Population pharmacokinetic analysis of tacrolimus in the first year after pediatric liver transplantation.

Purposes: Tacrolimus (TAC) is the most widely used immunosuppressant for the prevention of acute rejection after solid organ transplantation. Its pharmacokinetics (PK) show considerable variability, making TAC a good candidate for therapeutic drug monitoring (TDM). The principal aim of the study was...

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Publicado en:European Journal of Clinical Pharmacology Vol. 69; no. 8; pp. 1533 - 1543
Autores principales: Guy-Viterbo, V., Scohy, A., Verbeeck, R., Reding, R., Wallemacq, P., Musuamba, Flora
Formato: equations & formulas research tables/charts Journal Article
Publicado: Springer Nature Aug2013
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Aug2013
      vid: 69
      iid: 8
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      pub: Springer Nature
      place: New York, New York
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        10.1007/s00228-013-1501-0
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        atl: Population pharmacokinetic analysis of tacrolimus in the first year after pediatric liver transplantation.
      aug:
        au:
          Guy-Viterbo, V.
          Scohy, A.
          Verbeeck, R.
          Reding, R.
          Wallemacq, P.
          Musuamba, Flora
        affil: Louvain Center for Toxicology and Applied Pharmacology, Université catholique de Louvain, Brussels Belgium
      sug:
        subj:
          Antibiotics, Macrolide Pharmacokinetics
          Liver Transplantation In Infancy and Childhood
          Drug Monitoring
          Human
          Child
          Models, Theoretical
          Retrospective Design
          Infant
          Child, Preschool
          Descriptive Statistics
          Data Analysis Software
          Confidence Intervals
          Goodness of Fit Chi Square Test
          Child: 6-12 years
          Infant: 1-23 months
          Child, Preschool: 2-5 years
      ab: Purposes: Tacrolimus (TAC) is the most widely used immunosuppressant for the prevention of acute rejection after solid organ transplantation. Its pharmacokinetics (PK) show considerable variability, making TAC a good candidate for therapeutic drug monitoring (TDM). The principal aim of the study was to describe the PK of TAC in pediatric patients during the first year after transplantation. Methods: Routine TDM trough levels of TAC were obtained from 42 pediatric liver allograft recipients during the first year after transplantation. A population PK model was developed using nonlinear mixed-effects modeling to describe TAC PK during this period and to explain the observed variability by means of patients' demographics, biochemical test results and physiological characteristics. Results: The PK of TAC were best described by a two-compartment model with first-order elimination. Apparent volumes of the central compartment, intercomparmental clearance and maximum blood clearance estimates were 253 L, 115 L/day and 314 L/day, respectively. The absorption first-order rate and volume of peripheral compartment were fixed to 4.5 h and 100 L, respectively. While hematocrit levels, time after transplantation and bodyweight influenced TAC clearance, bodyweight was the only covariate retained on volume of distribution. Conclusions: We developed a TAC population PK model in pediatrics covering the first year after liver transplantation that may serve as a tool for TAC dose individualization as part of TDM.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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