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New Data Show High Frequency of Medical Claims for Gastrointestinal Events by Patients on Antiplatelet Therapy
Date:5/6/2008

et medicines such as clopidogrel or aspirin, and an even higher risk for patients taking clopidogrel in combination with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS). One study showed that treatment with clopidogrel augmented bleeding caused by NSAIDS, an effect attributed to the inhibition of platelets by clopidogrel.

Increasing age is a recognized risk factor for ulcer disease, and clopidogrel is commonly prescribed for elderly patients with atherosclerosis. In the insurance claim review, 72 percent of patients were over 60 years of age. Information about concurrent aspirin use, which is common among patients with cardiovascular disease and particularly among clopidogrel users, was not available. A higher incidence of bleeding side effects was seen in women -- 7.2 percent filed medical claims for an ulcer or gastrointestinal bleeding while 5.4 percent of men filed claims.

"The surprisingly high frequency of these claims raises a significant public health concern," said Dr. Byron Cryer, the John C. Vanatta III Professor of Medicine and Associate Dean for Minority Affairs at Southwestern Medical School in Dallas. "Until recently, gastrointestinal side effects in patients taking antiplatelet therapy have been largely underappreciated by physicians, who are appropriately focused on preventing future heart attacks. We need to address this problem to help keep patients on their medical treatment regimens."

Dr. Cryer is a member of the Scientific Steering Committee overseeing COGENT, the global Phase 3 clinical trial program sponsored by Cogentus. The COGENT program will evaluate the efficacy and safety of Cogentus's lead product, CGT-2168, which combines clopidogrel and the gastroprotectant omeprazole. CGT-2168 is designed to maintain the cardiovascular benefits of antiplatelet therapy while reducing its potentially serious gastrointestinal side effects.

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SOURCE Cogentus Pharmaceuticals, Inc.
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