Efficacy and Safety of Once-Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease in Neonatal Patients

Geoffrey Davidson, Tobias Wenzl, Michael Thomson, Taher Omari, Peter Barker, Per Lundborg, Marta Illueca

    Research output: Contribution to journalArticle

    43 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)692-698.e2
    Number of pages7
    JournalJournal of Pediatrics
    Volume163
    Issue number3
    DOIs
    Publication statusPublished - Sep 2013

    Keywords

    • AE Adverse event GER Gastroesophageal reflux GERD Gastroesophageal reflux disease LSM Least square mean ITT Intent-to-treat PPI Proton pump inhibitor SAE Serious adverse event

    Fingerprint Dive into the research topics of 'Efficacy and Safety of Once-Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease in Neonatal Patients'. Together they form a unique fingerprint.

    Cite this