Miniatura

Fitxers

07_OR_8549_ing_copia.pdf (896.09 KB)

Tipus de document

Article

Versió

Versió acceptada

Data de publicació

2022-01-01

Tots els drets reservats

Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/187444

Everolimus plus minimized tacrolimus on kidney function in liver transplantation: REDUCE, a prospective, randomized controlled study

Títol de la revista

Autors

Director/Tutor

ISSN de la revista

Títol del volum

Recurs relacionat

https://doi.org/10.17235/reed.2022.8549/2021

Resum

Background and aim: reduction in calcineurin inhibitor levels is considered crucial to decrease the incidence of kidney dysfunction in liver transplant (LT) recipients. The aim of this study was to evaluate the safety and impact of everolimus plus reduced tacrolimus (EVR + rTAC) vs. mycophenolate mofetil plus tacrolimus (MMF + TAC) on kidney function in LT recipients from Spain. Methods: the REDUCE study was a 52-week, multicenter, randomized, controlled, open-label, phase 3b study in de novo LT recipients. Eligible patients were randomized (1:1) 28 days post-transplantation to receive EVR + rTAC (TAC levels <_ 5 ng/mL) or to continue with MMF + TAC (TAC levels = 6-10 ng/mL). Mean estimated glomerular filtration rate (eGFR), clinical benefit in renal function, and safety were evaluated. Results: in the EVR + rTAC group (n = 105), eGFR increased from randomization to week 52 (82.2 [28.5] mL/min/1.73 m2 to 86.1 [27.9] mL/min/1.73 m2) whereas it decreased in the MMF + TAC (n = 106) group (88.4 [34.3] mL/min/1.73 m2 to 83.2 [25.2] mL/min/1.73 m2), with significant (p < 0.05) differences in eGFR throughout the study. However, both groups had a similar clinical benefit regarding renal function (improvement in 18.6 % vs. 19.1 %, and stabilization in 81.4 % vs. 80.9 % of patients in the EVR + rTAC vs. MMF + TAC groups, respectively). There were no significant differences in the incidence of acute rejection (5.7 % vs. 3.8 %), deaths (5.7 % vs. 2.8 %), and serious adverse events (51.9 % vs. 44.0 %) between the 2 groups. Conclusion: EVR + rTAC allows a safe reduction in tacrolimus exposure in de novo liver transplant recipients, with a significant improvement in eGFR but without significant differences in renal clinical benefit 1 year after liver transplantation.

Matèries

Trasplantament hepàtic, Malalties del ronyó

Matèries (anglès)

Hepatic transplantation, Kidney diseases

Citació

Col·leccions

Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

GÓMEZ BRAVO, Miguel ángel, PRIETO CASTILLO, Martín, NAVASA, Miquel, SÁNCHEZ ANTOLÍN, Gloria, LLADÓ GARRIGA, Laura, OTERO FERREIRO, Alejandra, SERRANO, Trinidad, JIMÉNEZ ROMERO, Carlos, GARCÍA GONZÁLEZ, Miguel, VALDIVIESO, Andrés, GONZÁLEZ DIÉGUEZ, María luisa, MATA, Manuel de la, PONS, José a., SALCEDO, Magdalena, RODRIGO, Juan m., CUERVAS MONS, Valentín, GONZÁLEZ RODRÍGUEZ, Antonio, CARALT, Mireia, PARDO, Fernando, VARO PÉREZ, Evaristo, CRESPO CONDE, Gonzalo, RUBIN, Ángel, GUILERA SARDÀ, Magda, ALDEA, Anna, SANTOYO, Julio. Everolimus plus minimized tacrolimus on kidney function in liver transplantation: REDUCE, a prospective, randomized controlled study. _Revista Española de Enfermedades Digestivas_. 2022. [consulta: 21 de gener de 2026]. ISSN: 1130-0108. [Disponible a: https://hdl.handle.net/2445/187444]

Exportar metadades

JSON - METS

Compartir registre