title: Esomeprazole for the treatment of GERD in infants ages 1-11 months.
abstract: OBJECTIVE
  Gastroesophageal reflux disease (GERD) is present in pediatric patients when reflux of gastric contents causes troublesome symptoms and/or complications. The present study evaluates the efficacy and safety of esomeprazole in infants ages 1 to 11 months with GERD.
  
  
  METHODS
  In this multicenter randomized, double-blind, placebo-controlled, parallel-group, treatment-withdrawal study, infants received open-label, weight-adjusted doses of esomeprazole (2.5-10 mg) once daily for 2 weeks. Infants with symptom improvement were randomized to esomeprazole (weight-adjusted doses [2.5-10 mg]) or placebo for 4 weeks. The primary endpoint was time to discontinuation owing to symptom worsening based on global assessments by the parent/guardian and physician. Adverse events were recorded.
  
  
  RESULTS
  Of the 98 patients enrolled, 81 (82.7%) experienced symptom improvement determined by physician global assessment (PGA) during open-label esomeprazole treatment; 80 entered the double-blind phase. During this phase, discontinuation rates owing to symptom worsening were 48.8% (20/41) for placebo-treated versus 38.5% (15/39) for esomeprazole-treated patients (hazard ratio 0.69; P = 0.28). Posthoc analysis of infants with symptomatic GERD (ie, no diagnostic procedure performed) revealed that time to discontinuation was significantly longer with esomeprazole than placebo (hazard ratio 0.24; P = 0.01); the complementary subgroup difference was not significant (hazard ratio 1.39; P = 0.48). Esomeprazole was well tolerated.
  
  
  CONCLUSIONS
  The discontinuation rate owing to symptom worsening did not differ significantly between infants receiving esomeprazole versus those receiving placebo. Improved diagnostic criteria in this age group are needed to identify infants with GERD who may benefit from acid suppression therapy.
authors.affiliation: MassGeneral Hospital for Children, Boston, MA 02114, USA. hwinter@partners.org
authors.forename: Harland
authors.initials: H
authors.lastname: Winter
authors.forename: Thirumazhisai
authors.initials: T
authors.lastname: Gunasekaran
authors.forename: Vasundhara
authors.initials: V
authors.lastname: Tolia
authors.forename: Frederic
authors.initials: F
authors.lastname: Gottrand
authors.forename: Peter N
authors.initials: PN
authors.lastname: Barker
authors.forename: Marta
authors.initials: M
authors.lastname: Illueca
mesh_terms: D016009:Chi-Square Distribution; D004311:Double-Blind Method; D064098:Esomeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D053208:Kaplan-Meier Estimate; D008297:Male; D016016:Proportional Hazards Models; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors; D064098:Esomeprazole