Document Detail

Esomeprazole for the treatment of GERD in infants ages 1-11 months.
MedLine Citation:
PMID:  22241513     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: Gastroesophageal reflux disease (GERD) is present in pediatric patients when reflux of gastric contents causes troublesome symptoms and/or complications. The present study evaluates the efficacy and safety of esomeprazole in infants ages 1 to 11 months with GERD.
METHODS: In this multicenter randomized, double-blind, placebo-controlled, parallel-group, treatment-withdrawal study, infants received open-label, weight-adjusted doses of esomeprazole (2.5-10 mg) once daily for 2 weeks. Infants with symptom improvement were randomized to esomeprazole (weight-adjusted doses [2.5-10 mg]) or placebo for 4 weeks. The primary endpoint was time to discontinuation owing to symptom worsening based on global assessments by the parent/guardian and physician. Adverse events were recorded.
RESULTS: Of the 98 patients enrolled, 81 (82.7%) experienced symptom improvement determined by physician global assessment (PGA) during open-label esomeprazole treatment; 80 entered the double-blind phase. During this phase, discontinuation rates owing to symptom worsening were 48.8% (20/41) for placebo-treated versus 38.5% (15/39) for esomeprazole-treated patients (hazard ratio 0.69; P = 0.28). Posthoc analysis of infants with symptomatic GERD (ie, no diagnostic procedure performed) revealed that time to discontinuation was significantly longer with esomeprazole than placebo (hazard ratio 0.24; P = 0.01); the complementary subgroup difference was not significant (hazard ratio 1.39; P = 0.48). Esomeprazole was well tolerated.
CONCLUSIONS: The discontinuation rate owing to symptom worsening did not differ significantly between infants receiving esomeprazole versus those receiving placebo. Improved diagnostic criteria in this age group are needed to identify infants with GERD who may benefit from acid suppression therapy.
Harland Winter; Thirumazhisai Gunasekaran; Vasundhara Tolia; Frederic Gottrand; Peter N Barker; Marta Illueca
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of pediatric gastroenterology and nutrition     Volume:  55     ISSN:  1536-4801     ISO Abbreviation:  J. Pediatr. Gastroenterol. Nutr.     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-06-14     Completed Date:  2012-11-19     Revised Date:  2013-01-07    
Medline Journal Info:
Nlm Unique ID:  8211545     Medline TA:  J Pediatr Gastroenterol Nutr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  14-20     Citation Subset:  IM    
MassGeneral Hospital for Children, Boston, MA 02114, USA.
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MeSH Terms
Chi-Square Distribution
Double-Blind Method
Esomeprazole Sodium / adverse effects,  therapeutic use*
Gastroesophageal Reflux / drug therapy*
Kaplan-Meier Estimate
Proportional Hazards Models
Proton Pump Inhibitors / adverse effects,  therapeutic use*
Treatment Outcome
Reg. No./Substance:
0/Proton Pump Inhibitors; L2C9GWQ43H/Esomeprazole Sodium

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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