Trial reportThe Journal of pediatrics2018
Obese Children Require Lower Doses of Pantoprazole Than Nonobese Peers to Achieve Equal Systemic Drug Exposures.
Trial report in The Journal of pediatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02186652 (The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.
- The effect of obesity, macronutrients, fasting and nutritional status on drug-metabolizing cytochrome P450s: a systematic review of current evidence on human studies.European journal of nutrition · 2021Pooled it
- Lean body weight dosing avoids excessive systemic exposure to proton pump inhibitors for children with obesity.Pediatric obesity · 2019Trial
- A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator.CPT: pharmacometrics & systems pharmacology · 2024Article
- Evaluation of Obesity-Related Physiological Changes on Pantoprazole Clearance in Children Using a Population Pharmacokinetic Approach.Journal of clinical pharmacology · 2024Article
- Physiologically-based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population.CPT: pharmacometrics & systems pharmacology · 2024Article
- Influence of novel CYP2C-haplotype on proton pump inhibitor pharmacokinetics in children.Clinical and translational science · 2024Article
- Effects of obesity on the pharmacology of proton pump inhibitors: current understanding and future implications for patient care and research.Expert opinion on drug metabolism & toxicology · 2023Review
- Phonomyography on Perioperative Neuromuscular Monitoring: An Overview.Sensors (Basel, Switzerland) · 2022Review
- Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children.Clinical and translational science · 2021Article
- Drug dosing in the critically ill obese patient: a focus on medications for hemodynamic support and prophylaxis.Critical care (London, England) · 2021Review
- Pharmacokinetics of Pantoprazole and Pantoprazole Sulfone in Goats After Intravenous Administration: A Preliminary Report.Frontiers in veterinary science · 2021Article
- Gene-Based Dose Optimization in Children.Annual review of pharmacology and toxicology · 2020Review
- Computational Approaches in Preclinical Studies on Drug Discovery and Development.Frontiers in chemistry · 2020Review
- Article
- Drug Dose Selection in Pediatric Obesity: Available Information for the Most Commonly Prescribed Drugs to Children.Paediatric drugs · 2019Review
- How to Conduct Clinical Trials in Children: A Tutorial.Clinical and translational science · 2019Article
- Considerations for Implementing Precision Therapeutics for Children.Clinical and translational science · 2019Article
- Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity.Pharmaceutical regulatory affairs : open access · 2019Article
- A Population-Based Pharmacokinetic Model Approach to Pantoprazole Dosing for Obese Children and Adolescents.Paediatric drugs · 2018Article
- Reply.The Journal of pediatrics · 2018Article
Corrections and comments
- Commented on byReply.2018
- Commented on by
Authors and funding
10 authors at 6 institutions in 1 country.
Funding
Abstract
objectiveTo assess appropriate pantoprazole dosing for obese children, we conducted a prospective pharmacokinetics (PK) investigation of pantoprazole in obese children, a patient population that is traditionally excluded from clinical trials. STUDY
designA total of 41 obese children (6-17 years of age), genotyped for CYP2C19 variants *2, *3, *4, and *17, received a single oral dose of pantoprazole, ~1.2 mg/kg lean body weight (LBW), with LBW calculated via a validated formula. Ten post-dose pantoprazole plasma concentrations were measured, and PK variables generated via noncompartmental methods (WinNonlin). Linear and nonlinear regression analyses and analyses of variance were used to explore obesity, age, and CYP2C19 genotype contribution to pantoprazole PK. PK variables of interest were compared with historic nonobese peers treated with pantoprazole.
resultsIndependent of genotype, when normalized to dose per kg total body weight, pantoprazole apparent clearance and apparent volume of distribution were significantly lower (P < .05) and systemic exposure significantly higher (P < .01) in obese vs nonobese children. When normalized per kg LBW, these differences were not evident in children ≥12 years of age and markedly reduced in children <12 years of age.
conclusionsLBW dosing of pantoprazole led to pantoprazole PK similar to nonobese peers. Additional factors, other than body size (eg, age-related changes in CYP2C19 activity), appear to affect pantoprazole PK in children <12 years of age.
trial registrationClinicalTrials.gov: NCT02186652.
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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.