INTRODUCTION: Sirolimus (SRL) is an immunosuppressive drug with confirmed efficacy and safety profile in the prophylaxis of acute rejection after renal transplantation. OBJECTIVES: To assess the efficacy, safety, and tolerability of SRL and prednisone in combination with cyclosporine (CSA) or tacrolimus (TAC) after renal transplantation. METHODS: Retrospective study of 332 renal transplant recipients from 1999 to 2006. Primary outcome included treatment failure, defined as the cumulative incidence of biopsy-proven acute rejection, graft loss, death, or SRL discontinuation. RESULTS: Living donors were the primary source of kidneys (92%). Regarding the recipients, mean age was 37 years, 65% were males, 46% were white, and the prevalence of diabetes was 6%. Sirolimus was combined with CSA and TAC in 70.8% and 29.2% of patients, respectively. Treatment failure rates at the first and fifth year of transplantation were 22.2% and 47.8%, respectively, without difference between the groups receiving CSA and TAC. At five years, the survival rates were as follows: patient's, 92.8%; graft's, 86.1%; deathcensored graft's, 92.7%; and free from biopsy-proven acute rejection, 82.2%. Treatment with SRL was discontinued in 27.1% of the patients, due to adverse effects (22.9%) and inefficacy (3.3%). The main reasons for SRL discontinuation were as follows: dyslipidemia (6%); graft dysfunction (5.2%); proteinuria (4.5%); infection (1.5%); delayed wound healing (1.2%); and anemia (0.9%). CONCLUSION: In this cohort of patients, SRL efficacy and safety were similar when combined with either CSA or TAC. Oral tolerability was adequate, considering the relatively low SRL discontinuation rate.
sirolimus; drug tolerability; efficacy; safety; renal transplantation
