title: Healing of Erosive Esophagitis and Improvement of Symptoms of Gastroesophageal Reflux Disease After Esomeprazole Treatment in Children 12 to 36 Months Old.
abstract: OBJECTIVE
  The aim of the study was to evaluate erosive esophagitis healing and symptom improvement with once-daily esomeprazole in children ages 12 to 36 months with endoscopically or histologically proven gastroesophageal reflux disease (GERD).
  
  
  METHODS
  Data from children ages 12 to 36 months were included in a post-hoc analysis of an 8-week, multicenter, randomized, and double-blind by dose strata study of patients ages 1 to 11 years with endoscopically or histologically confirmed GERD. Children were randomized to receive esomeprazole 5 or 10 mg once daily. Patients underwent endoscopy and, if required, mucosal biopsy at baseline. Patients who had erosive esophagitis (graded using the Los Angeles classification system) at baseline underwent a follow-up endoscopy at final study visit to assess healing of erosive esophagitis. Investigators scored severity of GERD symptoms at baseline and every 2 weeks using the Physician Global Assessment.
  
  
  RESULTS
  Thirty-one of 109 primary study patients ages 12 to 36 months were included in the post hoc analysis. At baseline, 15 patients (48.4%) had erosive esophagitis, underwent follow-up endoscopy, and were healed after 8 weeks of esomeprazole treatment. Of the 19 patients with moderate-to-severe baseline Physician Global Assessment symptom scores, 84.2% had lower scores by the final visit. Following esomeprazole treatment, GERD symptoms were significantly improved from baseline to final visit (P ≤ 0.0018).
  
  
  CONCLUSIONS
  Esomeprazole 5 or 10 mg may be used to successfully treat erosive esophagitis and symptoms of GERD in children as young as 1 year.Moreover, although not yet validated in pediatric patients, the Los Angeles classification system was useful in grading erosive esophagitis in children ages 12 to 36 months.
authors.affiliation: *Providence Hospital, Southfield, MI †Baylor College of Medicine, Houston, TX ‡AstraZeneca LP, Wilmington, DE.
authors.forename: Vasundkara
authors.initials: V
authors.lastname: Tolia
authors.forename: Mark A
authors.initials: MA
authors.lastname: Gilger
authors.forename: Peter N
authors.initials: PN
authors.lastname: Barker
authors.forename: Marta
authors.initials: M
authors.lastname: Illueca
mesh_terms: D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D002675:Child, Preschool; D004311:Double-Blind Method; D064098:Esomeprazole / Q000627:therapeutic use*; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008297:Male; D010372:Pediatrics; D010437:Peptic Ulcer / Q000188:drug therapy* / Q000209:etiology; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D064098:Esomeprazole