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- Title
Conversion from twice- to once-daily tacrolimus in pediatric kidney recipients: a pharmacokinetic and bioequivalence study.
- Authors
Lapeyraque, Anne-Laure; Kassir, Nastya; Théorêt, Yves; Krajinovic, Maja; Clermont, Marie-José; Litalien, Catherine; Phan, Véronique
- Abstract
Background: The objectives of this study were to investigate pharmacokinetic and pharmacogenetic parameters during the conversion on a 1:1 (mg:mg) basis from a twice-daily (Prograf) to once-daily (Advagraf) tacrolimus formulation in pediatric kidney transplant recipients. Methods: Twenty-four-hour pharmacokinetic profiles were analyzed before and after conversion in 19 stable renal transplant recipients (age 7-19 years). Tacrolimus pharmacokinetic parameters [area under the concentration-time curve (AUC), minimum whole-blood concentration (C), maximum whole-blood concentration (C), and time to achieve maximum whole-blood concentration (t)] were compared between Tac formulations and between CYP3A5 and MDR1 genotypes after dose normalization. Results: Both AUC and C decreased after conversion (223.3 to 197.5 ng.h/ml and 6.5 to 5.6 ng/ml; p = 0.03 and 0.01, respectively). However, the ratio of the least square means (LSM) for AUC was 90.8 %, with 90 % CI limits of 85.3 to 96.7 %, falling within bioequivalence limits. The CYP3A5 genotype influences the dose-normalized C with the twice-daily formulation only. Conclusions: Both tacrolimus formulations are bioequivalent in pediatric renal recipients. However, we observed a decrease in AUC and C after the conversion, requiring close pharmacokinetic monitoring during the conversion period.
- Subjects
QUEBEC (Province); BIOLOGICAL assay; CONFIDENCE intervals; TACROLIMUS; GENES; KIDNEY transplantation; PEDIATRICS; PHARMACEUTICAL chemistry; RESEARCH funding; T-test (Statistics); U-statistics; DATA analysis software; DESCRIPTIVE statistics
- Publication
Pediatric Nephrology, 2014, Vol 29, Issue 6, p1081
- ISSN
0931-041X
- Publication type
Article
- DOI
10.1007/s00467-013-2724-0