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KMID : 0371420231050040228
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Annals of Surgical Treatment and Research
2023 Volume.105 No. 4 p.228 ~ p.236
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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
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Kim Jae-Yoon
Chang Su-Kyoung
Kim Ji-Young
Choi Hyun-Hwa
Lee Jae-Won
Hong Su-Young
Lee Jeong-Moo
Hong Suk-Kyun
Choi Young-Rok
Yi Nam-Joon
Lee Kwang-Woong
Suh Kyung-Suk
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Abstract
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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.
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KEYWORD
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Efficacy, Immunosuppression therapy, Liver transplantation, Tacrolimus
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