RT Journal Article
T1 Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus.
A1 Torres, Armando
A1 Hernández, Domingo
A1 Moreso, Francesc
A1 Serón, Daniel
A1 Burgos, María Dolores
A1 Pallardó, Luis M
A1 Kanter, Julia
A1 Díaz Corte, Carmen
A1 Rodríguez, Minerva
A1 Diaz, Juan Manuel
A1 Silva, Irene
A1 Valdes, Francisco
A1 Fernández-Rivera, Constantino
A1 Osuna, Antonio
A1 Gracia Guindo, María C
A1 Gómez Alamillo, Carlos
A1 Ruiz, Juan C
A1 Marrero Miranda, Domingo
A1 Pérez-Tamajón, Lourdes
A1 Rodríguez, Aurelio
A1 González-Rinne, Ana
A1 Alvarez, Alejandra
A1 Perez-Carreño, Estefanía
A1 de la Vega Prieto, María José
A1 Henriquez, Fernando
A1 Gallego, Roberto
A1 Salido, Eduardo
A1 Porrini, Esteban
K1 cyclosporin A
K1 posttransplant diabetes
K1 posttransplant hyperglycemia
K1 renal transplantation
K1 steroid withdrawal
K1 tacrolimus
AB 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.
YR 2018
FD 2018-07-11
LK https://hdl.handle.net/10668/25187
UL https://hdl.handle.net/10668/25187
LA en
DS RISalud
RD Apr 7, 2025