%0 Journal Article
%A Fernandez-Rivera, Constantino
%A Calvo-Rodriguez, Maria
%A Poveda, Jose Luis
%A Pascual, Julio
%A Crespo, Marta
%A Gomez, Gonzalo
%A Cabello-Pelegrin, Sheila
%A Paul, Javier
%A Lauzurica, Ricardo
%A Perez-Mir, Monica
%A Moreso, Francesc
%A Perello, Manel
%A Andres, Amado
%A Gonzalez, Esther
%A Fernandez, Ana
%A Mendiluce, Alicia
%A Fernandez-Carbajo, Beatriz
%A Sanchez-Fructuoso, Ana
%A Calvo, Natividad
%A Suarez, Alejandro
%A Bernal-Blanco, Gabriel
%A Osuna, Antonio
%A Ruiz-Fuentes, M Carmen
%A Melilli, Edoardo
%A Montero-Perez, Nuria
%A Ramos, Ana
%A Fernandez, Beatriz
%A Lopez, Veronica
%A Hernandez, Domingo
%T Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.
%D 2021
%U http://hdl.handle.net/10668/19932
%X 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.
%K bioavailability
%K clinical practice
%K pharmacokinetics
%K renal transplantation
%K tacrolimus
%K treatment failure
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