Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/80525
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Type: Journal article
Title: Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients
Author: Davidson, G.
Wenzl, T.
Thomson, M.
Omari, T.
Barker, P.
Lundborg, P.
Illueca, M.
Citation: Journal of Pediatrics, 2013; 163(3):692-698
Publisher: Mosby Inc
Issue Date: 2013
ISSN: 0022-3476
1097-6833
Statement of
Responsibility: 
Geoffrey Davidson, Tobias G. Wenzl, Michael Thomson, Taher Omari, Peter Barker, Per Lundborg, and Marta Illueca
Abstract: OBJECTIVE: To evaluate the efficacy and safety of proton pump inhibitors in infants aged <1 year with gastroesophageal reflux disease (GERD). STUDY DESIGN: In this randomized, double-blind, placebo-controlled multicenter study, neonates (premature to 1 month corrected age; n = 52) with signs and symptoms of GERD received esomeprazole 0.5 mg/kg or placebo once daily for up to 14 days. Change from baseline in the total number of GERD symptoms (from video monitoring) and GERD-related signs (from cardiorespiratory monitoring) was assessed with simultaneous esophageal pH, impedance, cardiorespiratory, and 8-hour video monitoring. RESULTS: There were no significant differences between the esomeprazole and placebo groups in the percentage change from baseline in the total number of GERD-related signs and symptoms (-14.7% vs -14.1%, respectively). Mean change from baseline in total number of reflux episodes was not significantly different between esomeprazole and placebo (-7.43 vs -0.2, respectively); however, the percentage of time pH was <4.0 and the number of acidic reflux episodes >5 minutes in duration was significantly decreased with esomeprazole vs placebo (-10.7 vs 2.2 and -5.5 vs 1.0, respectively; P ≤ .0017). The number of patients with adverse events was similar between treatment groups. CONCLUSIONS: Signs and symptoms of GERD traditionally attributed to acidic reflux in neonates were not significantly altered by esomeprazole treatment. Esomeprazole was well tolerated and reduced esophageal acid exposure and the number of acidic reflux events in neonates.
Keywords: Humans; Gastroesophageal Reflux; Infant, Premature, Diseases; Monitoring, Physiologic; Treatment Outcome; Administration, Oral; Drug Administration Schedule; Analysis of Variance; Follow-Up Studies; Double-Blind Method; Infant; Infant, Newborn; Infant, Premature; Female; Male; Proton Pump Inhibitors; Intention to Treat Analysis; Esomeprazole Sodium
Rights: Copyright © 2013 Mosby, Inc. All rights reserved.
RMID: 0020131338
DOI: 10.1016/j.jpeds.2013.05.007
Appears in Collections:Paediatrics publications

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