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Clincal trials indicate NEXIUM can reduce upper GI symptoms in patients using NSAIDS

WILMINGTON, DE, May 12, 2005 Results from two clinical trials, published in the American Journal of Gastroenterology, demonstrate that NEXIUM (esomeprazole magnesium) can reduce upper gastrointestinal (GI) symptoms such as moderate to severe pain, burning and discomfort in the upper abdomen associated with continuous, daily use of non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors.

In the trials, NEXIUM 20 mg and 40 mg significantly improved upper GI symptoms in patients taking NSAIDs, including selective COX-2 inhibitors, versus placebo. Based on a seven-point patient-assessed scale (0 = no pain to 6 = very severe pain), for example, the average change in pain score among NSAID users over 4 weeks was 2.30 (20 mg) and 2.03 (40 mg) vs. 1.64 (placebo) in the first trial (p<0.001), and 2.17 (20 mg) and 2.12 (40 mg) vs. 1.56 (placebo) in the second trial (p<0.001). For patients on COX-2 inhibitors, the mean change was 2.21 and 1.92 vs.1.64 in the first trail, respectively (p<0.05) and 2.20 and 2.24 vs. 1.58, respectively in the second trial (p<0.05).

People who use NSAIDs regularly are at a high risk for upper GI disturbances including dyspepsia, abdominal pain, and heartburn. Although reducing the NSAID dosage or discontinuing therapy might ease GI symptoms, these alterations often are not an option for many patients because of the chronic nature of their underlying condition, said James M. Scheiman, M.D., Division of Gastroenterology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan. These two trials demonstrate that NEXIUM was effective in reducing upper GI symptoms of patients on chronic NSAID therapy.

NEXIUM improved symptoms in as early as the second day of treatment and provided significantly faster symptom relief, compared with placebo. In one trial, 7 consecutive days of symptom relief occurred within an average of 11 and 10 days for patients treated with NEXIUM 20 m
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12-May-2005


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