Maintenance therapy of duodenal ulcer with famotidine. A multicenter United States study.

The decision to treat a patient with duodenal ulcer should be based upon the following: severity of disease; effectiveness of treatment; and risk and cost of treatment. A number of drugs are effective for this condition. When administration of the drug is discontinued, a recurrence of the ulcer occurs most often within three months, with the rate approaching 90 percent at one year. Maintenance therapy has evolved as a method of preventing recurrence. A double-blind, randomized, multicenter study was done to compare 40 mg of famotidine at bedtime, 20 mg of famotidine at bedtime, and placebo in the maintenance treatment of patients with recently healed duodenal ulcer. In 37 centers in the United States, 303 patients received randomly allocated treatment with 40 mg of famotidine at bedtime (107 patients), 20 mg of famotidine at bedtime (97 patients), or placebo (99 patients). The treatment groups were comparable as to the risk factors and other characteristics. Esophagogastroduodenoscopies were scheduled at three, six, and 12 months of treatment. Additional endoscopies could be done at any time if symptoms suggested a relapse. Cumulative relapse rates were significantly lower in the famotidine groups than in the placebo group at all time points (p less than 0.01). The cumulative life-table relapse rates at three, six, and 12 months were 9.2, 20.9, and 24.8 percent for the 40-mg famotidine group; 13.5, 16.1, and 23.3 percent for the 20-mg famotidine group; and 39.3, 51.5, and 56.8 percent for the placebo group. No significant difference between the two famotidine groups was observed. Within each period, the relapse rate was lower with famotidine than with placebo. Famotidine is more effective than placebo as maintenance therapy. It is generally well tolerated for periods of up to one year. A dose of 20 mg at bedtime is proposed as the maintenance dose. Fewer relapses occurred in non-smokers, in females, and in patients in whom healing occurred with placebo. More relapses occurred in patients under 40 years of age, patients with a long ulcer history, or patients who were younger than 40 years of age at onset of ulcer disease.