Skip Navigation LinksHome > December 2013 - Volume 57 - Issue 6 > Efficacy and Safety of Rabeprazole in Children (1–11 Years)...
Journal of Pediatric Gastroenterology & Nutrition:
doi: 10.1097/MPG.0b013e3182a4e718
Original Articles: Gastroenterology

Efficacy and Safety of Rabeprazole in Children (1–11 Years) With Gastroesophageal Reflux Disease

Haddad, Ibrahim*; Kierkus, Jaroslaw; Tron, Eduardo; Ulmer, April§; Hu, Peter||; Sloan, Sheldon||; Silber, Steven||; Leitz, Gerhard||

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Abstract

Objective: Evaluate the efficacy and safety of rabeprazole in children, 1 to 11 years old, with endoscopically/histologically proven gastroesophageal reflux disease (GERD).

Methods: Children were randomized to 0.5- or 1.0-mg/kg rabeprazole granule formulation for 12 weeks. The dose was further determined by weight: children 6 to 14.9 kg (low-weight cohort) received 5 or 10 mg and children ≥15 kg (high-weight cohort) received 10 or 20 mg. The primary endpoint was endoscopic/histologic healing at week 12 (defined as grade 0 on the Hetzel-Dent classification scale and/or grade 0 on the Histological Features of Reflux Esophagitis scale).

Results: Overall, 81% (87/108) achieved endoscopic/histologic healing at week 12 with higher healing in the low-weight cohort (82% [5-mg dose], 94% [10-mg dose]) compared with high-weight cohort (76% [10-mg dose], 78% [20-mg dose]). There was a significant (P < 0.001) decrease in the mean Total GERD Symptoms and Severity score from 19.7 points (baseline) to 8.6 points (week 12), with 26% fewer children reporting GERD symptoms at week 12. The average frequency of symptoms per child decreased from 7.7 (week 1) to 4.7 (week 12). The GERD Symptom Relief score showed that 71% of children felt better, 81% were rated “good to excellent” on the Global Treatment Satisfaction scale by the investigator; 77% were rated “good to excellent” on the Clinical Global Impressions-Improvement scale by the parent/caregiver. The most common (>10%) treatment-emergent adverse events included cough and vomiting (14% each), abdominal pain (12%), and diarrhea (11%).

Conclusions: Rabeprazole was effective and safe in 1- to 11-year-old children with GERD.

© 2013 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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