Prevention of Duodenal Ulcer Relapse by Long-Term Treatment with Omeprazole

Duodenal ulcer is a chronic disease with a high risk of relapse -if left untreated, the relapse rate is 50-80% per year (1). However, the relapse rate can be effectively reduced by inhibition of gastric acid secretion. Although many patients can be managed with episodic therapy, controlled either by the patient or doctor, continuous maintenance treatment is often necessary for patients with severe forms of the disease and those at risk of complications (2). Maintenance therapy with single night-time doses of an Hreceptor antagonist reduces relapse rates from approximately 75% to 25% per year (3). As omeprazole is more effective than the H2-receptor antagonists in the acute treatment of duodenal ulcer, healing virtually all patients within 4 weeks (4), it may also be more effective in the maintenance treatment of duodenal ulcer disease. To date, three studies have reported the effect of omeprazole on relapse rates of duodenal ulcer. A Danish multicentre study involved 195 patients, who were treated with omeprazole, either 10 mg once daily, or 20 mg once daily on Friday, Saturday and Sunday (weekend therapy), or with placebo (5). After 6 months, the remission rates were 67% and 70%, respectively, for those patients receiving omeprazole -significantly higher than in those receiving placebo (17% after 6 months). An Italian multicentre study of 81 patients found that omeprazole, both 10 mg once daily, and 20 mg once daily at weekends (Friday, Saturday and Sunday), was equally effective in preventing relapse. The proportions of patients in remission were 81% and 70%, respectively, after 6 months (6). A multicentre study conducted in South-East Asia recruited 60 patients to receive maintenance therapy with omeprazole, 20 mg once daily, and 63 patients to receive maintenance therapy with placebo (7). Of the 52 patients completing omeprazole therapy, 94% remained in remission after 1 year, compared with 8.5% of the 59 patients remaining in the placebo group -a highly significant difference (p < 0.0001). These studies showed that maintenance therapy with omeprazole is effective, but they did not include comparisons with standard maintenance doses of H,-receptor antagonists (e.g. ranitidine, 150 mg nocte). Therefore, a large multicentre study, covering 16 countries, was started in November 1989 to compare the effects of omeprazole, 10 or 20 mg once daily, with ranitidine, 150 mg nocte, over 1 year. Patients recruited to the study were aged 18-80 years, with a duodena