Evaluation of the efficacy and safety of conversion from the tacrolimus capsule to tablet in stable liver transplant recipients with maintenance therapy: a 24-week, open-label, single-center, phase IV exploratory clinical study
10.4174/astr.2023.105.4.228
- Author:
Jae-Yoon KIM
1
;
Sukyoung CHANG
;
Jiyoung KIM
;
Hyun Hwa CHOI
;
Jaewon LEE
;
Su young HONG
;
Jeong-Moo LEE
;
Suk Kyun HONG
;
YoungRok CHOI
;
Nam-Joon YI
;
Kwang-Woong LEE
;
Kyung-Suk SUH
Author Information
1. Department of Surgery, Seoul National University College of Medicine, Seoul, Korea
- Publication Type:ORIGINAL ARTICLE
- From:Annals of Surgical Treatment and Research
2023;105(4):228-236
- CountryRepublic of Korea
- Language:English
-
Abstract:
Purpose:The tablet form of tacrolimus is more convenient for drug ingestion than the capsule form. We examined the efficacy and safety of tacrolimus tablets and a satisfaction survey after formula conversion in liver transplant (LT) recipients.
Methods:This study was an open-label, prospective clinical trial for tacrolimus formula 1:1 conversion from capsule to tablet in 41 adult LT recipients with tacrolimus maintenance therapy of more than 1 month. The primary endpoint was incidence of biopsy-proven acute rejection (BPAR) within 24 weeks. Surveys 1 week before and 4 weeks after formula conversion were conducted for total daily dose of medication, number, scale of discomfort and satisfaction.
Results:The overall incidence of BPAR was 0% and there was no graft loss or patient death. The incidence of adverse effects was 34.1% (n = 14) after formula conversion. The most common severe adverse effect was abnormal liver function test (n = 5): biliary complications (n = 4) and alcoholic recidivism (n = 1). Total daily dose and number of tacrolimus doses were significantly lower after formula conversion (P < 0.05) without changes in trough level. According to survey analysis, there was no significant difference in discomfort and satisfaction scales from capsule to tablet conversion (P < 0.05).
Conclusion:The present study suggests that the new tablet formula can be a useful treatment option to maintain a consistent level of tacrolimus with a lower total daily dose and number in adult LT recipients.
