Abstract | OBJECTIVE: 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.
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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)
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Chemical References |
- Proton Pump Inhibitors
- Rabeprazole
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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)
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