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

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, Calvo Rodriguez, Maria, Poveda, Jose Luis, Pascual, Julio, Crespo, Marta, Gomez, Gonzalo, Cabello Pelegrin, Sheila, Paul, Javier, Lauzurica, Ricardo, Perez Mir, Monica, Moreso, Francesc, Perello, Manel, Andres Cano, Ignacio, Gonzalez, Esther, Fernandez, Ana, Mendiluce, Alicia, Fernandez Carbajo, Beatriz, Sanchez Fructuoso, Ana, Calvo, Natividad, Suarez, Alejandro, Bernal Blanco, Gabriel, Osuna, Antonio, Ruiz-Fuentes, M. Carmen, Melilli, Edoardo, Montero Perez, Nuria, Ramos, Ana, Fernandez, Beatriz, Lopez, Veronica, Hernandez, Domingo, Better Study
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/19467
Acceso en línea:https://hdl.handle.net/20.500.13003/19467
Access Level:acceso abierto
Palabra clave:Immunosuppressive Agents
Kidney Transplantation
Prospective Studies
Graft Rejection
Tacrolimus
Biological Availability
Drug Administration Schedule
Humans
Transplant Recipients
Receptores de Trasplantes
Esquema de Medicación
Disponibilidad Biológica
Humanos
Estudios Prospectivos
Inmunosupresores
Rechazo de Injerto
Trasplante de Riñón
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-min /total daily dose [TDD]) vs. PR-Tac (61% increase; P < .001) with similar C-min 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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