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
Received 2 June 2008; received in revised form 28 July 2008; accepted 30 September 2008. published online 04 December 2008.
Refers to article:
Stop the PPI Express: They Don't Keep Babies Quiet!
Philip E. Putnam
The Journal of Pediatrics
April 2009 (Vol. 154, Issue 4, Pages 475-476) Full Text |
Full-Text PDF (127 KB)
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.
aFrom the University of Pittsburgh School of Medicine, Pittsburgh, PA
bDivision of Gastroenterology, BC Children's Hospital/University of British Columbia, Vancouver, BC, Canada
cDepartment of Neonate and Infant Pathology and Cardiology, Medical University of Lublin, Lublin, Poland
dTakeda Global Research & Development Center, Inc, Deerfield, IL
Correspondence to: Susan R. Orenstein, MD, 303 Church Lane, Pittsburgh, PA 15238
Takeda Global Research & Development Center, Inc sponsored the clinical trial (ClinicalTrials.govNCT00324974) and data analysis (TAP Pharmaceutical Products, Inc is now part of Takeda Global Research & Development Center, Inc.). The sponsor provided no financial support for the preparation of this article. S.O., E.H., and W.F.-J. have served as consultants to Takeda Global Research & Development Center, Inc, as well as to other companies making drugs in the same class. S.A. and M.R. are employed by Takeda Global Research & Development Center, Inc.
ABSTRACT