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Makiko Shimizu1, Shotaro Uehara2, Katsuhiro Ohyama3

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Drug Metabolism and Disposition: the Biological Fate of Chemicals
|October 25, 2023
PubMed
Summary

This study developed pharmacokinetic models to predict atomoxetine levels in children. A metabolite ratio may help identify CYP2D6 intermediate metabolizers for optimized ADHD treatment.

Keywords:
CYP2D6human CYP enzymespharmacogeneticspharmacokinetic modeling

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Area of Science:

  • Pharmacology
  • Pharmacokinetics
  • Drug Metabolism

Background:

  • Atomoxetine is an ADHD medication and a CYP2D6 probe substrate.
  • Drug interactions and individual metabolic differences impact atomoxetine efficacy and safety.
  • Accurate dosing requires understanding CYP2D6 enzyme activity.

Purpose of the Study:

  • To develop and validate human physiologically based pharmacokinetic (PBPK) models for atomoxetine in pediatric patients.
  • To investigate drug interactions between atomoxetine and paroxetine using humanized-liver mouse models.
  • To identify simple methods for determining CYP2D6 phenotypes in pediatric populations.

Main Methods:

  • Utilized humanized-liver mouse studies to observe drug interactions.
  • Established human PBPK models by scaling up mouse data.
  • Validated models against drug monitoring data from Japanese pediatric participants (8-14 years).

Main Results:

  • PBPK models accurately predicted atomoxetine and its metabolite concentrations in pediatric patients.
  • High hepatic exposure in potential intermediate metabolizers (CYP2D6*10, *36 alleles) may explain adverse effects.
  • A narrow ratio of 4-hydroxyatomoxetine to N-desmethylatomoxetine may indicate CYP2D6 intermediate metabolizers.

Conclusions:

  • Validated pharmacokinetic models can predict atomoxetine steady-state concentrations in children.
  • A simple metabolite ratio in urine/plasma could serve as a semi-quantitative marker for CYP2D6 intermediate metabolizers.
  • This approach may aid in optimizing atomoxetine dosage and evaluating clinical outcomes.