Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients : the better study
Fernandez Rivera, Constantino (Complejo Hospitalario Universitario de A Coruña)
Calvo Rodríguez, María (Complejo Hospitalario Universitario de A Coruña)
Poveda, José Luís (Hospital Universitari i Politècnic La Fe (València))
Pascual Santos, Julio (Institut Hospital del Mar d'Investigacions Mèdiques)
Crespo, Marta (Hospital del Mar (Barcelona, Catalunya))
Gomez, Gonzalo (Hospital Universitari Son Espases (Palma de Mallorca, Balears))
Cabello Pelegrin, Sheila (Hospital Universitari Son Espases (Palma de Mallorca, Balears))
Paul, Javier (Hospital Universitario Miguel Servet (Saragossa))
Lauzurica, Ricardo (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Perez Mir, Mònica (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Moreso, Francesc (Hospital Universitari Vall d'Hebron)
Perelló, Manel (Hospital Universitari Vall d'Hebron)
Andres, Amado (Hospital 12 de Octubre (Madrid))
González, Esther (Hospital 12 de Octubre (Madrid))
Fernandez, Ana (Hospital Universitario Ramón y Cajal (Madrid))
Mendiluce, Alicia (Hospital Universitario Clínico de Valladolid)
Fernández Carbajo, Beatriz (Hospital Universitario Clínico de Valladolid)
Sanchez Fructuoso, Ana (Hospital Universitario Clínico San Carlos (Madrid))
Calvo, Natividad (Hospital Universitario Clínico San Carlos (Madrid))
Suarez, Alejandro (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Bernal Blanco, Gabriel (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Osuna, Antonio (Hospital Universitario Virgen de las Nieves (Granada))
Ruiz-Fuentes, M. Carmen (Hospital Universitario Virgen de las Nieves (Granada))
Melilli, Edoardo (Hospital Universitari de Bellvitge)
Montero, Nuria (Hospital Universitari de Bellvitge)
Ramos, Ana (Hospital Universitario Fundación Jiménez Díaz)
Fernández, Beatriz (Hospital Universitario Fundación Jiménez Díaz)
López, Verónica (Universidad de Málaga)
Hernandez, Domingo (Universidad de Málaga)
Universitat Autònoma de Barcelona

Date:	2021
Abstract:	Multicenter, prospective, observational study to compare the relative bioavailability of once-daily tacrolimus formulations in de novo kidney transplant recipients. De novo kidney transplant recipients who started a tacrolimus-based regimen were included 14 days post-transplant and followed up for 6 months. Data from 218 participants were evaluated: 129 in the LCPT group (Envarsus) and 89 in the PR-Tac (Advagraf) group. Patients in the LCPT group exhibited higher relative bioavailability (C /total daily dose [TDD]) vs. PR-Tac (61% increase; P <. 001) with similar C and 30% lower TDD levels (P <. 0001). The incidence of treatment failure was 3. 9% in the LCPT group and 9. 0% in the PR-Tac group (P =. 117). Study discontinuation rates were 6. 2% in the LCPT group and 12. 4% in the PR-Tac group (P =. 113). Adverse events, renal function and other complications were comparable between groups. The median accumulated dose of tacrolimus in the LCPT group from day 14 to month 6 was 889 mg. Compared to PR-Tac, LCPT showed higher relative bioavailability, similar effectiveness at preventing allograft rejection, comparable effect on renal function, safety, adherence, treatment failure and premature discontinuation rates.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Bioavailability ; Clinical practice ; Pharmacokinetics ; Renal transplantation ; Tacrolimus ; Treatment failure
Published in:	Clinical Transplantation, Vol. 36 (december 2021) , ISSN 1399-0012

DOI: 10.1111/ctr.14550
PMID: 34851532

12 p, 983.1 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles