Evidence map›Paper›PMID 39120865›Full record

ArticleJournal of clinical pharmacology2024

Pharmacokinetics of Dexamethasone in Children and Adolescents with Obesity.

Jiali Wen, Sean McCann, Stephen J Balevic, William J Muller, Chi D Hornik, Julie Autmizguine, Sarah G Anderson, Elizabeth H Payne, Sitora Turdalieva, Daniel Gonzalez and 1 more

Abstract read
In one paragraph

Article in Journal of clinical pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jiali WenDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-9173-9665
Sean McCannDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0003-2723-5398
Stephen J BalevicDuke Clinical Research Institute, Durham, NC, USA.ORCID 0000-0002-4016-1680
William J MullerAnn and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.ORCID 0000-0001-7690-0695
Chi D HornikDepartment of Pediatrics, Duke University Medical Center, Durham, NC, USA.ORCID 0000-0002-7656-3657
Julie AutmizguineDepartment of Pediatrics, Center Hospitalier Universitaire Sainte-Justine, Monetreal, Quebec, Canada.
Sarah G AndersonThe Emmes Company, LLC, Rockville, MD, USA.
Elizabeth H PayneThe Emmes Company, LLC, Rockville, MD, USA.
Sitora TurdalievaThe Emmes Company, LLC, Rockville, MD, USA.
Daniel GonzalezDuke Clinical Research Institute, Durham, NC, USA.ORCID 0000-0001-5522-5686
Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee

Funding

Application of Physiologically-Based Pharmacokinetic Modeling to Characterize Drug-Drug Interactions in InfantsR01HD102949 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Daniel Gonzalez · 2021 to 2026
$3.0M
PRISMR01HD113201 · NICHD · DUKE UNIVERSITY · PI Daniel Gonzalez, Jason E. Lang · 2023 to 2026
$2.7M
Physiologically-Based Pharmacokinetic Modeling to Guide Drug Dosing in Children with ObesityR01HD096435 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DUMOND, JULIE BRUMER · 2018 to 2022
$2.0M
Emmes Company R01HD096435Eunice Kennedy Shriver National Institute of Child Health and Human Development R01HD096435Eunice Kennedy Shriver National Institute of Child Health and Human Development R01HD102949Eunice Kennedy Shriver National Institute of Child Health and Human Development R01HD113201NICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS HHSN275201700002CNICHD NIH HHS HHSN275201800003INICHD NIH HHS R01 HD096435NICHD NIH HHS R01 HD102949NICHD NIH HHS R01 HD113201
6 · The paper itself

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.

Indexed as

DexamethasoneGlucocorticoidsModels, BiologicalAdministration, OralAdolescentChildChild, PreschoolComputer SimulationDose-Response Relationship, DrugFemaleHumansMaleObesityPediatric ObesityDexamethasoneGlucocorticoidschildrendexamethasoneobesitypharmacokinetics

Identifiers

PMID39120865
PMCPMC11598673

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.