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Cyclosporine Versus Tacrolimus in Immunosuppressive Maintenance Regimens in Renal Transplants in Brazil: Survival Analysis from 2000 to 2004

PhD Student, Department of Preventive and Social Medicine, Faculty of Medicine, Federal University of Minas Gerais, Belo Horizonte, MG, Brazil; Superintendent of Pharmaceutical Assistance, Minas Gerais State Health Secretary, Belo Horizonte

Cibele Comini Cesar, PhD

Statistician, Professor, Department of Statistics, Institute of Exact Sciences, Federal University of Minas Gerais

Mariângela Leal Cherchiglia, MD PhD

Professor, Department of Preventive and Social Medicine, Faculty of Medicine, Federal University of Minas Gerais

Eli Iola Gurgel Andrade, PhD

Economist, Professor, Department of Preventive and Social Medicine, Faculty of Medicine, Federal University of Minas Gerais

Odilon Vanni de Queiroz, MD MSc

Researcher, Department of Preventive and Social Medicine, Faculty of Medicine, Federal University of Minas Gerais

Grazielle D Silva, MSc

Pharmacist, Researcher, Department of Preventive and Social Medicine, Faculty of Medicine, Federal University of Minas Gerais

Francisco de Assis Acurcio, MD ScD

Professor, Department of Social Pharmacy, Faculty of Pharmacy, Federal University of Minas Gerais

Reprints: Dr. de Assis Acurcio, Department of Social Pharmacy, Faculty of Pharmacy, Federal University of Minas Gerais, Av. Antônio Carlos, 6627, FAFAR. Sala 1048B2, Belo Horizonte, MG, Brazil, 31.270-901, fax 55 31 34096852, acurcio{at}ufmg.br

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 immunosuppression that is essential for successful renal transplant. Alternatively, cyclosporine 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 glomerulonephritis/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 compliance with SUS clinical protocols could result in more effective care for renal transplant recipients.

Key Words: cyclosporine, graft rejection, kidney transplant, survival, tacrolimus

Published Online, December 15, 2009. www.theannals.com, DOI 10.1345/aph.1M244