EROSIVE ESOPHAGITIS - OUTCOME OF REPEATED LONG-TERM MAINTENANCE TREATMENT WITH LOW-DOSE OMEPRAZOLE 10 MG OR PLACEBO

Aims-To investigate the efficacy of daily maintenance treatment with o meprazole 10 mg in reducing the relapse rate of healed erosive oesopha gitis. Methods-Three hundred patients with erosive oesophagitis (grade 2 or greater) received omeprazole 20 mg daily for 12 weeks, followed by 40 mg daily for a further 12 weeks if required. After healing, pati ents were randomised to double blind treatment with omeprazole 10 mg d aily or placebo for up to 18 months. On relapse the treatment cycle wa s repeated, Results-The cumulative healing rate at 12 weeks in the ini tial healing period was 95%, and 96% and 98% on rehealing courses afte r relapse in the first and second maintenance periods respectively. Af ter 12 weeks of treatment, 98% of patients were free from heartburn an d 97% were free of all reflux related symptoms. Relapse in the subgrou p of patients who relapsed in both maintenance periods was infrequent an omeprazole 20 mg daily: only 9% at two years, Gastrin concentration s rose above normal in one third of patients. One patient had linear h yperplasia of endocrine cells and another had micronodular hyperplasia . There were no side effects definitely attributable to omeprazole. Co nclusion-Maintenance treatment with omeprazole 10 mg daily keeps about 60% of patients with erosive oesophagitis in prolonged remission, Pat ients relapsing once are likely to do so again; they can subsequently be treated effectively with omeprazole 20 mg daily.