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https://hdl.handle.net/2440/44380
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dc.contributor.author | Omari, T. | - |
dc.contributor.author | Davidson, G. | - |
dc.contributor.author | Bondarov, P. | - |
dc.contributor.author | Naucler, E. | - |
dc.contributor.author | Nilsson, C. | - |
dc.contributor.author | Lundborg, P. | - |
dc.date.issued | 2007 | - |
dc.identifier.citation | Journal of Pediatric Gastroenterology and Nutrition, 2007; 45(5):530-537 | - |
dc.identifier.issn | 0277-2116 | - |
dc.identifier.issn | 1536-4801 | - |
dc.identifier.uri | http://hdl.handle.net/2440/44380 | - |
dc.description.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. | - |
dc.description.statementofresponsibility | Taher Omari, Geoffrey Davidson, Patrik Bondarov, Emma Naucler, Catarina Nilsson and Per Lundborg | - |
dc.language.iso | en | - |
dc.publisher | Lippincott Williams & Wilkins | - |
dc.rights | © 2007 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition | - |
dc.source.uri | http://journals.lww.com/jpgn/pages/articleviewer.aspx?year=2007&issue=11000&article=00003&type=abstract | - |
dc.subject | Humans | - |
dc.subject | Gastroesophageal Reflux | - |
dc.subject | Anti-Ulcer Agents | - |
dc.subject | Treatment Outcome | - |
dc.subject | Administration, Oral | - |
dc.subject | Severity of Illness Index | - |
dc.subject | Area Under Curve | - |
dc.subject | Single-Blind Method | - |
dc.subject | Dose-Response Relationship, Drug | - |
dc.subject | Hydrogen-Ion Concentration | - |
dc.subject | Time Factors | - |
dc.subject | Child, Preschool | - |
dc.subject | Infant | - |
dc.subject | Infant, Newborn | - |
dc.subject | Australia | - |
dc.subject | Esomeprazole | - |
dc.title | Pharmacokinetics and acid-suppressive effects of esomeprazole in infants 1-24 months old with symptoms of Gastroesophageal reflux disease | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1097/MPG.0b013e31812e012f | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Omari, T. [0000-0001-5108-7378] | - |
Appears in Collections: | Aurora harvest 6 Paediatrics publications |
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