Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
Torres, Armando (Hospital Universitario de Canarias (La Laguna))
Hernández, Domingo (Instituto de Investigación Biomédica de Málaga)
Moreso, Francesc (Universitat Autònoma de Barcelona. Departament de Medicina)
Seron, Daniel (Universitat Autònoma de Barcelona. Departament de Medicina)
Burgos, María Dolores (Instituto de Investigación Biomédica de Málaga)
Pallardó, Luis M. (Hospital Universitari Doctor Peset (València))
Kanter, Julia (Hospital Universitari Doctor Peset (València))
Díaz Corte, Carmen (Hospital Universitario Central de Asturias)
Rodríguez, Minerva (Hospital Universitario Central de Asturias)
Díaz Gómez, Juan Manuel (Institut d'Investigació Biomèdica Sant Pau)
Silva, Irene (Institut d'Investigació Biomèdica Sant Pau)
Valdes, Francisco (Complejo Hospitalario Universitario de A Coruña)
Fernández-Rivera, Constantino (Complejo Hospitalario Universitario de A Coruña)
Osuna, Antonio (Hospital Universitario Virgen de las Nieves (Granada))
Gracia Guindo, María C. (Hospital Universitario Virgen de las Nieves (Granada))
Gómez Alamillo, Carlos (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Ruiz, Juan C. (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Marrero Miranda, Domingo (Hospital Universitario de Canarias (La Laguna))
Pérez-Tamajón, Lourdes (Hospital Universitario de Canarias (La Laguna))
Rodríguez, Aurelio (Hospital Universitario de Canarias (La Laguna))
González-Rinne, Ana (Hospital Universitario de Canarias (La Laguna))
Alvarez, Alejandra (Hospital Universitario de Canarias (La Laguna))
Perez-Carreño, Estefanía (Hospital Universitario de Canarias (La Laguna))
de la Vega Prieto, María José (Hospital Universitario de Canarias (La Laguna))
Henriquez, Fernando (Hospital Universitario de Gran Canaria Dr. Negrín)
Gallego Samper, Roberto (Hospital Universitario de Gran Canaria Dr. Negrín)
Salido, Eduardo (Hospital Universitario de Canarias (La Laguna))
Porrini, Esteban (Hospital Universitario de Canarias (La Laguna))
Universitat Autònoma de Barcelona

Date:	2018
Abstract:	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.
Grants:	European Commission 00055 Instituto de Salud Carlos III RD16/0009/0031 Instituto de Salud Carlos III RD16/0009/0006 Instituto de Salud Carlos III RD16/0009/0030
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Cyclosporin A ; Posttransplant diabetes ; Posttransplant hyperglycemia ; Renal transplantation ; Steroid withdrawal ; Tacrolimus
Published in:	Kidney International Reports, Vol. 3 (july 2018) , p. 1304-1315, ISSN 2468-0249

DOI: 10.1016/j.ekir.2018.07.009
PMID: 30450457

12 p, 571.6 KB

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