Effectiveness and safety of once-daily tacrolimus formulations in de novo liver transplant recipients: The PRETHI study.

Autor: Bilbao I; Servicio de Cirugía Hepatobiliopancreática y Trasplantes Digestivos, Hospital Universitario Vall d'Hebron, VHIR, Universidad Autónoma de Barcelona, Barcelona, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain., Gómez Bravo MÁ; Hospital Virgen del Rocío, Sevilla, Spain., Otero A; Hospital de A Coruña, A Coruña, Spain., Lladó L; Hospital U Bellvitge, Hospitalet de Llobregat, Barcelona, Spain., Montero JL; Unidad de hepatología, Hospital U Reina Sofía, Córdoba, Spain., González Dieguez L; Liver Unit, Hospital U Central de Asturias, Oviedo, Spain., Graus J; Hospital Ramón y Cajal, Madrid, Spain., Pons Miñano JA; Liver Transplant Unit, Hospital Virgen de la Arrixaca, IMIB, Murcia, Spain.
Jazyk: angličtina
Zdroj: Clinical transplantation [Clin Transplant] 2023 Dec; Vol. 37 (12), pp. e15105. Date of Electronic Publication: 2023 Aug 24.
DOI: 10.1111/ctr.15105
Abstrakt: Data comparing long-term effectiveness and safety of once-daily tacrolimus formulations in de novo liver transplantation are scarce. We compared the effectiveness, pharmacokinetic profile, and safety of LCPT (Envarsus) and PR-Tac (Advagraf) for up to 12 months post-transplant. Adult de novo liver transplant recipients who started IR-Tac (Prograf) and were converted to LCPT or PR-Tac 3-5 days post-transplant were included. Data from 163 patients were analyzed, 87 treated with LCPT and 76 with PR-Tac. The incidence of treatment failure was 30.5% in the LCPT group versus 23.0% in the PR-Tac group (p = .291). Biopsy-proven acute rejection (BPAR) was reported in 26.8% of patients in the LCPT group and 17.6% in the PR-Tac group (p = .166). Graft loss was experienced in one patient (1.2%) in the LCPT group and three patients (4.1%) in the PR-Tac group (p = .346). Death was registered in three patients (3.7%) in the LCPT group and three patients (4.1%) in the PR-Tac group (p > .999). Patients in the LCPT group showed 45.7% higher relative bioavailability (C min /total daily dose [TDD]; p < .01) with similar C min and 33.3% lower TDD versus PR-Tac (p < .01). The evolution of renal function, safety profile, and the incidence of post-transplant renal failure, dyslipidemia, obesity, hypertension, and diabetes mellitus were similar in patients treated with LCPT and PR-Tac. In de novo liver transplant patients, LCPT and PR-Tac showed comparable effectiveness with higher relative bioavailability, similar C min and lower TDD in the LCPT group. Renal function, safety, and post-transplant complications were comparable in LCPT and PR-Tac groups.
(© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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