Pharmacokinetic Profile of Twice- and Once-daily Tacrolimus in Pediatric Kidney Transplant Recipients

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• 作者：Y. Takahashi^a ; ^b ; S. Shishido^a ; ^b ; ^{shishido@med.toho-u.ac.jp} ; Y. Hyodo^a ; T. Yonekura^a ; H. Nihei^a ; Y. Itabashi^a ; M. Muramatsu^a ; Y. Hamasaki^b ; T. Kawamura^a ; A. Aikawa^a
• 刊名：Transplantation Proceedings
• 出版年：2017
• 出版时间：January-February 2017
• 年：2017
• 卷：49
• 期：1
• 页码：37-40
• 全文大小：413 K
• 卷排序：49

文摘

The aim of this study was to assess the differences in pharmacokinetic (PK) profiles after the 1:1 ratio-based conversion from a twice-daily to a once-daily tacrolimus formulation (TD-TAC and OD-TAC, respectively) in pediatric recipients of kidney transplants.MethodsTD-TAC was initially administered to 29 pediatric patients who underwent kidney transplantations between April 2010 and September 2015 and were then subsequently switched to OD-TAC. The switch dose ratio was 1:1, and the 24-hour complete PK parameter assessment was performed before and after the regimen was changed from TD-TAC to OD-TAC.ResultsThe mean total daily dose at baseline was 5.5 ± 2.9 mg (0.18 ± 0.10 mg/kg body weight). Consecutive PK studies revealed no significant difference in the mean time to achieve maximum concentrations and the area under the concentration–time curve from 0 to 24 hours (AUC0–24) of both drug formulations. However, the mean trough concentration (Cmin) and the maximum concentration of OD-TAC were 22% and 6% lower and higher, respectively, than those of TD-TAC. Therefore, a better correlation was observed between the AUC0–24 and Cmin of OD-TAC than between those of TD-TAC.ConclusionsAfter the change from TD-TAC to OD-TAC, the AUC0–24 values were equivalent despite a 22% reduction in Cmin. Cmin may therefore be an excellent predictor in the therapeutic drug monitoring of OD-TAC because of its superior correlation with AUC0–24.