Famotidine for infant gastro-oesophageal reflux: a multi-centre, randomized, placebo-controlled, withdrawal trial.

Abstract

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.

• Authors: 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
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 17 Issue 9 Pg. 1097-107 (May 01 2003) ISSN: 0269-2813 [Print] England
• PMID: 12752346 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Histamine H2 Antagonists
• Famotidine

Topics

• Administration, Oral
• Famotidine (administration & dosage, adverse effects)
• Female
• Gastroesophageal Reflux (drug therapy)
• Histamine H2 Antagonists (administration & dosage, adverse effects)
• Humans
• Infant
• Infant, Newborn
• Male
• Treatment Outcome