Long-term omeprazole treatment in resistant gastroesophageal reflux disease: Efficacy, safety, and influence on gastric mucosa

Abstract

Background & Aims: The efficacy and safety of long-term acid suppression remains a subject for debate. We report data from patients with refractory reflux esophagitis who were undergoing maintenance therapy with ≥20 mg omeprazole daily for a mean period of 6.5 years (range, 1.4–11.2 years). Methods: Patients with severe reflux esophagitis resistant to long-term therapy with H 2-receptor antagonists and who were not eligible for surgery were evaluated at least annually for endoscopic relapse and histological changes in the gastric corpus. Results: In 230 patients (mean age, 63 years at entry; 36% were ≥70 years), there were 158 relapses of esophagitis during 1490 treatment years (1 per 9.4 years), with no significant difference in relapse rates between Helicobacter pylori–positive and –negative patients. All patients rehealed during continued therapy with omeprazole at the same or higher dose. The annual incidence of gastric corpus mucosal atrophy was 4.7% and 0.7% in H. pylori–positive and –negative patients, respectively, which was mainly observed in elderly patients who had moderate/severe gastritis at entry. In patients with baseline moderate/severe gastritis, the incidences were similar: 7.9% and 8.4%, respectively. Corpus intestinal metaplasia was rare, and no dysplasia or neoplasms were observed. The adverse event profile was as might be expected from this elderly group of patients. Conclusions: Long-term omeprazole therapy (up to 11 years) is highly effective and safe for control of reflux esophagitis. GASTROENTEROLOGY 2000;118:661-669