Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial Assessing the Efficacy and Safety of Proton Pump Inhibitor Lansoprazole in Infants with Symptoms of Gastroesophageal Reflux Disease

Published:December 04, 2008DOI:https://doi.org/10.1016/j.jpeds.2008.09.054

      Objective

      To assess the efficacy and safety of lansoprazole in treating infants with symptoms attributed to gastroesophageal reflux disease (GERD) that have persisted despite a ≥ 1-week course of nonpharmacologic management.

      Study design

      This multicenter, double-blind, parallel-group study randomized infants with persisting symptoms attributed to GERD to treatment with lansoprazole or placebo for 4 weeks. Symptoms were tracked through daily diaries and weekly visits. Efficacy was defined primarily by a ≥ 50% reduction in measures of feeding-related crying and secondarily by changes in other symptoms and global assessments. Safety was assessed based on the occurrence of adverse events (AEs) and clinical/laboratory data.

      Results

      Of the 216 infants screened, 162 met the inclusion/exclusion criteria and were randomized. Of those, 44/81 infants (54%) in each group were responders—identical for lansoprazole and placebo. No significant lansoprazole–placebo differences were detected in any secondary measures or analyses of efficacy. During double-blind treatment, 62% of lansoprazole-treated subjects experienced 1 or more treatment-emergent AEs, versus 46% of placebo recipients ( P = .058). Serious AEs (SAEs), particularly lower respiratory tract infections, occurred in 12 infants, significantly more frequently in the lansoprazole group compared with the placebo group (10 vs 2; P = .032).

      Conclusions

      This study detected no difference in efficacy between lansoprazole and placebo for symptoms attributed to GERD in infants age 1 to 12 months. SAEs, particularly lower respiratory tract infections, occurred more frequently with lansoprazole than with placebo.

      Abbreviations:

      AE ( Adverse event), GA ( Global assessment), GERD ( Gastroesophageal reflux disease), H2RA ( Histamine-2 receptor antagonist), I-GERQ ( Infant Gastroesophageal Reflux Questionnaire), I-GERQ-MH ( Infant Gastroesophageal Reflux Questionnaire-Medical History), NPM ( Nonpharmacologic management), PPI ( Proton pump inhibitor), SAE ( Serious adverse event)
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