Cantarovich D, Kervella D, Karam G, et al. - In view of the possibility of nephrotoxic and diabetogenic effects of tacrolimus, the cornerstone immunosuppression after simultaneous pancreas and kidney transplantation, an open-label, randomized, monocentric, 5-year follow-up study was performed to compare tacrolimus- vs sirolimus-based immunosuppressive regimen. Researchers performed randomization using the block method enabling a blind allocation at the time of surgery. Anti-thymocyte globulin and maintenance therapy with tacrolimus, mycophenolate mofetil, and steroids were provided to all patients. Tacrolimus was either continued or was replaced by sirolimus at month 3. In the final analysis, each group comprised 50 patients. Definitive withdrawal of the study drug was required in 34 patients (68 %) in the sirolimus group vs 3 (6 %) in the tacrolimus group. Observations revealed the non-inferiority of sirolimus vs tacrolimus for kidney and pancreas graft survival, however, there was a high rate of sirolimus discontinuation that does not favor its use as cornerstone therapy after simultaneous pancreas and kidney transplantation.