title: Efficacy and safety of rabeprazole in children (1-11 years) with gastroesophageal reflux disease.
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.
authors.affiliation: *Pediatric & Adolescent Gastroenterology & Nutrition, Youngstown, OH †Children's Memorial Health Institute, Warsaw, Poland ‡Geisinger Medical Center Clinic, Wilkes Barre, PA §Gastrointestinal Associates, Jackson, MS ||Janssen Research & Development, LLC, Titusville, NJ.
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Haddad
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Kierkus
authors.forename: Eduardo
authors.initials: E
authors.lastname: Tron
authors.forename: April
authors.initials: A
authors.lastname: Ulmer
authors.forename: Peter
authors.initials: P
authors.lastname: Hu
authors.forename: Sheldon
authors.initials: S
authors.lastname: Sloan
authors.forename: Steven
authors.initials: S
authors.lastname: Silber
authors.forename: Gerhard
authors.initials: G
authors.lastname: Leitz
mesh_terms: D015746:Abdominal Pain / Q000188:drug therapy / Q000209:etiology; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D003967:Diarrhea / Q000188:drug therapy / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007223:Infant; D008297:Male; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D064750:Rabeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014839:Vomiting / Q000188:drug therapy / Q000209:etiology
chemical_list: D054328:Proton Pump Inhibitors; D064750:Rabeprazole