Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients

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...

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Detalles Bibliográficos
Autores: Fernandez Rivera, Constantino|||0000-0003-2801-6752, Calvo-Rodriguez, Maria, Poveda, José Luís, Pascual, Julio|||0000-0002-4735-7838, Crespo, Marta|||0000-0001-6992-6379, Gomez, Gonzalo, Cabello Pelegrín, Sheila|||0000-0001-9319-6935, Paul, Javier, Lauzurica, Ricardo|||0000-0002-8051-5199, Perez Mir, Mònica, Moreso, Francesc|||0000-0002-7267-3963, Perelló, Manel|||0000-0003-1859-5279, Andres, Amado, González, Esther, Fernández Sánchez, Ana|||0000-0002-0333-1345, Mendiluce, Alicia, Fernández Carbajo, Beatriz, Sánchez Fructuoso, Ana Isabel|||0000-0001-7017-9729, Calvo, Natividad, Suarez, Alejandro, Bernal Blanco, Gabriel, Osuna, Antonio, Ruiz-Fuentes, M. Carmen, Melilli, Edoardo|||0000-0001-6965-3745, Montero, Nuria|||0000-0002-5123-4603, Ramos, Ana, Fernández, Beatriz, López Jiménez, Verónica|||0000-0002-1793-7065, Hernandez, Domingo
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:282451
Acceso en línea:https://ddd.uab.cat/record/282451
https://dx.doi.org/urn:doi:10.1111/ctr.14550
Access Level:acceso abierto
Palabra clave:Bioavailability
Clinical practice
Pharmacokinetics
Renal transplantation
Tacrolimus
Treatment failure
Descripción
Sumario: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.

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