Incidence of Posttransplant Diabetes Mellitus in Kidney Transplant Recipients Immunosuppressed With Sirolimus in Combination With Cyclosporine J. Romagnoli, F. Citterio, G. Nanni, E. Favi, V. Tondolo, G. Spagnoletti, M. Paola Salerno, and M. Castagneto ABSTRACT Sirolimus (SRL) in combination with Cyclosporine A (CsA) and steroids has been shown to lower the incidence of acute renal allograft rejection episodes, allowing CsA sparing. We retrospectively compared the incidence of posttransplant diabetes mellitus (PTDM) among kidney transplant recipients (KTx) immunosuppressed with SRL+CsA versus CsA alone. Patients were divided into two groups: SRL+CsA (n = 38) versus CsA (n = 48). Mean follow-up was 53.9  17.1 months. Seventeen/86 subjects (19.8%) developed diabetes after transplantation (7 IFG, 8.1%; 10 PTDM, 11.6%). The incidence was significantly higher in SRL+CsA (12/38 patients, 31.6%) compared with CsA (5/43 patients, 10.4%) (P = .0144, odds ratio 3.97). More patients required treatment in the SRL+CsA compared to CsA alone cohort (13.2% vs 2.1%, P = .051): 4 pts (10.5%) became insulin- dependent among SRL+CsA, vs none in the CsA group. Use of OHD was similar in both groups (2.6% SRL+CsA vs 2.1% CsA). There were no significant differences between the two groups in terms of age, sex distribution, BMI, or serum creatinine at 1 to 3 and 5 years from transplantation. All PTDM patients are alive at follow-up, while two grafts were lost due to chronic renal allograft dysfunction. Within the limits of a small retrospective study, we observed that SRL in combination with CsA increased the diabetogenic potential of CsA. A possible explanation of our findings is that higher CsA doses were used in the early experience with SRL+CsA; therefore the higher incidence of PTDM that we observed in the SRL+CsA combination may be a sign of toxicity. Careful monitoring of blood levels is mandatory in the SRL+CsA combination to avoid pleiotropic toxicity. D iabetes is a strong risk factor for cardiovascular dis- ease in the general population and among renal trans- plant recipients. 1 Prevention and early diagnosis of this con- dition are therefore of paramount importance due to the impact of this complication on both graft and patient sur- vival. The new American Diabetes Association (ADA) crite- ria for diagnosing diabetes 2,3 have allowed for the detection of previously unrecognized cases of posttransplant diabetes mellitus (PTDM). Sirolimus (SRL) in combination with Cyclosporine (CsA) and steroids has been shown to lower the incidence of acute renal allograft rejection episodes, allowing CsA sparing. 4 In order to understand whether this combination might increase the diabetogenic potential of CsA, we retrospectively compared the incidence of post- transplant diabetes mellitus (PTDM) among kidney trans- plant recipients (KTx) immunosuppressed with SRL+CsA versus CsA alone. METHODS The incidence of PTDM was analyzed in a population of KTx performed at a single institution between January 1997 and De- cember 2004 excluding subjects with pre-transplant diabetes, post- operative follow-up less than 12 months or conversion from initial immunosuppression before 1 year since transplantation. Eighty-six From the Department of Surgery, Organ Transplantation, Catholic University, Policlinico Gemelli, Rome, Italy. Address correspondence to Jacopo Romagnoli, Clinica Chiru- rgica, U.O. Chirurgia Generale e Trapianti d’Organo, Policlinico “A. Gemelli,” Università Cattolica del Sacro Cuore, Largo Gemelli 8, 00168, Roma, Italy. E-mail: jromagnoli@rm.unicatt.it 0041-1345/06/$–see front matter © 2006 by Elsevier Inc. All rights reserved. doi:10.1016/j.transproceed.2006.03.072 360 Park Avenue South, New York, NY 10010-1710 1034 Transplantation Proceedings, 38, 1034 –1036 (2006)