Artículo
Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study
Autor/es | Fernandez Rivera, Constantino
Calvo Rodríguez, María Poveda, José Luís Crespo, Marta Gomez, Gonzalo Cabello Pelegrin, Sheila Fernández Rodríguez, Ana Hernandez, Domingo |
Departamento | Universidad de Sevilla. Departamento de Citología e Histología Normal y Patológica |
Fecha de publicación | 2022 |
Fecha de depósito | 2022-11-24 |
Publicado en |
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Resumen | 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 ... 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. |
Cita | Fernandez Rivera, C., Calvo Rodríguez, M., Poveda, J.L., Crespo, M., Gomez, G., Cabello Pelegrin, S.,...,Hernandez, D. (2022). Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study. Clinical Transplantation, 36 (3), e14550. https://doi.org/10.1111/ctr.14550. |
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