Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus

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 immunos...

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Authors: 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, Porrini E
Format: article
Status:Published version
Publication Date:2018
Country:España
Institution:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repository:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p2632
Online Access:https://fisabio.portalinvestigacion.com/publicaciones/2632
Access Level:Open access
Keyword:cyclosporin A
posttransplant diabetes
posttransplant hyperglycemia
renal transplantation
steroid withdrawal
tacrolimus
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spelling Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes MellitusTorres AHernández DMoreso FSerón DBurgos MDPallardó LMKanter JDíaz Corte CRodríguez MDiaz JMSilva IValdes FFernández-Rivera COsuna AGracia Guindo MCGómez Alamillo CRuiz JCMarrero Miranda DPérez-Tamajón LRodríguez AGonzález-Rinne AAlvarez APerez-Carreño Ede la Vega Prieto MJHenriquez FGallego RSalido EPorrini Ecyclosporin Aposttransplant diabetesposttransplant hyperglycemiarenal transplantationsteroid withdrawaltacrolimusIntroduction: 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.ELSEVIER SCIENCE INC2018info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/2632Kidney International ReportsISSN: 24680249reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p26322026-06-11T12:45:17Z
dc.title.none.fl_str_mv Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
title Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
spellingShingle Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
Torres A
cyclosporin A
posttransplant diabetes
posttransplant hyperglycemia
renal transplantation
steroid withdrawal
tacrolimus
title_short Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
title_full Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
title_fullStr Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
title_full_unstemmed Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
title_sort Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus
dc.creator.none.fl_str_mv 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
Porrini E
author Torres A
author_facet 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
Porrini E
author_role author
author2 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
Porrini E
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv cyclosporin A
posttransplant diabetes
posttransplant hyperglycemia
renal transplantation
steroid withdrawal
tacrolimus
topic cyclosporin A
posttransplant diabetes
posttransplant hyperglycemia
renal transplantation
steroid withdrawal
tacrolimus
description 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.
publishDate 2018
dc.date.none.fl_str_mv 2018
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fisabio.portalinvestigacion.com/publicaciones/2632
url https://fisabio.portalinvestigacion.com/publicaciones/2632
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv ELSEVIER SCIENCE INC
publisher.none.fl_str_mv ELSEVIER SCIENCE INC
dc.source.none.fl_str_mv Kidney International Reports
ISSN: 24680249
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812429

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