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Famotidine for infant gastro‐oesophageal reflux: a multi‐centre, randomized, placebo‐controlled, withdrawal trial
Author(s) -
Orenstein S. R.,
Shalaby T. M.,
Devandry S. N.,
Liacouras C. A.,
Czinn S. J.,
Dice J. E.,
Simon T. J.,
Ahrens S. P.,
Stauffer L. A.
Publication year - 2003
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2003.01559.x
Subject(s) - famotidine , medicine , reflux , placebo , gastro , randomized controlled trial , esophageal disease , gastroenterology , esophagus , alternative medicine , disease , pathology
Summary 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.