A multicenter, randomized, double-blind study comparing famotidine with ranitidine in the treatment of active duodenal ulcer disease.

Famotidine, a new long-acting histamine (H2)-receptor antagonist, has recently been shown to be more effective than placebo in healing active duodenal ulcer. In the current study, the efficacy and tolerability of famotidine were further investigated and compared with those of ranitidine in a multicenter, double-blind, randomized international study. Sixty-eight investigators from 19 countries enrolled 1,031 patients with endoscopically proven active duodenal ulcers. Patients received either ranitidine (150 mg twice daily) or famotidine at one of three different dosage regimens: 40 mg at bedtime, 40 mg twice daily, or 20 mg twice daily. Ulcer healing was assessed by serial endoscopy with pain relief and safety profiles also closely monitored. Nine hundred and eighty patients fulfilled the evaluation criteria. During the eight-week study, there was no significant difference in ulcer healing rates between the ranitidine control group and any of the famotidine treatment groups. At eight weeks, the healing rates were 87, 92, 92, and 90 percent for the famotidine (40 mg at bedtime, 20 mg twice daily, and 40 mg twice daily) and ranitidine groups, respectively. Ulcer pain improved and antacid consumption decreased in all the groups equally. The clinical and safety profiles were also similar in all four groups. This study indicates that famotidine used once or twice a day is as effective and well tolerated as twice-a-day ranitidine in the treatment of active duodenal ulcers, with the recommended dosage being 40 mg at bedtime. Furthermore, these data emphasize the importance of nocturnal acid secretion in the pathophysiology of duodenal ulcer disease.