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.