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

Autor: Fernandez Rivera C; Nephrology Department, University Hospital A Coruña, A Coruña, Spain., Calvo Rodríguez M; Nephrology Department, University Hospital A Coruña, A Coruña, Spain., Poveda JL; Pharmacy Department, University Hospital La Fe, Valencia, Spain., Pascual J; Nephrology Department, University Hospital del Mar, Barcelona, Spain., Crespo M; Nephrology Department, University Hospital del Mar, Barcelona, Spain., Gomez G; Nephrology Department, University Hospital Son Espases, Palma de Mallorca, Spain., Cabello Pelegrin S; Nephrology Department, University Hospital Son Espases, Palma de Mallorca, Spain., Paul J; Nephrology Department, Hospital Miguel Servet, Zaragoza, Spain., Lauzurica R; Nephrology Department, University Hospital Germans Trias y Pujol, Badalona, Spain., Perez Mir M; Nephrology Department, University Hospital Germans Trias y Pujol, Badalona, Spain., Moreso F; University Hospital Vall d'Hebron, Department of Medicine, Universitat Autònoma de Barcelona, Nephrology Department, Barcelona, Spain., Perelló M; University Hospital Vall d'Hebron, Department of Medicine, Universitat Autònoma de Barcelona, Nephrology Department, Barcelona, Spain., Andres A; Nephrology Department, University Hospital Doce de Octubre, Madrid, Spain., González E; Nephrology Department, University Hospital Doce de Octubre, Madrid, Spain., Fernandez A; Nephrology Department, University Hospital Ramón y Cajal, Madrid, Spain., Mendiluce A; Nephrology Department, University Hospital Clínico de Valladolid, Valladolid, Spain., Fernández Carbajo B; Nephrology Department, University Hospital Clínico de Valladolid, Valladolid, Spain., Sanchez Fructuoso A; Nephrology Department, University Hospital Clínico San Carlos, Madrid, Spain., Calvo N; Nephrology Department, University Hospital Clínico San Carlos, Madrid, Spain., Suarez A; Nephrology Department, University Hospital Virgen del Rocio, Sevilla, Spain., Bernal Blanco G; Nephrology Department, University Hospital Virgen del Rocio, Sevilla, Spain., Osuna A; Nephrology Department, University Hospital Virgen de las Nieves, Granada, Spain., Ruiz-Fuentes MC; Nephrology Department, University Hospital Virgen de las Nieves, Granada, Spain., Melilli E; Nephrology Department, University Hospital Bellvitge, Hospitalet de Llobregat, Spain., Montero Perez N; Nephrology Department, University Hospital Bellvitge, Hospitalet de Llobregat, Spain., Ramos A; Nephrology Department, Fundación Jiménez Díaz, Madrid, Spain., Fernández B; Nephrology Department, Fundación Jiménez Díaz, Madrid, Spain., López V; University Hospital Regional, Málaga, IBIMA, University of Málaga, REDinREN (RED16/0009/0006), Nephrology Department, Spain., Hernandez D; University Hospital Regional, Málaga, IBIMA, University of Málaga, REDinREN (RED16/0009/0006), Nephrology Department, Spain.
Jazyk: angličtina
Zdroj: Clinical transplantation [Clin Transplant] 2022 Mar; Vol. 36 (3), pp. e14550. Date of Electronic Publication: 2021 Dec 17.
DOI: 10.1111/ctr.14550
Abstrakt: 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.
(© 2021 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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