Use of Omeprazole With NSAID Could Prevent Ulceration: Presented at ACG
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Use of Omeprazole With NSAID Could Prevent Ulceration: Presented at ACG

PHILADELPHIA, PA -- October 23, 2007 -- The risk of gastroduodenal ulceration associated with nonsteroidal anti-inflammatory drugs (NSAIDs) can be reduced by 75% in healthy individuals aged 50 to 75 years if they take proton pump inhibitor (PPI) omeprazole 20 mg daily for 1 week, according to a randomised, double-blind, placebo-controlled study.

Gastroduodenal complications of NSAIDs are a significant cause or morbidity and limit patient compliance with NSAIDs even during short-term treatment, noted study investigators Lawrence Cohen, MD, Associate Clinical Professor of Medicine/ Gastroenterologist, Mount Sinai Hospital, New York, New York, United States.

Because of cardiovascular concerns regarding COX-2 selective NSAIDs, focus has been put on nonselective NSAIDs, such as naproxen, he said during his presentation here on October 14 at the American College of Gastroenterology (ACG) Annual Scientific Meeting. However, the benefits of short-term proton pump inhibition in otherwise healthy older individuals are unproven.

The study's primary endpoint was the incidence of endoscopic ulceration (erosions or ulcerations) at endoscopy.

Patients in the single-site study had not used an NSAIDs in the previous 2 weeks or a PPI in the previous 60 days. All 70 patients received naproxen 500 mg twice daily for 6.5 days and were randomised to omeprazole 20 mg daily (n=35) or placebo (n=35). Patient demographics were similar in both groups.

Overall, 66 patients completed the study. Fewer patients in the naproxen plus omeprazole group developed gastroduodenal ulceration compared with the naproxen plus placebo group (11.8% vs 46.9%, RR =.25, P =.002).

Naproxen plus omeprazole patients also experienced less NSAID-induced dyspepsia, especially non-pain symptoms such as bloating, than those taking naproxen plus placebo.

Dr. Cohen said the results of the study are similar to those of a previously reported study that showed reduced NSAID-induced ulceration associated with PPIs when used for secondary prevention by arthritis patients.

The researchers concluded that coadministration of a PPI in relatively healthy patients aged 50 to 75 requiring short-term non-specific NSAID therapy may be worthwhile.

The study was supported by Pfizer.

[Presentation title: Primary Prevention by Omeprazole 20 mg Daily of the Adverse Gastrointestinal Effects of Short-Term Non-Steroidal Anti-Inflammatory Drug Use in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Study. Abstract 32]

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