Document Detail

Famotidine for infant gastro-oesophageal reflux: a multi-centre, randomized, placebo-controlled, withdrawal trial.
MedLine Citation:
PMID:  12752346     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Gastro-oesophageal reflux afflicts up to 7% of all infants. Histamine-2 receptor antagonists are the most commonly prescribed medications for this disorder, but few controlled studies support this practice. AIM: To evaluate the safety and efficacy of famotidine for infant gastro-oesophageal reflux disease. METHODS: Thirty-five infants, 1.3-10.5 months of age, entered an 8-week, multi-centre, randomized, placebo-controlled, two-phase trial: first 4 weeks, observer-blind comparison of famotidine 0.5 mg/kg and famotidine 1.0 mg/kg; second 4 weeks, double-blind withdrawal comparison (safety and efficacy) of each dose with placebo. RESULTS: No serious adverse events were reported. Eleven patients had 16 non-serious, possibly drug-related adverse experiences: 6 patients with agitation or irritability (manifested as head-rubbing in two), 3 patients with somnolence, 2 patients with anorexia, 2 with headache, 1 patient with vomiting, 1 patient with hiccups, and 1 patient with candidiasis. Of the 35 infants, 27 completed Part I. There were significant score improvements for famotidine 0.5 mg/kg in regurgitation frequency (P = 0.04), and for famotidine 1.0 mg/kg in crying time (P = 0.027) and regurgitation frequency (P = 0.004) and volume (P = 0.01). Eight infants completed Part II on double-blind treatment, which was insufficient for meaningful comparisons. CONCLUSIONS: Histamine-2 receptor antagonists may cause agitation and headache in infants. A possibly efficacious famotidine dose for infants is 0.5 mg/kg (frequency adjusted for age). As 1.0 mg/kg may be more efficacious in some, the dosage may require individualization based on response. Further sizeable placebo-controlled evaluations of histamine-2 receptor antagonists in infants with gastro-oesophageal reflux disease are warranted.
S R Orenstein; T M Shalaby; S N Devandry; C A Liacouras; S J Czinn; J E Dice; T J Simon; S P Ahrens; L A Stauffer
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  17     ISSN:  0269-2813     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  2003 May 
Date Detail:
Created Date:  2003-05-19     Completed Date:  2003-06-23     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  1097-107     Citation Subset:  IM    
Pediatric Gastroenterology, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh, PA 15213-2583, USA.
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MeSH Terms
Administration, Oral
Famotidine / administration & dosage*,  adverse effects
Gastroesophageal Reflux / drug therapy*
Histamine H2 Antagonists / administration & dosage*,  adverse effects
Infant, Newborn
Treatment Outcome
Reg. No./Substance:
0/Histamine H2 Antagonists; 76824-35-6/Famotidine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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