A non-comparative multicentre study of 105 patients with healed
duodenal ulcers was conducted to determine the effect on
ulcer recurrence of 6 months' maintenance treatment with
roxatidine acetate 75 mg daily. All patients had previously received
roxatidine acetate treatment. 31 patients out of 89 had 32 relapsed
ulcers after 6 months of treatment, which represents an overall relapse rate of around 30%; the relapse rate in smokers was double that of non-smokers. The overall incidence of epigastric
pain did not increase significantly over the period of the trial, although some patients complained of mild
pain when they entered the study despite having endoscopically confirmed healed
ulcers. At the end of the study continuous poor appetite and
pyrosis were reported by 17% and 6% of patients, respectively. Side effects, which included
constipation and diarrhoea, were reported by 4 patients, 1 of whom withdrew from
therapy. There were no clinically significant changes in laboratory values. Thus, maintenance treatment with
roxatidine acetate 75 mg daily proved a safe and effective method of preventing symptomatic
duodenal ulcer relapse.