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Population pharmacokinetics of theophylline in premature Korean infants

Sung Eun Kim1, Bo-Hyung Kim, Seunghwan Lee

  • 1Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.

Therapeutic Drug Monitoring
|May 14, 2013
PubMed

Insights

This study developed a population pharmacokinetic model for theophylline in premature Korean infants, finding body weight and postnatal age crucial for dose adjustments. The model offers improved accuracy for therapeutic theophylline concentrations.

Area of Science:

  • Pharmacokinetics
  • Pediatric Pharmacology
  • Neonatology

Background:

  • Theophylline is a critical medication for premature infants.
  • Accurate dosing is essential to manage respiratory conditions and minimize toxicity.
  • Population pharmacokinetics (PopPK) models aid in optimizing drug regimens for specific patient populations.

Purpose of the Study:

  • To establish a population pharmacokinetic model for theophylline in premature Korean infants.
  • To identify key clinical covariates influencing theophylline pharmacokinetics.
  • To assess the model's predictive performance for dose optimization.

Main Methods:

  • Collected 334 serum theophylline concentrations from 100 premature infants.
  • Utilized a one-compartment model with first-order elimination in NONMEM.
  • Evaluated covariates including body weight, postnatal age, and CYP1A2 genotypes.
  • Performed external validation with an independent dataset of 27 patients.

Main Results:

  • The final PopPK model incorporated body weight and postnatal age to predict theophylline clearance and volume of distribution.
  • CYP1A2 genotypes did not significantly improve the model's predictive power.
  • External validation confirmed the model's unbiased predictive performance.

Conclusions:

  • The developed theophylline PopPK model provides a reliable tool for dose individualization in premature infants.
  • The model's predictions were acceptable, potentially leading to more precise dosing strategies.
  • Observed higher volume of distribution compared to prior studies, possibly due to sampling strategies.
Abstract

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