Treatment reduces gastric ulcers in at-risk patients using long-term NSAIDS

Clinical trial data, as highlighted in next month's American Journal of Gastroenterology, demonstrate reduced gastric ulcer risk in patients taking

March 27, 2006 – Results from two clinical trials, to be published in the April 2006 edition of the American Journal of Gastroenterology, indicate that esomeprazole magnesium can reduce the incidence of gastric (stomach) ulcers in patients at risk of developing gastric ulcers and who regularly take either non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2-selective NSAIDs.

NSAIDs are a class of pain relief medications that include traditional, non-selective drugs, such as ibuprofen, naproxen and aspirin, and newer COX-2-selective agents. Nonselective NSAIDs are known for increasing the risk of gastric ulcers, particularly among older patients who take them regularly or who have a history of gastric ulcers.

Pooled data from the double-blind, randomized, six-month trials showed that significantly fewer patients taking either NEXIUM 20 mg or NEXIUM 40 mg, in addition to their regular non-selective NSAID/selective-COX-2 therapy, developed an ulcer at six months, compared to those taking a placebo (5.2 percent and 4.6 percent, respectively, vs. 17 percent, p<0.001). These differences were seen as early as the first month of treatment and maintained throughout the study duration.

"Paradoxically, NSAID use is common among patients at high risk for gastric ulcers or other complications associated with these medications. Although COX-2-selective drugs generally cause fewer gastric ulcers than non-selective NSAIDs, these events aren't completely eliminated, and the residual side-effect rate still may be high," said James M. Scheiman, MD, Division of Gastroenterology, Department of Internal Medicine, University of Michigan. "Data from the two trials showed that NEXIUM was effective in reducing stomach ulcers in at-risk patients who require chronic NSAID treatment."

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About NSAID-ulcer Risk
Chronic NSAID use is a common cause of gastric ulcers and has been associated with side effects ranging from indigestion to potentially life-threatening stomach bleeding.

Of the more than 14 million Americans who use NSAIDs regularly to treat chronic pain, up to 25% may be affected by NSAID-related ulcers. Each year, there are an estimated 103,000 hospitalizations and 16,500 deaths in the United States attributed to complications from NSAID-associated gastric ulcers. Among the elderly, NSAID use accounts for nearly one third of gastric-ulcer-related hospitalizations, with an associated four-fold increased risk of death.

AstraZeneca R&D, Sweden, funded the study through a research grant. AstraZeneca is the maker of Nexium®.

This study is published in the American Journal of Gastroenterology. Media wishing to receive a PDF of the study please contact: medicalnews@bos.blackwellpublishing.net.

James Scheiman, MD is currently Associate Professor and Director of the Endoscopic Ultrasound Program at the University of Michigan Medical School. He currently studies Gastroesphogeal Reflux Disease(GERD), managements strategies to reduce NSAID-induced ulcer disease, and the clinical impact of H. pylori testing and treatment in suspected peptic ulcer disease.

About the American Journal of Gastroenterology
The clinical journal in gastroenterology: The American Journal of Gastroenterology meets the day-to-day demands of clinical practice. Aimed at practicing clinicians, the journal's articles deal directly with the disorders seen most often in patients. The journal brings a broad-based, interdisciplinary approach to the study of gastroenterology, including articles reporting on current observations, research results, methods of treatment, drugs, epidemiology, and other topics relevant to clinical gastroenterology.

About the American College of Gastroenterology
The American College of Gastroenterology (ACG) was founded in 1932 to advance the scientific study and medical practice of diseases of the gastrointestinal (GI) tract. The College promotes the highest standards in medical education and is guided by its commitment to meeting the individual and collective needs of clinical GI practitioners.

About Blackwell Publishing
Blackwell Publishing is the world's leading society publisher, partnering with more than 665 academic, medical, and professional societies. Blackwell publishes over 800 journals and, to date, has published close to 6,000 text and reference books, across a wide range of academic, medical, and professional subjects


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