Maintenance therapy of gastroesophageal reflux disease patients with omeprazole

Gastroesophageal disease (GERD) is a chronic disease with an increasing prevalence. The purpose of this study was to establish the relationship between rate of relapses and maintenance therapy strategies in patients with gastroesophageal reflux disease.

Two hundred sixteen patients were included in a prospective randomized study. Patients meeting the criteria for GERD and successfully completing acute therapy were included in the study. Patients with NERD and those with mild ERD (LA grade A and LA grade B) were randomly assigned to group A1 or A2. Group A1 patients were allocated to on-demand therapy with omeprazole 20 mg. Group A2 patients received continuous therapy with omeprazole 10 mg daily. Patients with ERD LA grade C and LA grade D were allocated to group B and treated with 20 mg of omeprazole daily. Clinical control visits were scheduled every three months. The last visit, at 12 months, included mandatory gastroscopy. In cases of suspected relapse, additional control visits and gastroscopy were done outside the regular schedule. GERD relapses and quality of life between different groups of patients were the primary outcome of the study.

Of the total number of patients, 94 were allocated to group A1, 102 to group A2, and 20 to group B. In the per-protocol analysis, the cumulative relapse rate at 12 months was 34.9% (95% CI 24.6%-45.2%) in group A1, and 15.3% (95%, CI 7.6%-22.9%) in group A2 (p < 0.05), and 40% (intention to treat; 95% CI 18.55-61.5%) in group B. No statistically significant differences were found between the groups with regard to the health-related quality of life evaluation. None of the patients experienced serious adverse reactions during the study period.

In patients without esophagitis or with esophagitis LA grade A at baseline, receiving 10 mg doses of omeprazole, a statistically significantly lower relapse rate was observed as compared to the patients with on-demand therapy. In patients with esophagitis LA grade B no differences in the relapse rate were found, without regard to the regimen used. Patients with esophagitis LA grade C and LA grade D had a high rate of relapse, often asymptomatic, despite therapy with 20 mg omeprazole.