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. 2024 Dec;64(12):1491-1504.
doi: 10.1002/jcph.6108. Epub 2024 Aug 9.

Pharmacokinetics of Dexamethasone in Children and Adolescents with Obesity

Collaborators, Affiliations

Pharmacokinetics of Dexamethasone in Children and Adolescents with Obesity

Jiali Wen et al. J Clin Pharmacol. 2024 Dec.

Abstract

Dexamethasone is a synthetic glucocorticoid approved for treating disorders of various organ systems in both adult and pediatric populations. Currently, approved pediatric dosing recommendations are weight-based, but it is unknown whether differences in dexamethasone drug disposition and exposure exist for children with obesity. This study aimed to develop a population pharmacokinetic (PopPK) model for dexamethasone with data collected from children with obesity. Dexamethasone was given as either IV or oral/enteral administration, and a salt factor correction was used for dexamethasone sodium phosphate injection. A PopPK analysis using dexamethasone plasma concentration versus time was performed using the software NONMEM. A virtual population of 1000 children with obesity across three age groups was generated for dosing simulations. Data from 59 study participants with 82 PK plasma samples were used in the PopPK analysis. A one-compartment model with first-order absorption and the inclusion of total body weight as a covariate characterized the data. No other covariates were included in the PopPK model. Single and multiple IV dose(s) of 0.5 and 1 mg/kg every 8 h resulted in 68% or more of virtual children with obesity attaining simulated exposures that were within exposure ranges previously reported in adult studies. In conclusion, this was the first study to characterize dexamethasone's PopPK in children with obesity. Simulation results suggest that virtual children with obesity receiving oral doses of 0.5 and 1 mg/kg had generally comparable dexamethasone exposures as adult estimates. Additional studies are needed to characterize the dexamethasone's target exposure in children.

Keywords: children; dexamethasone; obesity; pharmacokinetics.

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Conflict of interest statement

SJB receives support from the National Institutes of Health, the US Food and Drug Administration, the Patient-Centered Outcomes Research Institute, the Childhood Arthritis and Rheumatology Research Alliance, Purdue Pharma, and consulting for UCB and Rutgers University. The remaining authors have no relevant conflicts of interest to disclose.

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