Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months
Journal of Pediatric Gastroenterology and Nutrition, 06/14/2012
Winter H et al. – 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.Methods
- In this multicenter randomized, double-blind, placebo-controlled, parallel-group, treatment-withdrawal study, infants received open-label, weight-adjusted doses of esomeprazole (2.5–10mg) 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.
- 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.