Randomized, placebo-controlled comparison of famotidine 20 mg b.d. or 40 mg b.d. in patients with erosive oesophagitis.
METHODS
This US multicentre, randomized, double-blind, placebo-controlled, parallel group study determined the effects of two twice daily oral famotidine regimens on symptom relief and healing of erosive oesophagitis in patients with gastro-oesophageal reflux disease. Three hundred and eighteen patients were enrolled: 66 received placebo, 125 received famotidine 20 mg b.d., and 127 received famotidine 40 mg b.d. Patients maintained diaries of their symptoms. Endoscopy was performed at weeks 0 and 6, and again at week 12 if healing had not occurred.


RESULTS
Healing at 6 and 12 weeks was (respectively) 48% (P < or = 0.01 vs. placebo) and 69% (P < or = 0.01 vs. placebo) for famotidine 40 mg b.d.; 32% and 54% (P < or = 0.01 vs. placebo) for famotidine 20 mg b.d., and 18% and 29% for placebo. At both 6 and 12 weeks the healing rates of famotidine 40 mg b.d. were significantly greater than placebo and famotidine 20 mg b.d. Compared to placebo, famotidine produced more frequent global symptom improvement and more rapid heartburn relief. There were no significant differences among treatment groups in the incidence of clinical or laboratory adverse events.


CONCLUSIONS
Famotidine 40 mg b.d. was a better regimen than famotidine 20 mg b.d. or placebo. The clinical efficacy paralleled the previously documented effect of the famotidine regimens on decrease of oesophageal acid exposure.
Simon
T J
TJ
Merck Research Laboratories, West Point, PA.
Berenson
M M
MM
Berlin
R G
RG
Snapinn
S
S
Cagliola
A
A
D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D004941:Esophagitis / Q000188:drug therapy* / Q000209:etiology; D015738:Famotidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications*; D006801:Humans; D008297:Male; D008875:Middle Aged
D015738:Famotidine