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: Providence Hospital, Southfield, MI, USA. vasu.tolia@gmail.com
authors: Vasundhara
authors: V
authors: Tolia
authors: Mark A
authors: MA
authors: Gilger
authors: Peter N
authors: PN
authors: Barker
authors: Marta
authors: M
authors: 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* / Q000209:etiology; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008297:Male; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D064098:Esomeprazole