Peer-reviewed article
The pharmacokinetics and safety of vonoprazan in adolescents and children with gastroesophageal reflux disease
Darcy J. Mulford, David A. Gremse, Yu‐Ming Chang, Eckhard Leifke, Thomas Wagner et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study evaluated how the drug vonoprazan is processed in the body and its safety in children and adolescents (ages 6-17) with gastroesophageal reflux disease (GERD). Forty-two children received either 10 mg or 20 mg of vonoprazan daily for 14 days. The drug was absorbed and processed similarly to how it works in adults, and children reported improvement in reflux symptoms with minimal side effects.
Key points
- Drug exposure levels in children (6-17 years) were nearly identical to adult exposure levels
- Children reported improvement in GERD symptoms at both tested doses
- Six treatment-emergent adverse events occurred, with only one related to the study drug and none serious
- No subjects discontinued treatment due to adverse events
- The 10 mg and 20 mg doses appear appropriate for pediatric use based on pharmacokinetic findings
Limitations
This is a short 14-day study with a small sample size (42 subjects) and no comparison group, so it cannot establish long-term safety or effectiveness compared to other treatments for GERD in children. The study does not provide detailed information about the characteristics of symptoms before and after treatment.
Abstract
Abstract Objectives Vonoprazan, a potassium‐competitive acid blocker, provides more rapid, potent, and durable elevations in gastric pH than proton pump inhibitors in adults and may be a treatment option for adolescents and children with gastroesophageal reflux disease (GERD). The pharmacokinetics and safety of vonoprazan in pediatric subjects (6–17 years) with symptomatic GERD were evaluated in two clinical studies. Methods Forty‐two subjects were randomized to vonoprazan 10 or 20 mg once daily for 14 days. Plasma vonoprazan concentrations were analyzed employing a two‐compartment population pharmacokinetic model developed using adult data. Individual estimates of maximum concentration at steady state (C max,SS ) and area under the drug concentration‐time curve during the dosing interval τ at steady state (AUC τ,SS ) were calculated. Individual apparent oral clearance (CL/F) and central volume of distribution (V c /F) were calculated from the model‐based estimates. The effect on GERD symptoms and their severity was qualitatively assessed. Results Model‐based analyses showed that exposures (AUC τ,ss ) of vonoprazan in pediatric subjects (6–17 years) were nearly identical to adult exposures. Model‐based exposure estimates from pediatric subjects were also nearly identical to noncompartmental exposure estimates from adults in other studies for both vonoprazan doses. Subjects reported improvement in GERD symptoms, regardless of vonoprazan dosage. There were six treatment‐emergent adverse events, one of which was related to the study drug; none were serious, nor resulted in treatment discontinuation. Conclusions Exposures of vonoprazan in adolescents and children were nearly identical to exposures observed in adults, confirming the appropriateness of vonoprazan 10 and 20 mg doses in a pediatric population.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Vonoprazan 10 mg or 20 mg once daily for 14 days
- Population
- 42 children and adolescents aged 6-17 years with symptomatic GERD
Key finding
Drug exposure (AUC) in pediatric subjects was nearly identical to adult exposures at both 10 mg and 20 mg doses