MONTREAL — Pantoprazole safely reduces gastroesophageal reflux symptoms in children and adolescents at roughly half the adult dosage, according to two studies funded by Wyeth Pharmaceuticals, which manufactures the proton pump inhibitor.
The company does not yet have pediatric approval for the drug (Protonix), but the study fills “an unmet need for appropriate dosing information across the spectrum of pediatric patients,” said Elaine Soffer, director of clinical research and development for the company, which is based in Collegeville, Pa.
The studies, presented as posters at the 13th World Congress of Gastroenterology, compared once-daily treatment at 10, 20, or 40 mg in 53 children aged 5–11 years, and once-daily treatment at 20 or 40 mg in 136 adolescents aged 12–16 years.
The younger age group had endoscopically proven gastroesophageal reflux disease (GERD), while the older age group had a clinical diagnosis of GERD. All patients were randomized into one of the treatment groups for 8 weeks.
The GERD Assessment of Symptoms in Pediatrics Questionnaire (GASP-Q) was used at baseline and then weekly to measure the frequency and severity of abdominal pain, chest pain or heartburn, difficulty swallowing, nausea, vomiting or regurgitation, choking when eating, belching, and pain after eating.
After 1 week of treatment, there was a significant improvement in the mean symptom score for children in the 20-mg and 40-mg treatment groups, but this change was not seen until week 3 in the 10-mg treatment group. The difference between the 10-mg and 40-mg groups after 1 week was statistically significant (25 vs. 87 mean change in score from baseline); but scores improved significantly from baseline in all groups by week 8.
In the adolescents, the 40-mg dose was significantly more effective at week 1 and week 6 than was the 20-mg dose, but by week 8, a significant improvement in symptoms was evident in both groups, as measured by the Physicians Global Assessment and the GASP-Q scores.
Teens in the 40-mg group, but not the 20-mg group, significantly decreased their antacid use in the last week of the study, compared with the first week (1.3 tablets vs. 3.2 tablets per week).
Safety was comparable in both teen treatment groups, although there were more early exits and significantly more diarrhea in the high-dose group.
Among the children, one withdrew in the low-dose group because of lack of efficacy. No significant adverse events occurred in any of the treatment groups, and no patients dropped out because of adverse events.
“What these studies demonstrate is that at 8 weeks, there is a significant reduction in symptoms at all doses, and that even at 1 week, you can see a dose effect at the higher dose,” Ms. Soffer said in an interview. Treatment also resulted in healing of erosive esophagitis in all four patients with this diagnosis, she added.
“In children, one might want to be conservative and select the middle dose because it shows an effect at 1 week. … Then if the child doesn't respond fast enough, the higher dose is available,” Ms. Soffer said.