NEXIUM (REG) Can Reduce Upper GI Symptoms In Patients Using NSAIDS, Clincal Trials Indicate

Main Category: GastroIntestinal / Gastroenterology
Article Date: 13 May 2005 - 0:00 PST

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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 mg and 40 mg, respectively, versus 17 days for placebo. In the other trial, 7 consecutive days of symptom relief occurred within an average of 10 and 11 days for patients treated with NEXIUM 20 mg and 40 mg, respectively, versus 21 days for placebo.

In addition, over the four week treatment period, the proportion of symptom-free days was significantly higher for patients treated with NEXIUM versus placebo in both trials (31 percent and 29 percent, vs. 21 percent, and 29 percent and 27 percent, vs. 14 percent in the two trials). More patients treated with NEXIUM (20 mg or 40 mg) also reported improvements on an overall treatment assessment after four weeks of treatment, versus placebo (70.6 percent and 56.8 percent for NEXIUM 20 mg, and 61.1 percent and 54.7 percent for NEXIUM 40 mg, compared with 47.7 percent and 40.9 percent for placebo in these trials).

About the Trials The clinical research trials were two identical, randomized, double-blind, placebo-controlled trials involving a total of 595 and 554 patients, respectively, who were continuous NSAID users and who did not have gastric ulcers, erosive esophagitis or H. pylori infection. Approximately one-third of the patients in both trials (30 percent, 38 percent) were taking only selective COX-2 inhibitors. In the trials, patients received NEXIUM 20 mg or 40 mg or placebo.

In both trials, the safety profile of NEXIUM 20 mg and 40 mg among continuous NSAID users was similar to placebo.

NEXIUM (esomeprazole magnesium) delayed-release capsules

NEXIUM is indicated for reducing the risk of gastric (stomach) ulcers developing among at-risk patients on continuous NSAID therapy. Patients are considered to be at risk if they are 60 and over, or if they have a history of previous stomach ulcer. It also is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease. NEXIUM is approved for healing and maintenance of erosive esophagitis. Most erosions heal in 4 to 8 weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions.

The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. For full prescribing information for NEXIUM please visit http://www.purplepill.com

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com

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