Torres, ArmandoHernández, DomingoMoreso, FrancescSerón, DanielBurgos, María DoloresPallardó, Luis MKanter, JuliaDíaz Corte, CarmenRodríguez, MinervaDiaz, Juan ManuelSilva, IreneValdes, FranciscoFernández-Rivera, ConstantinoOsuna, AntonioGracia Guindo, María CGómez Alamillo, CarlosRuiz, Juan CMarrero Miranda, DomingoPérez-Tamajón, LourdesRodríguez, AurelioGonzález-Rinne, AnaAlvarez, AlejandraPerez-Carreño, Estefaníade la Vega Prieto, María JoséHenriquez, FernandoGallego, RobertoSalido, EduardoPorrini, Esteban2025-01-072025-01-072018-07-11https://hdl.handle.net/10668/25187Despite 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.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/cyclosporin Aposttransplant diabetesposttransplant hyperglycemiarenal transplantationsteroid withdrawaltacrolimusresearch article30450457open access10.1016/j.ekir.2018.07.0092468-0249PMC6224662http://www.kireports.org/article/S2468024918301554/pdfhttps://pmc.ncbi.nlm.nih.gov/articles/PMC6224662/pdf