survive the rigors of clinical trials are also discussed. In the presence of low early rejection rates, immunosuppressive therapy is setting new goals such as better graft function (glomerular filtration rates), reduction in adverse effects such as hypertension, hyperlipidaemia and drug toxicity and, above all, the prevention of late graft deterioration.  N. Ref:: 156

 

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[82]

TÍTULO / TITLE:  - Synergy of passive coating and targeted drug delivery: the tacrolimus-eluting Janus CarboStent.

REVISTA / JOURNAL:  - J Interv Cardiol 2003 Dec;16(6):499-505.

AUTORES / AUTHORS:  - Bartorelli AL; Trabattoni D; Fabbiocchi F; Montorsi P; de Martini S; Calligaris G; Teruzzi G; Galli S; Ravagnani P

INSTITUCIÓN / INSTITUTION:  - Centro Cardiologico Monzino IRCCS, Institute of Cardiology, University of Milan, Milan, Italy. albartorelli@cardiologicomonzino.it

RESUMEN / SUMMARY:  - Stents represent a major step forward in the treatment of coronary artery disease since the introduction of balloon angioplasty. They have demonstrated the reduction of angiographic indexes of restenosis and rates of repeat revascularization. However, in-stent neointimal proliferation represents the persisting limitation and challenge. Local delivery using a stent platform for deposition of therapeutic drug concentration in the arterial wall has emerged as an effective strategy to reduce in-stent neointimal hyperplasia and restenosis. The purpose of this article is to describe the design characteristics of a new drug-eluting stent. Its unique features consist of integral Carbofilm thromboresistant coating combined with the capability to load the drug into and to release it from deep sculptures made on the external surface of the stent. The advantages of this design are the possibility to load higher amounts of drug, to selectively deliver it to the vessel wall without loss in the blood stream, and to improve the biocompatibility and thromboresistance of the stent. Preclinical studies, using tacrolimus as the biological agent, showed excellent vessel tissue response and mild inflammation scores. A significant reduction of intimal proliferation was observed in comparison with a control stent. The enrollment in a safety first-in-man evaluation has been successfully completed. A randomized, double-blind, multicenter study is expected to start at the completion of the “safety” evaluation.  N. Ref:: 31

 

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[83]

TÍTULO / TITLE:  - Use of sirolimus in kidney transplantation.

REVISTA / JOURNAL:  - Prog Transplant 2001 Mar;11(1):29-32.

AUTORES / AUTHORS:  - Podbielski J; Schoenberg L

INSTITUCIÓN / INSTITUTION:  - University of Texas Medical School at Houston, Houston, Tex., USA.

RESUMEN / SUMMARY:  - Sirolimus, which has a distinctive mechanism of action that inhibits cytokine-driven cell proliferation and maturation, provides an exciting addition to the immunosuppressive regimen for organ transplantation. A significant decrease in the number and severity of rejection episodes has been noted when sirolimus is used; it also offers the potential for patients to be withdrawn from steroids, making kidney transplantation an option for many more potential recipients. Toxic conditions such as hyperlipidemia, thrombocytopenia, and leukopenia become transient and manageable with reduction of the sirolimus dose and/or countermeasure therapy.  N. Ref:: 9

 

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[84]

TÍTULO / TITLE:  - Sirolimus-eluting stents: a review of experimental and clinical findings.

REVISTA / JOURNAL:  - Z Kardiol 2002;91 Suppl 3:49-57.

AUTORES / AUTHORS:  - Toutouzas K; Di Mario C; Falotico R; Takagi T; Stankovic G; Albiero R; Corvaja N; Colombo A

INSTITUCIÓN / INSTITUTION:  - Department of Interventional Cardiology, Centro Cuore Columbus Via M. Buonarroti, 48 20145 Milan, Italy.

RESUMEN / SUMMARY:  - Sirolimus (rapamycin), a macrolide antibiotic with known potent immunosuppressive properties, acts in the first phase (G1) of the cell cycle, blocking its further progression to the phase of DNA synthesis (S). In experimental models, rapamycin is effective in inhibiting smooth muscle cell proliferation and migration after vessel wall injury with balloon angioplasty. These results lead to the clinical application of sirolimus-eluting stents in 45 patients in Sao Paulo and Rotterdam (FIM Registry) and 238 patients in a randomized, European multicenter trial (RAVEL). These trials showed, by angiography and intravascular ultrasound, almost complete abolition of in-stent late hyperplasia up to one year after the procedure. In this review, we describe the experimental and clinical results of sirolimus-eluting stents including our experience of 26 stents implanted in 17 patients. In elective de novo lesions has shown remarkably clear lumens at follow-up angiography and intravascular ultrasound within the stented segments were observed with no lesion progression at the stent margins or thrombosis after a 2 month regimen of aspirin, and ticlopodine or clopidogrel. New large-scale ongoing clinical trials will investigate the efficacy of sirolimus-eluting stents in lesions that are traditionally associated with high restenosis rates after stent implantation, such as long lesions, bifurcations and instent restenosis.  N. Ref:: 34

 

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[85]

TÍTULO / TITLE:  - Immunosuppressive effects of beta-herpesviruses.

REVISTA / JOURNAL:  - Herpes 2003 May;10(1):12-6.

AUTORES / AUTHORS:  - Boeckh M; Nichols WG

INSTITUCIÓN / INSTITUTION:  - Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA. mboeckh@fhcrc.org

RESUMEN / SUMMARY:  - Immunomodulatory effects of human beta-herpesviruses have been reported in vitro and in vivo. Clinical studies suggest that beta-herpesvirus infection may increase the risk for other infections, the severity of infection, or the tempo of disease progression. An increased incidence of bacterial and fungal infections, and graft rejection, have been reported in association with cytomegalovirus (CMV), and human herpesviruses type 6 and type 7 infections have been implicated as risk factors for CMV infection and graft rejection. Beta-herpesviruses may also interact with HIV-1 and hepatitis C. To prove a causal relationship between beta-herpesviruses and specific clinical outcomes, randomized trials, with selective suppression of the virus, are required. Such trials have been performed for CMV and showed a reduction in bacterial and fungal infections as well as rejection in selected solid organ transplant recipients. More trials are needed to evaluate whether the effects seen in observational studies are truly related.  N. Ref:: 61

 

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[86]

TÍTULO / TITLE:  - Clinical experience with drug-eluting stents.

REVISTA / JOURNAL:  - Rev Cardiovasc Med 2002;3 Suppl 5:S31-7.

AUTORES / AUTHORS:  - Drachman DE

INSTITUCIÓN / INSTITUTION:  - Department of Medicine, (Knight Cardiac Catheterization Laboratory, Cardiovascular Division, Massachusetts General Hospital) Harvard Medical School, Boston, Massachusetts, USA.

RESUMEN / SUMMARY:  - Despite dramatic improvements in catheter and stent technology, in-stent restenosis continues to hamper initial procedural success in 10% to 50% of patients undergoing coronary intervention. Recent breakthroughs in polymer science and local drug delivery have shown tremendous promise in the long-sought-after goal of delivering antirestenotic therapy directly from a stent. Clinical trials examining several novel antirestenotic agents, particularly sirolimus and paclitaxel, have shown astonishing reduction in restenosis following stenting. Through examination of the clinical experience to date, we may gain insight into the current and future utility of drug-eluting stents in our clinical practice.  N. Ref:: 21

 

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[87]

TÍTULO / TITLE:  - Initial experience with paclitaxel-coated stents.

REVISTA / JOURNAL:  - J Interv Cardiol 2002 Dec;15(6):471-5.

AUTORES / AUTHORS:  - Grube E; Bullesfeld L

INSTITUCIÓN / INSTITUTION:  - Heart-Center Siegburg, Ringstrasse 49, 53721 Siegburg, Germany. GrubeE@aol.com

RESUMEN / SUMMARY:  - Local delivery of immunosuppressive or antiproliferative agents using a drug-eluting stent is a new technology that is supposed to inhibit in-stent restenosis, thus providing a biological and mechanical solution. This technique is a very promising. To date, several agents have been used, including paclitaxel, QP-2, rapamycin, actinomycin D, dexamethason, tacrolimus, and everolimus. Several studies, published recently or still ongoing, have evaluated these drugs as to their release kinetics, effective dosage, safety in clinical practice, and benefit. These studies include: SCORE (paclitaxel derivative), TAXUS I-VI, ELUTES, ASPECT, DELIVER (paclitaxel), RAVEL, SIRIUS (sirolimus), ACTION (actinomycin), EVIDENT, PRESENT (tacrolimus), EMPEROR (dexamethason), and FUTURE (everolimus). Paclitaxel was one of the first stent-based antiproliferative agents under clinical investigation that provided profound inhibition of neointimal thickening depending on delivery duration and drug dosage. The randomized, multicenter SCORE trail (Quanam stent, paclitaxel-coated) enrolled 266 patients at 17 sites. At 6-month’s follow-up, a drop of 83% in stent restenosis using the drug-eluting stent could be achieved (6.4% drug-eluting stent vs 36.9% control group), which was attributable to a remarkable decrease in intimal proliferation. Unfortunately, due to frequent stent thrombosis and side-branch occlusions, the reported 30-day MACE rate was 10.2%. The randomized TAXUS-I safety trial (BSC, NIRx, paclitaxel-coated) also demonstrated beneficial reduction of restenotic lesions at 6-month’s follow-up (0% vs 10%) but was associated with the absence of thrombotic events presumably due to less drug dosage. The ongoing TAXUS II-VI trials are addressing additional insight regarding the efficacy of the TAXUS paclitaxel-eluting stent. ASPECT and ELUTES evaluated paclitaxel-coated stents (i.e., Cook and Supra G), including subgroups with different drug dosages. With respect to stent restenosis and neointimal proliferation, both studies demonstrated a clear dose response. The RAVEL and the SIRIUS trials evaluated sirolimus-coated stents (i.e., Cordis, Johnson & Johnson, and Bx VELOCITY stents). Results confirmed the beneficial findings regarding reduction of renarrowing using a drug-eluting stent without any major adverse effects. Although parameters such as drug toxicity, optimal drug dosage, or delayed endothelial healing still need to be evaluated, today’s clinical experience indicates that drug-coated stents are extremely beneficial in the interventional treatment of coronary lesions.  N. Ref:: 20

 

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[88]

TÍTULO / TITLE:  - Sirolimus eluting stent in the treatment of atherosclerosis coronary artery disease.

REVISTA / JOURNAL:  - Minerva Cardioangiol 2002 Oct;50(5):405-18.

AUTORES / AUTHORS:  - Degertekin M; Regar E; Tanabe K; Lee CH; Serruys PW

INSTITUCIÓN / INSTITUTION:  - Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.

RESUMEN / SUMMARY:  - Stent implantation represents the most commonly performed percutaneous coronary intervention nowadays. However, instent restenosis due to exaggerated neointimal hyperplasia remains a problem to overcome. Neointimal hyperplasia is a vascular response to stent injury; it mainly consists of smooth muscle cells proliferation. The underlying molecular mechanisms of restenosis were explained in this review article. Recently, drug-eluting stent has been proposed as a potential method to prevent instent restenosis. Animal studies have confirmed safety and efficacy of sirolimus-eluting stent implantation in vivo. The FIM trial, which was the first clinical study on sirolimus-eluting stent in de novo lesions, has shown an astonishing 0% restenosis rate. The RAVEL trial was the first prospective, double-blind, multi-center trial that randomized 238 patients at 19 institutions with de novo lesions into sirolimus-eluting versus bare Bx velocity stent. Six-month binary restenosis rate in the sirolimus-group was again 0% compared to 26.6% in the control group. Angiographic late loss and major cardiac event were also significantly lower in the sirolimus-group. The SIRIUS trial is an ongoing study conducted in 53 US centers that randomized 1100 patients with de novo lesion into sirolimus-eluting and bare stents. Preliminary results also showed a significant reduction in binary restenosis, late loss and repeat revascularization rates. Apart from de novo lesions, early experience of sirolimus-eluting stent implantation for instent restenosis in non-randomized study was also promising, achieving a single-digit repeat restenosis rate. As compare with standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis and associated clinical events.  N. Ref:: 46

 

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[89]

TÍTULO / TITLE:  - Through the drug-eluting stent labyrinth.

REVISTA / JOURNAL:  - Ital Heart J 2003 Apr;4(4):236-45.

AUTORES / AUTHORS:  - Guagliumi G; Musumeci G; Vassileva A; Tespili M; Valsecchi O

INSTITUCIÓN / INSTITUTION:  - Cardiovascular Department, Ospedali Riuniti, Bergamo. guagliumig@interfree.it

RESUMEN / SUMMARY:  - For interventional cardiologists restenosis has represented the main limit for the successful long-term treatment of coronary artery disease. The past 2 years witnessed the extraordinary results of drug-eluting stents (DES), putting this technique at the center stage. The safety and efficacy of sirolimus and paclitaxel-eluting stents have been proved in large prospective, multicenter, randomized trials (RAVEL, SIRIUS, TAXUS II). It is possible that the introduction of DES will lead to substantial changes in the therapeutic and/or the economic strategies of the treatment of ischemic coronary artery disease (increase in the complexity of patients treated, reduction in surgical indications, growing costs). Realizing the potential value of this technology will require the successful management of more complex coronary situations (for lesions and patients characteristics). Many extreme situations are still unexplored, although for some of them studies are currently in progress or already being planned.  N. Ref:: 40

 

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[90]

TÍTULO / TITLE:  - Drug-eluting stents: clinical experiences and perspectives.

REVISTA / JOURNAL:  - Minerva Cardioangiol 2002 Oct;50(5):469-73.

AUTORES / AUTHORS:  - Grube E; Gerckens U; Buellesfeld L

INSTITUCIÓN / INSTITUTION:  - Heart Center Siegburg, Siegburg, Germany, Italy. GrubeE@aol.com

RESUMEN / SUMMARY:  - Drug-eluting stents (DES) have entered the arena and are about to changed the landscape of Interventional Cardiology. Today, the number of agents under preclinical and clinical investigation has increased considerably, including drugs such as Paclitaxel, Sirolimus, Tacrolimus, Everolimus, Dexamethasone, etc. Several studies have recently been published or are still ongoing evaluating different stent designs with respect to their safety and efficacy in treatment of coronary lesions. The SCORE trial (Paclitaxel) revealed a significant reduction in restenosis at follow-up (FU) in the drug-eluting stent group (6.4% vs 36.9% control group), attributable to decreased intimal proliferation. However, stentthromboses and myocardial infarctions, due to both stent design and high drug dosages, were observed causing a MACE rate of 10.2% in the DES group. Confirming the beneficial reduction of stent renarrowing using a local drug-eluting device, the rate of restenosis in the TAXUS-I trial (Paclitaxel) was 0% at follow-up in patients with DES vs 10% in patients with bare stents. Differences in MACE were not observed, which underlined the potential impact of an optimal stent design. First clinical experiences with a Sirolimus-coated stent (FIM trial) demonstrated again a profound inhibition of neointimal ingrowth at 4-month follow-up. The RAVEL trial, the first multicenter trial evaluating the Sirolimus stent and the largest DES study published so far, confirmed the FIM findings with a rate of restenosis in the DES group of 0% at 6 month FU. At 12 month FU, the beneficial impact on neointimal growth inhibition was persistent. The pivotal study SIRIUS is addressed to evaluate this stent design more extensively. However, given all the results being available today, local application of anti-proliferative agents delivered by coronary stents is one of the most promising techniques in treatment of coronary lesions. Nevertheless, we need more trials and an agreement of definitions in order to evaluate this treatment concept and eliminate unwanted side-effects.  N. Ref:: 8

 

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[91]

TÍTULO / TITLE:  - Modern strategies to prevent coronary restenosis.

REVISTA / JOURNAL:  - Ital Heart J 2002 Jun;3 Suppl 4:9S-15S.

AUTORES / AUTHORS:  - Chieffo A; Stankovic G; Colombo A

INSTITUCIÓN / INSTITUTION:  - Laboratory of Interventional Cardiology, EMO Centro Cuore Columbus, Fondazione Centro San Raffaele del Monte Tabor, Milan, Italy.  N. Ref:: 49

 

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[92]

TÍTULO / TITLE:  - Drug-eluting stent: the emerging technique for the prevention of restenosis.

REVISTA / JOURNAL:  - Minerva Cardioangiol 2002 Oct;50(5):443-53.

AUTORES / AUTHORS:  - Sheiban I; Carrieri L; Catuzzo B; Destefanis P; Oliaro E; Moretti C; Trevi GP

INSTITUCIÓN / INSTITUTION:  - Interventional Cardiology, Division of Cardiology, San Giovanni Battista Hospital, University of Turin, Turin, Italy. isheiban@yahoo.com

RESUMEN / SUMMARY:  - Percutaneous coronary interventions (PCI) have surpassed coronary artery bypass grafting as the most common means for treating coronary artery disease, because of materials improvement, the use of stent and pharmacotherapy. However, despite the variety of mechanical techniques such as dilatation, debulking or conventional stent implantation, the incidence of restenosis on short and mid-term follow-up is still representing an important limitation to PCI. Restenosis is mainly due to elastic recoil, negative vessel remodelling and neointimal proliferation, as a response to vessel injury induced by angioplasty devices. The use of conventional stents has provided an efficient method to avoid elastic recoil and negative vessel remodelling, thus partially reducing restenosis as compared to conventional balloon dilatation. However, neointimal proliferation (biological vessel response to injury caused by stent implantation) is not affected by stenting technique. Thus, the extensive use of coronary stent, even in complex lesions, have produced again a “new” disease: the in-stent restenosis especially in some patients’ subset (diabetics) or in some lesion subset (bifurcations, long lesions, small vessels, total occlusions, diffuse disease). Therefore, the main target of today’s interventional cardiologists is to resolve this problem. The combination between mechanical control of elastic recoil and negative remodelling (stent) and the control of neointimal proliferation - biological response to vessel injury - (antiproliferative drugs) is the emerging approach against restenosis. This emerging approach consists in using the stent as drug carrier to the target site. Local delivery of antiproliferative or immunosuppressive agents using a drug-coated stent is supposed to inhibit in stent restenosis. The first antiproliferative agents being used successfully in clinical trials are sirolimus and paclitaxel and, so far, the data available of these trials demonstrated a marked reduction of restenosis using sirolimus- and paclitaxel-coated stents as compared to conventional stents. However, many questions are still to be answered and several other clinical trials with drug-eluting stents are ongoing, evaluating safety and efficacy of sirolimus and paclitaxel in a larger number of patients and in different subset of coronary lesions type and morphology. Based on the very impressive results available at the present time, we can expect, in the very near future, remarkable changes in our clinical practice and the beginning of a new “era” of interventional cardiology.  N. Ref:: 69

 

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[93]

TÍTULO / TITLE:  - Drug-eluting stents.

REVISTA / JOURNAL:  - Minerva Cardioangiol 2002 Oct;50(5):419-29.

AUTORES / AUTHORS:  - Chieffo A; Colombo A

INSTITUCIÓN / INSTITUTION:  - Interventional Cardiology EMO, Centro Cuore Columbus and San Raffaele Hospital, Milan, Italy.

RESUMEN / SUMMARY:  - Drug-eluting stents represent the third revolution in the field of Interventional Cardiology following balloon angioplasty (PTCA) and the implantation of metal stents. The main limitation of percutaneous coronary intervention (PCI) is restenosis. The introduction of drug eluting stents able to release antiproliferative compounds led to the evaluation of several antiproliferative drugs in order to reduce restenosis. Rapamycin (Sirolimus) has been demonstrated to inhibit smooth muscle cell (SMC) proliferation and migration in vitro and to reduce in vivo neointima formation with blockage of the cell cycle progression at the G1-S transition. In a pilot study, recently confirmed by a randomized trial, rapamycin drug-eluting stents have been reported to eliminate restenosis after stent implantation. Promising data also come from the use of paclitaxel drug-eluting stents. Paclitaxel (Taxol) is a microtubule-stabilizing agent with potent antiproliferative activity. Even if drug-eluting stents represent one of the most promising fields in Interventional Cardiology today before being sure of their real potential it is necessary to wait for results from several ongoing clinical studies, their usage in real-world lesions and extended follow-up to 5 years.  N. Ref:: 41

 

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[94]

TÍTULO / TITLE:  - Restenosis in percutaneous coronary intervention—is drug-eluting stent the answer?

REVISTA / JOURNAL:  - Singapore Med J 2003 Sep;44(9):482-7.

AUTORES / AUTHORS:  - Lim VY; Lim YL

INSTITUCIÓN / INSTITUTION:  - Division of Cardiology, Changi General Hospital, 2 Simei Street 3, Singapore 529889. victor_lim@cgh.com.sg

RESUMEN / SUMMARY:  - The long-term success of percutaneous coronary intervention in the treatment of coronary artery disease is hampered by the occurrence of restenosis, which often necessitates repeat hospitalisations or coronary interventions. The advent of drug-eluting stents, particularly those coated with sirolimus and paclitaxel, may be the breakthrough in the battle against restenosis that interventional cardiologists have been waiting for, and we review the currently available evidence for this. Despite the growing enthusiasm, we should not forget that this new technology is still in its relative infancy, and there remain many unanswered questions, particularly about the long-term effect of using these stents.  N. Ref:: 33

 

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[95]

TÍTULO / TITLE:  - Drug-eluting stents in the treatment of atherosclerotic coronary heart disease.

REVISTA / JOURNAL:  - Indian Heart J 2002 Mar-Apr;54(2):212-6.

AUTORES / AUTHORS:  - Lemos PA; Regar E; Serruys PW

INSTITUCIÓN / INSTITUTION:  - Department of Cardiology, Thoraxcentre, Erasmus Medical Centre, Rotterdam.  N. Ref:: 47

 

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[96]

TÍTULO / TITLE:  - Drug-eluting stents to prevent reblockage of coronary arteries.

REVISTA / JOURNAL:  - J Cardiovasc Nurs 2003 Jan-Mar;18(1):11-6.

AUTORES / AUTHORS:  - Schwertz DW; Vaitkus P

INSTITUCIÓN / INSTITUTION:  - Department of Medical Surgical Nursing, University of Illinois, Chicago, Illinois, USA.

RESUMEN / SUMMARY:  - Restenosis limits the success of percutaneous transluminal coronary interventions. Coronary artery stenting decreases restenosis, improves outcomes, and is currently the most commonly used percutaneous coronary intervention in the United States. However, in-stent restenosis continues to occur at an unacceptable rate. In-stent restenosis is a neointimal hyperplastic response resulting primarily from vascular smooth muscle cell proliferation. Treatment with anti-proliferative agents presents a logical approach to eradicating restenosis, however, these drugs are highly toxic. Coating stents with anti-proliferative agents allows local delivery of high doses and avoids systemic side effects. In 2001, the results of two clinical trials, RAVEL and ELUTES, using sirolimus- and paclitaxil-coated stents demonstrated nearly complete elimination of in-stent restenosis. These dramatic results represent a tremendous advance in the treatment of coronary heart disease.  N. Ref:: 23

 

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