[Comparative efficacy of famotidine and ranitidine in the treatment of acute-phase duodenal ulcer. A French comparative therapeutic trial].

Abstract This multicentric, double-blind and prospective study, which involved 41 French Gastroenterology Units, was designed to evaluate the efficacy and safety of famotidine, 40 mg at bedtime, compared to single dose ranitidine, 300 mg, in promoting the healing of duodenal ulcer. Two hundred and ninety-six patients with endoscopically proven duodenal ulcer were randomly allocated to 2 treatment groups: 148 were treated with famotidine, and 148 with ranitidine. Patients were treated during 4 weeks and then controlled by endoscopy. Unhealed patients at 4 weeks were treated again by the same drug for 2 weeks and then endoscopically controlled. One hundred and nine patients were evaluable in the famotidine group and 111 in the ranitidine group. Groups were well-matched for age, sex, alcohol and smoking habits, and duration of ulcer disease. At 4 weeks of treatment, 86 of the 109 patients treated with famotidine had healed (79 percent) and 74 of the 111 patients treated with ranitidine healed (67 percent). At 6 weeks of treatment, 104 patients had healed in the famotidine group (95 percent) and 101 in the ranitidine group (91 percent). Results were significantly different between the 2 groups at 4 weeks of treatment only (p = 0.039). Among smoking patients, no statistical difference was observed between the 2 groups at 4 and 6 weeks of treatment. By contrast, in non smoking patients, famotidine appeared more effective (83 percent healed) than ranitidine (67 percent) (p = 0.014) at 4 weeks. Both treatments were well tolerated and severe adverse effects were scarcely observed.(ABSTRACT TRUNCATED AT 250 WORDS)