Review of an extensive worldwide study of a new H2-receptor antagonist, famotidine, as compared to ranitidine in the treatment of acute duodenal ulcer.

The efficacy and safety of famotidine, a new potent H2-receptor antagonist, has been studied in 1,031 patients by 68 investigators in 19 countries in a worldwide dose-ranging multicenter comparative study. Three doses of famotidine (40 mg h.s., 20 mg b.i.d., 40 mg b.i.d.) were compared to ranitidine 150 mg b.i.d. There were no significant differences between the groups in baseline characteristics, including duodenal ulcer size. Efficacy parameters included daytime and nocturnal symptom relief and duodenal ulcer healing, documented by endoscopy, and defined as complete re-epithelialization of the ulcer crater. Significant reductions from baseline for day and night pain, beginning during the first 24 h period, were found in all four treatment groups (p less than 0.01). There was little difference among the four treatment groups with respect to the percentage of patients healed after 4 and 8 weeks of treatment. Healing rates for the three famotidine groups (40 mg h.s., 20 mg b.i.d., 40 mg b.i.d.) were 88, 92 and 92%, respectively, after 8 weeks of treatment as compared to 91% for the ranitidine group. The occurrence and type of adverse clinical experiences reported was similar for each of the four treatment groups. The most common adverse experiences were headache and diarrhea. The results of this study demonstrate that an h.s. dose of famotidine is equivalent to both b.i.d. famotidine and b.i.d. ranitidine in duodenal ulcer healing and pain relief. In view of possible increased patient compliance with a simplified dosage regimen, famotidine 40 mg h.s. is recommended in the acute treatment of duodenal ulcer.