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

• DOI: 10.1111/ctr.14550
• Publication Date: 2021-12-01T14:43:32Z
• Authors: Constantino Ferna...; María Calvo Rodrí...; José Luís Poveda; Julio Pascual; Marta Crespo; Gonzalo Gomez; Sheila Cabello Pe...; Javier Paul; Ricardo Lauzurica; Mònica Perez Mir; Francesc Moreso; Manel Perelló; Amado Andres; Esther González; Ana Fernandez; Alicia Mendiluce; Beatriz Fernández...; Ana Sanchez Fruct...; Natividad Calvo; Alejandro Suarez; Gabriel Bernal Bl...; Antonio Osuna; M. Carmen Ruiz‐Fu...; Edoardo Melilli; Nuria Montero Perez; Ana Ramos; Beatriz Fernández; Verónica López; Domingo Hernandez
• Keywords: Graft Rejection; Bioavailability; Biological Availability; Riñón; Clinical practice; Rechazo de Injerto; Drug Administration Schedule; Tacrolimus; Receptores de Trasplantes; 03 medical and health sciences; Equipos de Comunicación para Personas con Discapacidad; 0302 clinical medicine; Humans; Pharmacokinetics; Prospective Studies; tacrolimus; treatment failure; Disponibilidad Biológica; Esquema de Medicación; Renal transplantation; Estudios Prospectivos; Original Articles; renal transplantation; Inmunosupresores; Kidney Transplantation; Transplant Recipients; Humanos; clinical practice; 3. Good health; Trasplante de Riñón; Treatment failure; Dosificación; Trasplantes; bioavailability; pharmacokinetics; Immunosuppressive Agents

AbstractMulticenter, 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.