Studying the pharmacokinetics of pantoprazole, a stomach acid-suppressing medication often used to manage gastroesophageal reflux disease (GERD), in obese children and adolescents.

Summary

The World Health Organization has called childhood obesity one of the most serious public health challenges of the 21st century. The alarming childhood obesity epidemic brings with it increasing need for pediatricians to treat obesity-related diseases that traditionally have not had origins in childhood or adolescence, leading to a critical therapeutic information gap in pediatrics. Given that obese participants are often excluded from clinical trials during the drug development process, little to no information exists regarding the impact of obesity on drug disposition and action or the appropriate dosing of drugs in obese pediatric patients.

Obese children are more frequently diagnosed with gastroesophageal reflux disease (GERD) than children of normal weight. Proton pump inhibitors, such as pantoprazole, have become key components in the pharmacological management of GERD in pediatrics. In this multicenter, open-label, single-dose study of pantoprazole, the PTN examined the pharmacokinetics of the drug in obese children who required treatment with an acid-modifying agent. The data collected in this study were compared to existing pharmacokinetic data in non-obese subjects.

The study population comprised obese male and female children and adolescents, ranging in age from 6–17 years (inclusive) with the diagnosis of GERD. Approximately 40 participants were enrolled at four U.S. sites.

Results

The study found that the PK of pantoprazole in children is affected by obesity, with higher exposures and slower drug clearance observed in obese children and adolescents relative to their nonobese, age-matched peers. Dosing based on lean body weight led to pantoprazole PK similar to nonobese peers.

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