Navigation Links
New Data Show High Frequency of Medical Claims for Gastrointestinal Events by Patients on Antiplatelet Therapy

Review of Insurance Claims Tracked Ulcers and Bleeding Among 368,000

Patients Prescribed Clopidogrel

TORONTO, May 6 /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 ( 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.

SOURCE Cogentus Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. New Data Reveal Topical Divigel(R) (estradiol gel) 0.1% Significantly Reduces Frequency and Severity of Hot Flashes
2. Quantum Immunologics, Inc. and the South Alabama Medical Science Foundation Announce an Early Clinical Evaluation of a Novel Immuno-therapeutic Vaccine for Treating Advanced Human Breast Carcinomas
3. Delcath Expands Phase III Trial for Metastatic Melanoma to Include University of Maryland Medical Center
4. Tepha Announces First Human Usage of Medical Devices Derived from New Class of Resorbable Polymers
5. Rib-X Pharmaceuticals Renews Collaborative Agreement with the Medical Research Council
6. Nektar Therapeutics to Present Positive Data at Upcoming Medical and Scientific Meetings
7. Columbia University Medical Center and Rosetta Genomics Announce Columbia Universitys Submission of the First Cancer Diagnostic Test Based on Rosetta Genomics Proprietary MicroRNA Technology for Approval to the New York State Department of Health Clinica
8. Orqis(R) Medicals Cancion(R) System Significantly Increases Cardiac Performance
9. New York-Presbyterian/Weill Cornell is First New York Medical Center to Offer Tantalus Clinical Trial to Diabetes Patients
10. Stem Cell Research Provides Medical Breakthrough to Repair Heart Cell Damage Created by a Heart Attack
11. Valor Medical Announces First Human Implant of Neucrylate AN(TM) for Treatment of Cerebral Aneurysm
Post Your Comments:
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 ... the addition of the "2016 Future Horizons ... Monitoring (TDM) Market: Supplier Shares, Country Segment Forecasts, ... offering. --> ... comprehensive analysis of the Japanese therapeutic drug monitoring ...
(Date:11/26/2015)... 2015 Research and Markets ( ) ... Care Market by Type (Dressings, Therapy Devices, Active Wound ... Out-Patient Facility), and Geography - Global Forecast to 2020" ... --> --> The purpose of this ... of the global advanced wound care market. It involves ...
(Date:11/26/2015)... 26, 2015 ... "Radioimmunoassay Market by Type (Reagents & ... Academics, Clinical Diagnostic Labs), Application (Research, Clinical ... 2020" report to their offering. ... addition of the "Radioimmunoassay Market by ...
Breaking Medicine Technology:
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... potentially more aggressive than those found on mammography, according to a study published ... of additional cancers not seen on mammography may necessitate a change in treatment. ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... sauna parts and accessories. , Sauna accessories help improve the bather experience in ... personality. From basic styles for the purist looking for simplicity in design to ...
(Date:11/25/2015)... ... November 25, 2015 , ... According to an article ... being more and more widely heralded as a breakthrough for performing hernia repairs. The ... over traditional laparoscopic surgery is that it can greatly reduce the pain that a ...
(Date:11/25/2015)... ... ... The McHenry County law firm of Botto Gilbert Lancaster, PC ... Botto and Alex C. Wimmer. Attorneys Botto and Wimmer represented the claimant David Adcock ... , According to court documents, Adcock testified that on May 10, 2010 he sat ...
(Date:11/25/2015)... ... November 25, 2015 , ... Brillianteen, McGaw YMCA’s student-produced ... in its 65th Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions for ... years, Brillianteen has been a treasured tradition for numerous families in the Evanston ...
Breaking Medicine News(10 mins):