Long term cimetidine therapy for the prevention of recurring peptic ulcer: a multicenter study.

The aim of this study was to gain experience regarding the efficacy and safety of cimetidine 400 mg nightly for the long-term maintenance treatment of peptic ulcers three years. The trial was carried out in 44 centres in 12 countries. 1988 patients with endoscopically-proven peptic ulceration initially underwent an acute treatment over 6-12 weeks (open study) with 1000 mg cimetidine-the dosage could be increased to 1600 mg daily if necessary. After 6 weeks, 81% of patients had healed ulcers and the cumulative healing rate after 12 weeks rose to 95%. The statistical analysis of the subsequent long-term maintenance treatment was based on data from 1726 patients (82% with healed pyloric or duodenal ulcers; 16% with ulcus ventriculi and 2% with ulcers subsequent to stomach surgery) who received 400 mg cimetidine nightly over 3 years. Based on life-table analysis, patients who received 400 mg cimetidine nightly during the entire length of the study showed relapse rates of 25%, 36% and 45% after 1, 2 and 3 years respectively. The effect of various prognostic factors on the ulcer relapse rate was examined. Patients who smoked or who were younger than 50 years suffered significantly more relapses and patients with duodenal ulcers also relapsed more frequently. After the open-design long-term maintenance treatment study had been continued over 2 years, one-fifth of the patients who had remained relapse-free were randomly assigned to placebo for one year. In the 3rd year, 36% in the placebo group and 16% of the patients who had continued with cimetidine had relapsed. This difference is statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS)