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IS LONG-TERM OMEPRAZOLE SAFE?

Omeprazole is approved only for short-term use in the U.S. because of concern that potent, long-term acid suppression may induce gastric neoplasia. Yet many clinicians prescribe long-term omeprazole for severe reflux esophagitis because of its proven superiority to H2- blockers. This study evaluated long-term omeprazole in 91 patients with reflux esophagitis refractory to H2-blockers.

Patients received omeprazole for an average of 4 years. The initial dose was 40 mg daily until endoscopic healing (4 to 16 weeks), followed by a maintenance dose of 20 mg daily. Initially, all patients responded to omeprazole, but nearly half eventually needed dose increases to maintain remission after endoscopically documented relapse.

As expected, chronic omeprazole therapy increased serum gastrin levels. Serial gastric biopsies showed that the 10 patients with gastrin levels above 500 ng/l were more likely than other patients to progress to atrophic gastritis and micronodular argyrophil cell hyperplasia (a potential precursor of gastric carcinoid). Comment: This study confirms that omeprazole therapy is effective for several years. Whether the gastric histologic changes found in some chronically treated patients will eventually progress to neoplasia remains to be seen.

— AS Brett

Published in Journal Watch General Medicine August 12, 1994

Citation(s):

Klinkenberg Knol EC et al. Long-term treatment with omeprazole for refractory reflux esophagitis: efficacy and safety. Ann Intern Med 1994 Aug 1 121 161-167.

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