title: Pharmacokinetics and Acid-suppressive Effects of Esomeprazole in Infants 1-24 Months Old With Symptoms of Gastroesophageal Reflux Disease.
abstract: OBJECTIVE
  To evaluate the pharmacokinetics and acid-suppressive effects of esomeprazole in infants with gastroesophageal reflux disease (GERD).
  
  
  METHODS
  In this single-blind, randomized, parallel-group study, 50 infants 1 to 24 months old with symptoms of GERD, and ≥ 5% of time with intraesophageal pH <4 during 24-hour dual pH monitoring, received oral esomeprazole 0.25 mg/kg (n = 26) or 1 mg/kg (n = 24) once daily for 1 week. Intraesophageal and intragastric pH were recorded at 1 week, and blood samples were taken for pharmacokinetic analysis.
  
  
  RESULTS
  At baseline, mean percentages of time with intragastric pH >4 and intraesophageal pH <4 were 30.5% and 11.6%, respectively, in the esomeprazole 0.25 mg/kg group and 28.6% and 12.5% in the esomeprazole 1 mg/kg group. After 1 week of treatment, times with intragastric pH >4 were 47.9% and 69.3% in the esomeprazole 0.25 mg/kg and 1 mg/kg groups, respectively (P < 0.001 vs baseline), and times with intraesophageal pH <4 were 8.4% (P < 0.05 vs baseline) and 5.5% (P < 0.001 vs. baseline), respectively. The mean number of acid reflux episodes of >5 minutes duration decreased from 6 at baseline to 3 and 2 with esomeprazole 0.25 mg/kg and 1 mg/kg, respectively. The geometric mean AUC0-t of esomeprazole were 0.24 and 1.79 μmol · h/L for the 0.25 mg/kg and 1 mg/kg dosages of esomeprazole, respectively. Both esomeprazole dosages were well tolerated.
  
  
  CONCLUSIONS
  Oral treatment with esomeprazole 0.25 mg/kg and 1 mg/kg was well tolerated and provided dose-related acid suppression, dose-related exposure to esomeprazole, and decreased esophageal acid exposure in infants 1-24 months old with GERD.
authors.affiliation: *Centre for Paediatric and Adolescent Gastroenterology, Women's and Children's Hospital, North Adelaide, and Department of Paediatrics, University of Adelaide, Australia †AstraZeneca R&D, Mölndal, Sweden.
authors.forename: Taher
authors.initials: T
authors.lastname: Omari
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Davidson
authors.forename: Patrik
authors.initials: P
authors.lastname: Bondarov
authors.forename: Emma
authors.initials: E
authors.lastname: Nauclér
authors.forename: Catarina
authors.initials: C
authors.lastname: Nilsson
authors.forename: Per
authors.initials: P
authors.lastname: Lundborg
mesh_terms: D000284:Administration, Oral; D002675:Child, Preschool; D064098:Esomeprazole / Q000493:pharmacokinetics / Q000627:therapeutic use*; D050782:Esophageal pH Monitoring; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007223:Infant; D008297:Male; D010372:Pediatrics; D054328:Proton Pump Inhibitors / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors; D064098:Esomeprazole