Roxatidine acetate in the long term maintenance of gastric ulcers.

A non-comparative multicentre study of 78 patients with healed gastric ulcers who had received roxatidine acetate was conducted to determine the ulcer recurrence rates during 6 months' maintenance therapy with roxatidine acetate 75 mg at night. Gastric ulcer relapses occurred in 35% of patients, representing a worst possible outcome estimate, with no significant differences between smokers and non-smokers although heavy smoking appeared to increase the rate of relapse. The incidence of epigastric pain did not significantly increase over the duration of therapy and while some patients complained of mild pain at the start of the trial all subjects had endoscopically confirmed healed ulcers. The consumption of antacids for symptom relief was low, reaching an average of 0.75 tablets a day which was insufficient to influence intragastric pH. Continuous poor appetite and pyrosis were reported by about 5% of subjects. Of 2 patients who complained of mild to moderate side effects, 1 discontinued treatment. In addition, there were no clinically significant changes in haematological and biochemical variables. Thus, maintenance therapy with roxatidine acetate 75 mg at night is safe and generally effective in preventing symptomatic relapse.