%0 Journal Article
%A Torres, Armando
%A Hernández, Domingo
%A Moreso, Francesc
%A Serón, Daniel
%A Burgos, María Dolores
%A Pallardó, Luis M
%A Kanter, Julia
%A Díaz Corte, Carmen
%A Rodríguez, Minerva
%A Diaz, Juan Manuel
%A Silva, Irene
%A Valdes, Francisco
%A Fernández-Rivera, Constantino
%A Osuna, Antonio
%A Gracia Guindo, María C
%A Gómez Alamillo, Carlos
%A Ruiz, Juan C
%A Marrero Miranda, Domingo
%A Pérez-Tamajón, Lourdes
%A Rodríguez, Aurelio
%A González-Rinne, Ana
%A Alvarez, Alejandra
%A Perez-Carreño, Estefanía
%A de la Vega Prieto, María José
%A Henriquez, Fernando
%A Gallego, Roberto
%A Salido, Eduardo
%A Porrini, Esteban
%T Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus.
%D 2018
%U https://hdl.handle.net/10668/25187
%X Despite the high incidence of posttransplant diabetes mellitus (PTDM) among high-risk recipients, no studies have investigated its prevention by immunosuppression optimization. We conducted an open-label, multicenter, randomized trial testing whether a tacrolimus-based immunosuppression and rapid steroid withdrawal (SW) within 1 week (Tac-SW) or cyclosporine A (CsA) with steroid minimization (SM) (CsA-SM), decreased the incidence of PTDM compared with tacrolimus with SM (Tac-SM). All arms received basiliximab and mycophenolate mofetil. High risk was defined by age >60 or >45 years plus metabolic criteria based on body mass index, triglycerides, and high-density lipoprotein-cholesterol levels. The primary endpoint was the incidence of PTDM after 12 months. The study comprised 128 de novo renal transplant recipients without pretransplant diabetes (Tac-SW: 44, Tac-SM: 42, CsA-SM: 42). The 1-year incidence of PTDM in each arm was 37.8% for Tac-SW, 25.7% for Tac-SM, and 9.7% for CsA-SM (relative risk [RR] Tac-SW vs. CsA-SM 3.9 [1.2-12.4; P = 0.01]; RR Tac-SM vs. CsA-SM 2.7 [0.8-8.9; P = 0.1]). Antidiabetic therapy was required less commonly in the CsA-SM arm (P = 0.06); however, acute rejection rate was higher in CsA-SM arm (Tac-SW 11.4%, Tac-SM 4.8%, and CsA-SM 21.4% of patients; cumulative incidence P = 0.04). Graft and patient survival, and graft function were similar among arms. In high-risk patients, tacrolimus-based immunosuppression with SM provides the best balance between PTDM and acute rejection incidence.
%K cyclosporin A
%K posttransplant diabetes
%K posttransplant hyperglycemia
%K renal transplantation
%K steroid withdrawal
%K tacrolimus
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