Effectiveness and safety of the conversion to MeltDose® extended‐release tacrolimus from other formulations of tacrolimus in stable kidney transplant patients: A retrospective study

• DOI: 10.1111/ctr.13767
• Publication Date: 2019-12-09T10:33:50Z
• Authors: Ana Sánchez Fruct...; Juan Carlos Ruiz; Antonio Franco; Fritz Diekmann; Dolores Redondo; Jesús Calviño; Nuria Serra; María José Aladrén; Secundino Cigarrán; Ana Manonelles; Ana Ramos; Gonzalo Gómez; José Manuel Gonzá...; Amado Andrés; Isabel Beneyto; Andrés López Muñiz; Manel Perelló; Ricardo Lauzurica
• Keywords: *prolonged-release tacrolimus; *tacrolimus; *immediate-release tacrolimus; LCPT, extended-release tacrolimus, immediate-release tacrolimus, kidney transplant, prolonged-release tacrolimus, tacrolimus; Original Articles; *extended-release tacrolimus; Kidney Transplantation; Drug Administration Schedule; Tacrolimus; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Delayed-Action Preparations; Humans; Prospective Studies; *LCPT; Immunosuppressive Agents; *kidney transplant; Retrospective Studies

Tacrolimus is the cornerstone of immunosuppressive therapy after kidney transplantation. Its narrow therapeutic window mandates serum level strict monitoring and dose adjustments to ensure optimal risk-benefit balance. This observational retrospective study analyzed effectiveness safety conversion from twice-daily immediate-release tacrolimus (IR-Tac) or once-daily prolonged-release (PR-Tac) recent formulation MeltDose® extended-release (LCP-Tac) in 365 stable transplant recipients. We compared function three months before conversion. Three conversion, total daily was reduced ~35% (P < .0001), improved bioavailability LCP-Tac concentrations were observed. There no increase number patients requiring Renal unaltered, cases BPAR reported. Reports tremors, as collected clinical histories for each patient, decreased pre-conversion (20.8%) post-conversion (11.8%, P .0001). generated a cost reduction 63% with PR-Tac. In conclusion, strategy other formulations showed real-world setting, confirming data RCTs. The specific pharmacokinetic properties could be potentially advantageous tacrolimus-related adverse events.