Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
Por:
Torres A, Hernández D, Moreso F, Serón D, Burgos MD, Pallardó LM, Kanter J, Díaz Corte C, Rodríguez M, Diaz JM, Silva I, Valdes F, Fernández-Rivera C, Osuna A, Gracia Guindo MC, Gómez Alamillo C, Ruiz JC, Marrero Miranda D, Pérez-Tamajón L, Rodríguez A, González-Rinne A, Alvarez A, Perez-Carreño E, de la Vega Prieto MJ, Henriquez F, Gallego R, Salido E and Porrini E
Publicada:
1 nov 2018
Categoría:
Nephrology
Resumen:
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 (TacSW: 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.
Filiaciones:
Torres A:
Hospital Universitario de Canarias, Instituto de Tecnologías Biomédicas (ITB)-Universidad de La Laguna, Tenerife, Spain
Hernández D:
Hospital Regional Universitario de Málaga, Universidad de Málaga, IBIMA, Málaga, Spain
Moreso F:
Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain
Serón D:
Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain
Burgos MD:
Hospital Regional Universitario de Málaga, Universidad de Málaga, IBIMA, Málaga, Spain
:
Hospital Universitario Dr Peset, Valencia, Spain
:
Hospital Universitario Dr Peset, Valencia, Spain
Díaz Corte C:
Hospital Universitario Central de Asturias, Oviedo, Spain
Rodríguez M:
Hospital Universitario Central de Asturias, Oviedo, Spain
Diaz JM:
Fundació Puigvert, Barcelona, Spain
Silva I:
Fundació Puigvert, Barcelona, Spain
Valdes F:
Complexo Hospitalario Universitario Juan Canalejo, A Coruña, Spain
Fernández-Rivera C:
Complexo Hospitalario Universitario Juan Canalejo, A Coruña, Spain
Osuna A:
Hospital Universitario Virgen de las Nieves, Granada, Spain
Gracia Guindo MC:
Hospital Universitario Virgen de las Nieves, Granada, Spain
Gómez Alamillo C:
Hospital Universitario Marqués de Valdecilla, Santander, Spain
Ruiz JC:
Hospital Universitario Marqués de Valdecilla, Santander, Spain
Marrero Miranda D:
Hospital Universitario de Canarias, Instituto de Tecnologías Biomédicas (ITB)-Universidad de La Laguna, Tenerife, Spain
Pérez-Tamajón L:
Hospital Universitario de Canarias, Instituto de Tecnologías Biomédicas (ITB)-Universidad de La Laguna, Tenerife, Spain
Rodríguez A:
Hospital Universitario de Canarias, Instituto de Tecnologías Biomédicas (ITB)-Universidad de La Laguna, Tenerife, Spain
González-Rinne A:
Hospital Universitario de Canarias, Instituto de Tecnologías Biomédicas (ITB)-Universidad de La Laguna, Tenerife, Spain
Alvarez A:
Hospital Universitario de Canarias, Instituto de Tecnologías Biomédicas (ITB)-Universidad de La Laguna, Tenerife, Spain
Perez-Carreño E:
Hospital Universitario de Canarias, Instituto de Tecnologías Biomédicas (ITB)-Universidad de La Laguna, Tenerife, Spain
de la Vega Prieto MJ:
Hospital Universitario de Canarias, Instituto de Tecnologías Biomédicas (ITB)-Universidad de La Laguna, Tenerife, Spain
Henriquez F:
Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de GC, Spain
Gallego R:
Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de GC, Spain
Salido E:
Hospital Universitario de Canarias, Instituto de Tecnologías Biomédicas (ITB)-Universidad de La Laguna, Tenerife, Spain
Porrini E:
Hospital Universitario de Canarias, Instituto de Tecnologías Biomédicas (ITB)-Universidad de La Laguna, Tenerife, Spain
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