New Data Show High Frequency of Medical Claims for Gastrointestinal Events by Patients on Antiplatelet TherapyReview of Insurance Claims Tracked Ulcers and Bleeding Among 368,000 Patients Prescribed Clopidogrel
TORONTO, May 06, 2008 /PRNewswire/ -- A review of medical claims from more than 70 managed care plans showed that 6.2 percent of patients prescribed the antiplatelet medicine clopidogrel submitted at least one insurance claim for ulcer or gastrointestinal bleeding, according to data released by Cogentus Pharmaceuticals, Inc. here today at the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.
Clopidogrel, marketed as Plavix(R), is among the world's largest-selling prescription medicines and is prescribed to prevent heart attacks and strokes. The retrospective study reported today tracked insurance claims for gastrointestinal adverse events among more than 368,000 patients in the 12 months following their first prescription for clopidogrel.
"This study provides important new information about the frequency of medical attention for gastrointestinal events required by an insured population on antiplatelet therapy," said lead author Dr. Pablo Lapuerta, Chief Medical Officer and Senior Vice President for Clinical Strategy at Cogentus.
"Inhibition of normal platelet function by clopidogrel likely contributed to gastrointestinal complications, particularly in such a real-world setting in which patients often have multiple risk factors," he said. "While it is important for patients to stay on clopidogrel to prevent the progression of coronary heart disease, ulcers and bleeding can result in patients not taking their heart disease medicine."
Experts believe that multiple factors contribute to ulcer disease and its complications. Studies have shown an increased risk of gastrointestinal bleeding among patients using antiplatelet 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.
Cogentus Pharmaceuticals, Inc., of Menlo Park, CA, is a privately held specialty pharmaceutical company founded in 2006. Cogentus (http://www.cogentus.net) is committed to becoming a premier developer of innovative, fixed-dose combination prescription medicines serving unmet medical needs that drive significant commercial opportunities.
COGENT stands for the Clopidogrel and the Optimization of Gastrointestinal Events Trial. The program is expected to enroll more than 4,000 patients at hundreds of sites in the United States, Canada, Europe and South America. The COGENT program is designed to measure the incidence of upper gastrointestinal bleeding and ulcers in patients who take CGT-2168 and aspirin compared with patients who take clopidogrel and aspirin. The vast majority of patients who take clopidogrel also take aspirin.
Plavix(R) is a registered trademark of Sanofi-Aventis.
CONTACT: Mariann Caprino, Corporate Communications of CogentusPharmaceuticals, +1-650-543-4719
Web site: http://www.cogentus.net/
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Posted: May 2008