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(esomeprazole, AstraZeneca)

A proton pump inhibitor (PPI) approved for reducing the risk of gastric ulcers associated with continuous NSAID therapy in patients at a greater than normal risk of developing gastric ulcers. First marketed in 2001 for treating gastroesophageal reflux disease and other indications, this is the second of the five PPIs available in the United States approved for an NSAID-related gastric ulcer claim; the other is Prevacid (lansoprazole).

* Recommended Dosage: 20 mg or 40 mg once a day for up to 6 months (controlled studies have lasted only 6 months). Taken at least 1 hour before meals.

* Special Considerations: PPIs in general are well tolerated, with one available over the counter, noted James Scheiman, M.D., professor of medicine in the division of gastroenterology at the University of Michigan, Ann Arbor.

* Comment: Approval was based on two 6-month endoscopic studies of 1,429 patients (age 19-89) at high risk for gastric ulcers (they were 60 years or older and/or had had a gastric or duodenal ulcer within the previous 5 years). The patients were taking a nonselective or a selective cyclooxygenase-2 (COX-2) NSAID continuously. In one study, 95%-97% of those on 20 mg or 40 mg of Nexium had no gastric ulcers (on endoscopy) during the study vs. 88% of those on placebo. In the second study, 95% of those on 20 mg or 40 mg had no gastric ulcers, vs. 83% of those on placebo.

The use of PPIs with NSAIDs "should be considered a viable treatment alternative' to selective COX-2 inhibitors, particularly with the recent warnings about the increased risk of cardiovascular events associated with Bextra (valdecoxib) and Celebrex (celecoxib), and the withdrawal of Vioxx (rofecoxib) from the market, said Dr. Scheiman, one of the lead investigators in the Nexium trials. Some evidence suggests this approach is "tremendously underutilized," added Dr. Scheiman, a consultant to AstraZeneca, and manufacturers of COX-2 inhibitors and other PPIs.
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Title Annotation:NEW & APPROVED
Author:Mechcatie, Elizabeth
Publication:Internal Medicine News
Geographic Code:1USA
Date:Jan 15, 2005
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