Bioavailability of once‐daily tacrolimus formulations used in clinical practice in the management of <i>De Novo</i> kidney transplant recipients: the better study
Constantino Fernández Rivera, María Calvo Rodríguez, José Luís Poveda, Julio Pascual, Marta Crespo, Gonzalo Gómez, Sheila Cabello Pelegrín, Javier Paúl, Ricardo Lauzurica, Mònica Pérez Mir, Francesc Moreso, Manel Perelló, Amado Andrés, Esther González, Ana Fernández, Alicia Mendiluce, Beatriz Fernández Carbajo, Ana Sánchez‐Fructuoso, Natividad Calvo, A. Suarez, Gabriel Bernal Blanco, Antonio Osuna, María Carmen Ruiz-Fuentes, Edoardo Melilli, Núria Montero Pérez, Ana Ramos, Beatriz Fernández, Verónica López, Domingo Hernández, the Better study
Abstract
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 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.