Maintenance of efficacy and safety of rabeprazole in children with endoscopically proven GERD.

Abstract

OBJECTIVE:

The aim of the present study was to evaluate 24-week maintenance of efficacy and safety of rabeprazole in children with endoscopically proven gastroesophageal reflux disease (GERD).

METHODS:

Children ages 1 to 11 years who achieved endoscopic/histologic healing (defined as grade 0 of the Hetzel-Dent Classification scale and/or grade 0 of the Histological Features of Reflux Esophagitis scale) in a 12-week treatment phase were continued on the same dose for an additional 24 weeks during the maintenance phase. The dose was determined by weight: children weighing 6 to 14.9 kg (low-weight cohort) received 5 or 10 mg and children weighing ≥ 15 kg (high-weight cohort) received 10 or 20 mg.

RESULTS:

Healing was maintained in 90% of children (100% [low-weight cohort]; 89% [10 mg, high-weight cohort]; 85% [20 mg, high-weight cohort]). The Total GERD Symptom and Severity score continued to improve slightly in all of the children across all dose groups (P = 0.026) during the maintenance phase, except the 10-mg dose group (low-weight cohort), which experienced a slight worsening of 3.6 points. Overall, 71% children felt better on the GERD Symptom Relief score (P < 0.001); 95% of investigators and 92% of parent/caregivers rated "Good to Excellent" on the Global Treatment Satisfaction scale and Clinical Global Impressions Improvement scale, respectively. Overall incidence of treatment-emergent adverse events was 63%; upper respiratory tract infections (13%) and vomiting (11%) were the most commonly reported (>10%).

CONCLUSIONS:

Rabeprazole was effective in maintaining endoscopic/histologic healing during a 24-week maintenance period in children with endoscopically proven GERD. The clinical effect and safety profile were largely similar across dose groups.

• Authors: Ibrahim Haddad, Jaroslaw Kierkus, Eduardo Tron, April Ulmer, Peter Hu, Steven Silber, Sheldon Sloan, Gerhard J Leitz
• Journal: Journal of pediatric gastroenterology and nutrition (J Pediatr Gastroenterol Nutr) Vol. 58 Issue 4 Pg. 510-7 (Apr 2014) ISSN: 1536-4801 [Electronic] United States
• PMID: 24164904 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Proton Pump Inhibitors
• Rabeprazole

Topics

• Abdominal Pain (chemically induced)
• Child
• Child, Preschool
• Diarrhea (chemically induced)
• Double-Blind Method
• Endoscopy, Gastrointestinal
• Female
• Gastroesophageal Reflux (drug therapy, pathology)
• Humans
• Infant
• Maintenance Chemotherapy (adverse effects)
• Male
• Patient Satisfaction
• Proton Pump Inhibitors (adverse effects, therapeutic use)
• Rabeprazole (adverse effects, therapeutic use)
• Respiratory Tract Infections (chemically induced)
• Severity of Illness Index
• Vomiting (chemically induced)