Ann Surg Treat Res.  2023 Oct;105(4):228-236. 10.4174/astr.2023.105.4.228.

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

• Kim JY
• Chang S
• Kim J
• Choi HH
• Lee J
• Hong Sy
• Lee JM
• Hong SK
• Choi Y
• Yi NJ
• Lee KW
• Suh KS

• KMID: 2546785
• DOI: http://doi.org/10.4174/astr.2023.105.4.228

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.

Keyword

Efficacy; Immunosuppression therapy; Liver transplantation; Tacrolimus

Figure

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  Fig. 1 Study design. Lab, laboratory results; BMI, body mass index; CBC, complete blood count; HbA1C, hemoglobin A1C; sCr, serum creatinine; Meds, medications; eGFR, estimated glomerular filtration rate; AE, adverse effect.

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  Fig. 2 Mean trough levels and total daily dose (TDD) of tacrolimus.

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  Fig. 3 Laboratory findings of liver function test. Numbers in the boxes means the patient numbers.

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  Fig. 4 Laboratory findings of estimated glomerular filtration rate (eGFR), serum creatinine (sCr), and hemoglobuin A1C (HbA1C).

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  Fig. 5 Discomfort and satisfaction survey results.

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