Bioavailability of once‐daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study. Issue 3 (17th December 2021)

• Record Type: Journal Article
• Authors: Fernandez Rivera, Constantino; Calvo Rodríguez, María; Poveda, José Luís; Pascual, Julio; Crespo, Marta; Gomez, Gonzalo; Cabello Pelegrin, Sheila; Paul, Javier; Lauzurica, Ricardo; Perez Mir, Mònica; Moreso, Francesc; Perelló, Manel; Andres, Amado; González, Esther; Fernandez, Ana; Mendiluce, Alicia; Fernández 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; Fernández, Beatriz; López, Verónica; Hernandez, Domingo
• Is Part Of: Clinical transplantation. Volume 36:Issue 3(2022)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2021-12-17
• Subjects: bioavailability -- clinical practice -- pharmacokinetics -- renal transplantation -- tacrolimus -- treatment failure; Transplantation of organs, tissues, etc -- Periodicals; 617.95
• DOI: 10.1111/ctr.14550
• Languages: English
• ISSNs: 0902-0063

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 (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 at preventing allograft rejection, comparable effect on renal function, safety, adherence, treatment failure and premature discontinuation rates.