Títol:
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Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
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Autor/a:
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Torres, Armando; Hernández, Domingo; Moreso, Francesc; Serón, Daniel; Burgos, María Dolores; Pallardó, Luis M.; Kanter, Julia; Díaz Corte, Carmen; Rodríguez, Minerva; Díaz Gómez, Juan Manuel; Silva, Irene; Valdes, Francisco; Fernández-Rivera, Constantino; Osuna, Antonio; Gracia Guindo, María C.; Gómez Alamillo, Carlos; Ruiz, Juan C.; Marrero Miranda, Domingo; Pérez-Tamajón, Lourdes; Rodríguez, Aurelio; González-Rinne, Ana; Alvarez, Alejandra; Perez-Carreño, Estefanía; de la Vega Prieto, María José; Henriquez, Fernando; Gallego Samper, Roberto; Salido, Eduardo; Porrini, Esteban; Universitat Autònoma de Barcelona
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Abstract:
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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. |
Matèries:
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-Cyclosporin A -Posttransplant diabetes -Posttransplant hyperglycemia -Renal transplantation -Steroid withdrawal -Tacrolimus |
Drets:
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open access
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Article |
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Uri:
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https://ddd.uab.cat/record/211387
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