Improved Medication Adherence with the Use of Extended-Release Tacrolimus in Liver Transplant Recipients: A Pilot Randomized Controlled Trial. (4th January 2023)

• Record Type: Journal Article
• Authors: Verma, Manisha; Zaki, Radi; Sadeh, Johnathan; Knorr, John P.; Gallagher, Mark; Parsikia, Afshin; Navarro, Victor
• Other Names: Williams Trevor Academic Editor.
• Is Part Of: Journal of transplantation. Volume 2023(2023)
• Publication Date: 2023-01-04
• Subjects: Transplantation of organs, tissues, etc -- Periodicals; 617.95405
• DOI: 10.1155/2023/7915781
• Languages: English
• ISSNs: 2090-0007

Abstract

Abstract : Background . Nonadherence to immunosuppression in liver transplant recipients (LTRs) leads to deterioration in health outcomes. Once-dailyextended-release tacrolimus (TAC-ER) may improve adherence when compared to twice-dailyimmediate-release tacrolimus (TAC-IR). Methods . We conducted a randomized controlled study to evaluate medication adherence, clinical efficacy, and safety of TAC-ER in stable LTR. All patients >18 years who underwent liver transplantation before 6 months were eligible. Patients were randomized 1 : 1 to continued TAC-IR or conversion to TAC-ER. The primary outcome was change in medication adherence from baseline to 9 months, assessed using BAASIS. Secondary outcomes were tacrolimus trough levels, safety, and quality of life. Results . Thirty-one patients were consented and randomized to either of the two groups: conversion to TAC-ER ( n = 15) or continued TAC-IR ( n = 16). Six patients in the TAC-ER group withdrew after randomization due to apprehension about switching medication ( n = 2), unwillingness to travel ( n = 2), and increased liver tests after conversion ( n = 2, both were acute rejections despite therapeutic tacrolimus levels and were considered unrelated to TAC-ER). We compared the results of nine patients in the TAC-ER group that completed the study with those of sixteen in the TAC-IR group. At baseline, there was no difference in tacrolimus trough levels between groups. Improved adherence was observed in the TAC-ER group as 100% of patients reported at least one period of full adherence during the study period (100% vs. 62.6%, p = 0.035 ). Tacrolimus trough levels and liver tests were comparable between groups throughout the study. There were no differences in eGFR, HbA1c, or QoL between the groups. Conclusion . TAC-ER improved medication adherence while maintaining comparable trough levels, liver function, and QoL as TAC-IR in LTR.