RT Journal Article
T1 Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.
A1 Fernandez-Rivera, Constantino
A1 Calvo-Rodriguez, Maria
A1 Poveda, Jose Luis
A1 Pascual, Julio
A1 Crespo, Marta
A1 Gomez, Gonzalo
A1 Cabello-Pelegrin, Sheila
A1 Paul, Javier
A1 Lauzurica, Ricardo
A1 Perez-Mir, Monica
A1 Moreso, Francesc
A1 Perello, Manel
A1 Andres, Amado
A1 Gonzalez, Esther
A1 Fernandez, Ana
A1 Mendiluce, Alicia
A1 Fernandez-Carbajo, Beatriz
A1 Sanchez-Fructuoso, Ana
A1 Calvo, Natividad
A1 Suarez, Alejandro
A1 Bernal-Blanco, Gabriel
A1 Osuna, Antonio
A1 Ruiz-Fuentes, M Carmen
A1 Melilli, Edoardo
A1 Montero-Perez, Nuria
A1 Ramos, Ana
A1 Fernandez, Beatriz
A1 Lopez, Veronica
A1 Hernandez, Domingo
K1 bioavailability
K1 clinical practice
K1 pharmacokinetics
K1 renal transplantation
K1 tacrolimus
K1 treatment failure
AB 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 (Cmin /total daily dose [TDD]) vs. PR-Tac (61% increase; P <.001) with similar Cmin 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 in preventing allograft rejection, comparable effects on renal function, safety, adherence, treatment failure, and premature discontinuation rates.
PB John Wiley & Sons
YR 2021
FD 2021-11-13
LK http://hdl.handle.net/10668/19932
UL http://hdl.handle.net/10668/19932
LA en
NO Fernandez Rivera C, Calvo Rodríguez M, Poveda JL, Pascual J, Crespo M, Gomez G, et al. Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study. Clin Transplant. 2022 Mar;36(3):e14550
DS RISalud
RD Apr 7, 2025