192 ■ The Annals of Pharmacotherapy ■ 2010 January, Volume 44 theannals.com INTERNATIONAL REPORTS I n Brazil, the process of demographic transition is marked by rapid population aging, which contributes to the growth of chronic degenerative diseases. Of these, chronic renal failure (CRF) is conspicu- ous because of its high economic impact on the health system and its effect on quality of life. CRF is responsible for a growing number of patients undergoing renal replacement therapies (RRT) such as dialysis and renal transplantation. 1 The number of patients on dialysis in Brazil rose from 24,000 in 1994 to 58,000 in 2004, mirroring the increasing CRF incidence observed in Latin Ameri- ca and the US. 2-4 At present, more than 70,000 patients depend on renal replace- ment therapies and Brazil’s National Health System (Sistema Único de Saúde, SUS) spends around $1.0 billion (USD) per year on such therapies, including transplants. 2 Renal transplantation has been identi- fied in the literature as the most cost-ef- fective RRT because, in most cases, it enables patients to be reintegrated into their usual everyday activities, thus in- creasing the likelihood of improved out- look and quality of life compared to pa- tients undergoing dialysis. 5 One factor that has contributed substantially to renal transplantation being considered the best option for CRF is technological advances in immunosuppressive therapy. The main aim of such therapy is to prolong graft survival by preventing acute and chronic rejection of the transplanted organ. 6 Risk factors for developing chronic rejection include failure of the immunosuppressive regimen used in maintenance ther- apy and the presence and intensity of acute rejection episodes. Chronic transplant rejection, also termed chronic transplant nephropathy, is the main cause of graft loss after the first year, representing 20–70% of losses. 7 Cyclosporine Versus Tacrolimus in Immunosuppressive Maintenance Regimens in Renal Transplants in Brazil: Survival Analysis from 2000 to 2004 Augusto Afonso Guerra Jr, Cibele Comini Cesar, Mariângela Leal Cherchiglia, Eli Iola Gurgel Andrade, Odilon Vanni de Queiroz, Grazielle D Silva, and Francisco de Assis Acurcio Author information provided at end of text. BACKGROUND: In Brazil, the National Health System (SUS) is responsible for almost all renal transplants. SUS protocols recommend using cyclosporine, in association with azathioprine and corticosteroids, to maintain the immuno- suppression that is essential for successful renal transplant. Alternatively, cyclo- sporine can be replaced by tacrolimus. OBJECTIVE: To evaluate the effectiveness of therapeutic schema involving cyclosporine or tacrolimus after renal transplant during a 60-month follow-up period. METHODS: A historical cohort study, from 2000 to 2004, was conducted using 5686 patients who underwent renal transplant and received cyclosporine or tacrolimus. Uni - and multivariate analyses were performed using the Cox model to examine factors associated with progression to treatment failure. RESULTS: Most of the patients were male, aged 38 years or older, for whom the most frequent primary diagnosis of chronic renal failure (CRF) was glomerulone- phritis/nephritis. Higher risk of treatment failure was associated with: therapeutic regimen (tacrolimus, HR 1.38, 95% CI 1.14 to 1.67), patient age at transplantation (additional year, HR 1.01, 95% CI 1.00 to 1.02), donor type (deceased, HR 1.60, 95% CI 1.35 to 1.89), median time of dialysis prior to transplantation (>24 mo, HR 1.29, 95% CI 1.09 to 1.52), and primary CRF diagnosis (diabetes, HR 1.54, 95% CI 1.09 to 2.17). CONCLUSIONS: The risk of treatment failure of patients receiving tacrolimus was observed to be 1.38 times that of those receiving cyclosporine, after adjusting the model for possible confounding factors such as patient sex, patient age, graft origin, prior time of dialysis, and cause of CRF. Our results were obtained from an observational study, and further studies are necessary to evaluate whether compli- ance with SUS clinical protocols could result in more effective care for renal trans- plant recipients. KEY WORDS: cyclosporine, graft rejection, kidney transplant, survival, tacrolimus. Ann Pharmacother 2010;44:192-201. Published Online, 15 Dec 2009, theannals.com, DOI 10.1345/aph.1M244 by guest on October 11, 2013 aop.sagepub.com Downloaded from by guest on October 11, 2013 aop.sagepub.com Downloaded from by guest on October 11, 2013 aop.sagepub.com Downloaded from by guest on October 11, 2013 aop.sagepub.com Downloaded from by guest on October 11, 2013 aop.sagepub.com Downloaded from by guest on October 11, 2013 aop.sagepub.com Downloaded from by guest on October 11, 2013 aop.sagepub.com Downloaded from by guest on October 11, 2013 aop.sagepub.com Downloaded from by guest on October 11, 2013 aop.sagepub.com Downloaded from by guest on October 11, 2013 aop.sagepub.com Downloaded from