1일 2회 투여하는 Tacrolimus에서 1일 1회 투여하는 서방형 Tacrolimus로 전환 시 대응 용량비의 적절성 평가 (Evaluation of the Adequacy of the Dosage Conversion Ratio in Switching from Twice-Daily Tacrolimus to Once-Daily Extended-Release Tacrolimus)

서지정보

· 발행기관 : 한국병원약사회
· 수록지 정보 : 병원약사회지 / 37권 / 1호 / 43 ~ 53페이지
· 저자명 : 김혜영, 박소연, 오미란, 이성민, 윤정이, 권은영, 황보신이

초록

Background and purpose : Tacrolimus commonly used in immunosuppressants is generally administered twice daily, but can be switched to once daily extended-release formulation for increasing patient adherence. When switching from twice-daily tacrolimus to once-daily extended-release tacrolimus, a total daily dosage conversion ratio is recommended at 1:1 by the Ministry of Food and Drug Safety. But some studies have shown that the tacrolimus trough levels decreased at the 1:1 conversion. Accordingly, the purpose of this study was to evaluate the adequacy of the dosage conversion ratio in patients switched from twice-daily tacrolimus to once-daily extended-release.
Methods : This was a retrospective and single center study that was conducted June 2016-June 2017. The medical records such as total daily dose, tacrolimus trough levels, and blood test results were analyzed on patients switched from a twice-daily tacrolimus to a once-daily extended-release tacrolimus for either kidney or liver transplantation.
Results : Among a total of 50 patients, there were 36 patients in the 1:1 dosage conversion ratio group, four patients in the decreased dosage ratio group, and 10 patients in the increased dosage ratio group. The increased ratio subgroup analysis was conducted by dividing into less than 1.5 times (<1.5 group, n=5) and more than 1.5 times (≥1.5 group, n=5) depending on the range of dosage conversion ratio. The pre- and post-conversion tacrolimus trough levels significantly decreased 5.3±1.7 ng/ml-3.7±1.2 ng/ml in the 1:1 group (p <0.001). And tacrolimus trough levels in the <1.5 group decreased 4.5±2.3 ng/ml-4.2±1.4 ng/ml and in the ≥1.5 group increased 3.1±1.2 ng/ml-4.8±2.6 ng/ml (p=0.625, p=0.125).
The mean of changes in tacrolimus trough level (|pre-post|) was 1.7±1.6 ng/ml in the 1:1 group, 1.0±0.7 ng/ml in the <1.5 group and 1.6±1.5 ng/ml in the ≥1.5 group. Among these, the <1.5 group was the smallest.
Conclusion : The tacrolimus trough level significantly decreased in patients who converted to a 1:1 dosage conversion ratio from twice-daily tacrolimus to once-daily extended release tacrolimus. Thus, switching to a dosage conversion ratio of less than 1.5 times may facilitate the maintenance of a constant tacrolimus trough level before and after the conversion than 1:1 conversion.

영어초록

Background and purpose : Tacrolimus commonly used in immunosuppressants is generally administered twice daily, but can be switched to once daily extended-release formulation for increasing patient adherence. When switching from twice-daily tacrolimus to once-daily extended-release tacrolimus, a total daily dosage conversion ratio is recommended at 1:1 by the Ministry of Food and Drug Safety. But some studies have shown that the tacrolimus trough levels decreased at the 1:1 conversion. Accordingly, the purpose of this study was to evaluate the adequacy of the dosage conversion ratio in patients switched from twice-daily tacrolimus to once-daily extended-release.
Methods : This was a retrospective and single center study that was conducted June 2016-June 2017. The medical records such as total daily dose, tacrolimus trough levels, and blood test results were analyzed on patients switched from a twice-daily tacrolimus to a once-daily extended-release tacrolimus for either kidney or liver transplantation.
Results : Among a total of 50 patients, there were 36 patients in the 1:1 dosage conversion ratio group, four patients in the decreased dosage ratio group, and 10 patients in the increased dosage ratio group. The increased ratio subgroup analysis was conducted by dividing into less than 1.5 times (<1.5 group, n=5) and more than 1.5 times (≥1.5 group, n=5) depending on the range of dosage conversion ratio. The pre- and post-conversion tacrolimus trough levels significantly decreased 5.3±1.7 ng/ml-3.7±1.2 ng/ml in the 1:1 group (p <0.001). And tacrolimus trough levels in the <1.5 group decreased 4.5±2.3 ng/ml-4.2±1.4 ng/ml and in the ≥1.5 group increased 3.1±1.2 ng/ml-4.8±2.6 ng/ml (p=0.625, p=0.125).
The mean of changes in tacrolimus trough level (|pre-post|) was 1.7±1.6 ng/ml in the 1:1 group, 1.0±0.7 ng/ml in the <1.5 group and 1.6±1.5 ng/ml in the ≥1.5 group. Among these, the <1.5 group was the smallest.
Conclusion : The tacrolimus trough level significantly decreased in patients who converted to a 1:1 dosage conversion ratio from twice-daily tacrolimus to once-daily extended release tacrolimus. Thus, switching to a dosage conversion ratio of less than 1.5 times may facilitate the maintenance of a constant tacrolimus trough level before and after the conversion than 1:1 conversion.

참고자료

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