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Population Pharmacokinetics and Exploratory Exposure-Response Relationships of Diazepam in Children Treated for

Lawrence C Ku1,2, Christoph P Hornik1,2, Ryan J Beechinor3

  • 1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.

CPT: Pharmacometrics & Systems Pharmacology
|September 30, 2018
PubMed

Insights

This study developed a pharmacokinetic model for intravenous diazepam in pediatric patients with status epilepticus (SE). The findings suggest the study dose more effectively and rapidly achieves therapeutic drug concentrations compared to standard dosing.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Clinical Pharmacy

Background:

  • Status epilepticus (SE) in children requires effective treatment, with diazepam being a labeled option.
  • Limited pharmacokinetic (PK) data exist for intravenous (i.v.) diazepam in pediatric populations.
  • Understanding diazepam disposition is crucial for optimizing SE treatment in children.

Purpose of the Study:

  • To develop a population pharmacokinetic (PK) model for i.v. diazepam in pediatric patients experiencing SE.
  • To assess the relationship between diazepam PK parameters and clinical safety and efficacy.
  • To simulate drug exposures based on different dosing regimens.

Main Methods:

  • A population PK model was developed using data from a prospective pediatric clinical trial.
  • Data included 162 diazepam concentrations from 87 patients (3 months to <18 years).
  • A two-compartment model, scaled by body size, characterized diazepam PKs.

Main Results:

  • Diazepam disposition in pediatric SE was well-described by a body-size-scaled two-compartment model.
  • No significant correlations were found between PK parameters and safety or efficacy outcomes.
  • Simulations indicated the study dose (0.2 mg/kg i.v.) achieved target therapeutic ranges (200-600 ng/mL) more frequently and rapidly than label dosing.

Conclusions:

  • The developed population PK model accurately characterizes diazepam disposition in pediatric SE.
  • The study dose of diazepam demonstrates improved therapeutic concentration achievement compared to label dosing.
  • Further research may refine pediatric diazepam dosing strategies for status epilepticus.

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