2 OMEPRAZOLE-BASED HELICOBACTER-PYLORI ERADICATION REGIMENS FOR THE TREATMENT OF DUODENAL-ULCER DISEASE IN GENERAL-PRACTICE

Background: Helicobacter pylori is the main acquired factor in the pat hogenesis of duodenal ulcer disease. Methods: This multicentre study c onducted in 32 general practice centres in the UK and Ireland was a do uble-blind, placebo-controlled, randomized, parallel-group comparison of triple therapy (n = 98: omeprazole 40 mg once daily and amoxyciIlin 1 g b.d. for 2 weeks, and metronidazole 400 mg t.d.s. for the first w eek and dual therapy (n = 85: omeprazole 40 mg once daily and amoxycil lin 1 g b.d. for 2 weeks, with placebo during the first week) for the eradication of H. pylori in patients with symptomatic duodenal ulcer d isease. Patients who were successfully treated entered a followup phas e for 12 months to assess symptomatic relapse and use of health-care r esources, Results: Eradication of H. pylori based on a second C-13-ure a breath test was successful in 95% (95% confidence interval (CI) = 90 -100%) of patients receiving omeprazole triple therapy and 53% (95% CI = 41-65%) of those receiving omeprazole dual therapy (P < 0.0001 betw een groups, all data available analysis). The all-patients-treated ana lysis gave eradication rates of 80 and 44% for omeprazole triple thera py and omeprazole dual therapy, respectively. Symptomatic relapse occu rred in 16% (18/116) of the H. pylori-negative patients who entered th e 12-month follow-up period, and there were significant reductions in the number of consultations, investigations and prescriptions relating to upper gastrointestinal symptoms compared with the 12 months prior to the eradication therapies (all P < 0.0001). The two treatment strat egies were comparable in terms of the number of adverse events reporte d. Conclusions: Omeprazole triple therapy provides a highly effective treatment for the eradication of H. pylori infection in patients in ge neral practice, with an adverse event profile similar to that seen wit h omeprazole dual therapy. The successful eradication of H. pylori wit h these omeprazole regimens results in a significant decrease in the u se of health-care resources in the 12 months following treatment.