Comparative Study of 2 Extended-Release Tacrolimus Formulations in Kidney Transplantation

• Published in: Transplantation proceedings Vol. 54; no. 9; pp. 2434 - 2438
• Main Authors: Cholbi Vives, Ester, Espí Reig, Jordi, Cruz Sánchez, Andrés, Moreno Maestre, Elena, Ventura Galiano, Ana, Ramos Escorihuela, David, Ramos Cebrián, María, González-Calero Borrás, Pablo, Beneyto Castelló, Isabel, Hernández Jaras, Julio
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2022
• Subjects: Delayed-Action Preparations; Drugs, Generic - adverse effects; Graft Rejection - epidemiology; Humans; Immunosuppressive Agents - adverse effects; Kidney Transplantation - adverse effects; Prospective Studies; Tacrolimus - adverse effects
• ISSN: 0041-1345; 1873-2623
• DOI: 10.1016/j.transproceed.2022.10.001

•Tacrolimus is the mainstay immunosuppressive agent to prevent kidney graft rejection.•Tacrolimus extended-release formulation emerged to improve adherence•Generic extended-release formulations are also a guarantee of efficacy and safety.•Generic and reference tacrolimus show similar behaviors and results. During the 1900s, tacrolimus became the mainstay immunosuppressive agent to prevent rejection after kidney transplant. Subsequently, an extended-release tacrolimus (ER-Tac) formulation was developed to improve adherence, and its generic version has been marketed over the last years. This study examines the differences in efficacy and safety between the generic ER-Tac (Conferoport) and the reference brand-name drug (Advagraf). Prospective, randomized and parallel single-center study (May 2020 to June 2021) with 52 kidney transplant recipients who were randomly assigned to 1 of the following groups: study group (Conferoport, n = 31) and control group (Advagraf, n = 21). The variables of interest were collected and analyzed to compare tacrolimus efficacy and safety between them. Demographic characteristics of the patients and clinical donor data were homogeneous in both groups (P > .05). No statistically significant differences were found among treatments regarding dosage used, levels, creatinine, and proteinuria (P > .05), with these variables presenting a downward trend during follow-up and, consequently, the improvement of graft function. Analyses also revealed the absence of differences concerning the incidence of acute rejection and intrapatient variability (coefficient of variation) throughout the first year of evolution between both formulations (P > .05). A total of 5 graft losses occurred, 2 resulting from patient death. In our experience, we found no significant differences between the measured parameters in relation to the efficacy and safety profile of both drugs, with generic ER-Tac being an alternative comparable with the reference brand-name ER-Tac.