Final report on the United States Multicenter Trial comparing ranitidine to cimetidine as maintenance therapy following healing of duodenal ulcer

Patients with recently healed duodenal ulcers were enrolled at 14 participating centers in a 12-month study comparing the effectiveness of ranitidine and cimetidine, two H2-receptor blockers, for maintenance therapy. Patients were randomly assigned to take bedtime doses of 150 mg of ranitidine (n = 60) or 400 mg of cimetidine (n = 66). Endoscopic examinations were scheduled at baseline and after 4, 8, and 12 months of therapy, or when symptoms compatible with active ulcer disease developed. Life-table analysis indicated a relapse rate of 16% for the ranitidine subjects and 43% for the cimetidine subjects during the 12-month period (p = 0.01). Therapy was discontinued in one ranitidine subject and two cimetidine subjects for adverse events considered drug-related. There were no drug-related laboratory abnormalities in either treatment group. No significant drug-related adverse effects were seen with either drug during this 1-year trial. At the doses prescribed, ranitidine was superior to cimetidine as maintenance therapy in duodenal ulcer disease.