title: 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.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, Raritan, 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: Steven
authors.initials: S
authors.lastname: Silber
authors.forename: Sheldon
authors.initials: S
authors.lastname: Sloan
authors.forename: Gerhard J
authors.initials: GJ
authors.lastname: Leitz
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced; D002648:Child; D002675:Child, Preschool; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000473:pathology*; D006801:Humans; D007223:Infant; D060046:Maintenance Chemotherapy / Q000009:adverse effects; D008297:Male; D017060:Patient Satisfaction; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D064750:Rabeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D012141:Respiratory Tract Infections / Q000139:chemically induced; D012720:Severity of Illness Index; D014839:Vomiting / Q000139:chemically induced
chemical_list: D054328:Proton Pump Inhibitors; D064750:Rabeprazole