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.
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.
Obese Children Require Lower Doses of Pantoprazole than Nonobese Peers to Achieve Equal Systematic Drug Exposures. Shakhnovich V, Smith PB, Guptill J, James L, Collier D, Wu H, Livingston C, Zhao J, Kearns G; Best Pharmaceuticals for Children Act – Pediatric Trials Network.
The Journal of Pediatrics • February 2018, volume 193, pages 102-108.
Completed; clinical study report submitted to FDA
P. Brian Smith, MD, MPH, MHS
Duke Health, Durham, NC
Valentina Shakhnovich, MD
Children’s Mercy Hospital
Kansas City, MO
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- PTN Pantoprazole Study Closes Enrollment September 22, 2015 Congratulations to the PTN Pantoprazole Study Team for closing enrollment with 41 subjects. The study goal was to enroll 40 subjects in two age groups. The dedicated team worked hard to keep the study on track and accomplish this goal. The Pantoprazole Study will evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux ...
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