Famotidine in the management of duodenal ulcer: an analysis of multicenter findings worldwide.

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.