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|Title:||Pharmacokinetics and acid-suppressive effects of esomeprazole in infants 1-24 months old with symptoms of Gastroesophageal reflux disease|
|Citation:||Journal of Pediatric Gastroenterology and Nutrition, 2007; 45(5):530-537|
|Publisher:||Lippincott Williams & Wilkins|
|Taher Omari, Geoffrey Davidson, Patrik Bondarov, Emma Naucler, Catarina Nilsson and Per Lundborg|
|Abstract:||<h4>Objectives</h4>To evaluate the pharmacokinetics and acid-suppressive effects of esomeprazole in infants with gastroesophageal reflux disease (GERD).<h4>Patients and methods</h4>In this single-blind, randomized, parallel-group study, 50 infants 1 to 24 months old with symptoms of GERD, and >or=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.<h4>Results</h4>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 micromol x h/L for the 0.25 mg/kg and 1 mg/kg dosages of esomeprazole, respectively. Both esomeprazole dosages were well tolerated.<h4>Conclusions</h4>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.|
|Keywords:||Humans; Gastroesophageal Reflux; Anti-Ulcer Agents; Treatment Outcome; Administration, Oral; Severity of Illness Index; Area Under Curve; Single-Blind Method; Dose-Response Relationship, Drug; Hydrogen-Ion Concentration; Time Factors; Child, Preschool; Infant; Infant, Newborn; Australia; Esomeprazole|
|Rights:||© 2007 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition|
|Appears in Collections:||Paediatrics publications|
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