Document Detail


Safety and Efficacy of Delayed Release Rabeprazole in 1 to 11 Month-Old Infants with Symptomatic Gastroesophageal Reflux Disease: A Double-Blind, Randomized, Placebo-Controlled, Withdrawal Study.
MedLine Citation:
PMID:  24121146     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
METHODS:: Infants aged 1-11 months, with symptomatic GERD resistant to conservative therapy and/or previous exposure to acid suppressive medications, were screened. After scoring >16 on a GERD symptom score (I-GERQ-R), 344 infants were enrolled in a 1-3 week open-label phase (OL) and received rabeprazole 10-mg/day. Following caregiver-rated clinical improvement during OL, patients were randomized to placebo, rabeprazole 5-mg, or rabeprazole 10-mg in the ensuing 5-week double-blind withdrawal phase (DB). Primary endpoints evaluated from DB baseline to end of DB included frequency of regurgitation, weight-for-age Z-score, and daily and weekly GERD symptom scores.
RESULTS:: Overall, 231 (86%) of the 268 randomized infants (placebo: 90; rabeprazole 5-mg: 90; rabeprazole 10-mg: 88) completed the study. Efficacy endpoints were similarly improved during OL in all groups, and continued improving during DB with no difference between the placebo and combined rabeprazole groups. Mean decrease in frequency of regurgitation (-0.79 vs. -1.20 times/day; p = 0.168); in I-GERQ-R scores (-3.6 [-25%] vs. -3.9 points [-27%]; p = 0.960); in I-GERQ-Daily Diary scores (-1.87 [-19%] vs. -1.85 [-19%]; p = 0.968); and increase in weight-for-age Z-scores (Mean[SD]: 0.11[0.329] vs. 0.14[0.295]; p = 0.440) indicated equal improvement. Equal percentages (47%) reported adverse events in placebo and combined rabeprazole groups, with no new safety signals emerging.
CONCLUSION:: In those infants with GERD who improved with rabeprazole during OL, improvements in symptoms and weight were similar in both those who continued rabeprazole and those withdrawn to placebo during a 5-week DB phase.
Authors:
Sunny Hussain; Jaroslaw Kierkus; Peter Hu; Diane Hoffman; Ray Lekich; Sheldon Sloan; William Treem
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-10-9
Journal Detail:
Title:  Journal of pediatric gastroenterology and nutrition     Volume:  -     ISSN:  1536-4801     ISO Abbreviation:  J. Pediatr. Gastroenterol. Nutr.     Publication Date:  2013 Oct 
Date Detail:
Created Date:  2013-10-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8211545     Medline TA:  J Pediatr Gastroenterol Nutr     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
*WK Pediatric Gastroenterology & Research, Shreveport, Louisiana †Instytut "Pomnik-Centrum Zdrowia Dziecka", Poland ‡Janssen Research & Development, LLC, Raritan, NJ, USA.
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