Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
| Autor: | 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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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Steroid withdrawal Basiliximab medicine.medical_treatment 030232 urology & nephrology 030230 surgery Gastroenterology Tacrolimus 03 medical and health sciences 0302 clinical medicine Clinical Research Diabetes mellitus Cyclosporin a Internal medicine Clinical endpoint Medicine posttransplant hyperglycemia Cumulative incidence Posttransplant hyperglycemia tacrolimus steroid withdrawal business.industry Incidence (epidemiology) Immunosuppression Renal transplantation posttransplant diabetes renal transplantation medicine.disease cyclosporin A Cyclosporin A Nephrology business Posttransplant diabetes medicine.drug |
| Zdroj: | Kidney International Reports |
| Popis: | Introduction Despite the high incidence of posttransplant diabetes mellitus (PTDM) among high-risk recipients, no studies have investigated its prevention by immunosuppression optimization. Methods 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. Results 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. Conclusion In high-risk patients, tacrolimus-based immunosuppression with SM provides the best balance between PTDM and acute rejection incidence. |
| Databáze: | OpenAIRE |
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