Steroid withdrawal in simultaneous pancreas-kidney transplantation: a 7-year report.

Simultaneous pancreas-kidney transplantation (SPK) is the treatment of choice for selected diabetic patients with end-stage renal disease. Maintenance steroid therapy is associated with significant morbidity and mortality among SPK transplant recipients. Steroid withdrawal regimens are becoming more common, albeit with reservations regarding its safety and efficacy. We performed a retrospective review of 77 SPK transplant recipients from May 2000 to December 2007. The subjects received induction therapy with thymoglobulin followed by maintenance immunosuppression with tacrolimus and mycophenolate mofetil. A late steroid withdrawal protocol was adopted. The rates of acute rejection, graft and patient survival, and side effects were analyzed. One-year patient, kidney, and pancreas survivals were 93%, 91%, and 86%, respectively. Eleven patients experienced acute rejection. Mean follow-up time was 1155.5 +/- 776.1 days. Prednisolone withdrawal was carried out between 6 and 12 months posttransplantation in 42 patients (77.8%) with at least 1 year follow-up; no case of acute rejection occurred. At present, 72 patients have a functioning kidney graft, and 65 patients also have a functioning pancreas graft. The mean serum creatinine is 1.12 +/- 0.49 mg/dL and the mean HbA1c concentration is 4.5% +/- 0.4%. The patients have a low prevalence of hypertension, hyperlipidemia, and obesity. Steroid withdrawal was successful and safe in the majority of in-study patients and safe without an increase of immune events. Our patient and graft outcomes are within other international SPK transplant units standards.