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

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<0.001) with similar Cmin and 30% lower TDD levels (p<0.0001). The incidence of treatment failure was 3.9% in the LCPT group and 9.0% in the PR-Tac group (p = 0.117). Study discontinuation rates were 6.2% in the LCPT group and 12.4% in the PR-Tac group (p = 0.113). 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. This article is protected by copyright. All rights reserved.