An integrated analysis of the fifteen published prospective multicenter studies that have examined the safety and efficacy of
famotidine for the short-term (13) and maintenance (2)
therapy of
duodenal ulcer included over 2,600 patients. The thirteen studies of endoscopically proved acute
duodenal ulcer that were published in English or were available in a complete English translation were reviewed. Six of these studies compared
famotidine with
ranitidine, one with
cimetidine, one with
gefarnate, and one with placebo, and four were uncontrolled. In controlled studies of the short-term
therapy of symptomatic
duodenal ulcer,
famotidine was equal in efficacy to
ranitidine or
cimetidine and superior to placebo and
gefarnate at all times examined. The efficacy of
famotidine was examined in three oral dosing regimens--20 mg BID, 40 mg HS, and 40 mg BID. There were no significant differences in efficacy or side effects associated with these three regimens. Overall, the cumulative healing rate with
famotidine was 46% at two weeks, 77% at four weeks, and 91% at eight weeks. In studies involving 50 patients or more,
famotidine 40 mg orally HS resulted in healing rates for active
duodenal ulcer of 82% to 100% after four weeks. Adverse effects were uncommon with all dosages examined. Adverse effects led to the discontinuation of
therapy in three patients--two owing to the development of
rash and one because of
dizziness.
Headache and
constipation were the most common adverse experiences, but in no study were the adverse experiences that were seen with
famotidine significantly more frequent than those seen with
ranitidine or placebo. No patient undergoing
therapy for active
duodenal ulcer had a biochemical abnormality that required a change in
therapy or that was
drug related in the opinion of the investigator. Multicenter studies examining the efficacy of
famotidine in reducing the incidence of
duodenal ulcer recurrence showed that
famotidine was superior to placebo at all intervals examined. In conclusion, the data from the studies included in this review show that
famotidine is highly effective and generally well tolerated both in the short-term treatment of active
duodenal ulcer and in the maintenance
therapy of
duodenal ulcer.