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

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 in preventing allograft rejection, comparable effects on renal function, safety, adherence, treatment failure, and premature discontinuation rates.