ATLANTA, March 12 /PRNewswire/ -- Data from a long-term study released today solidifies aspirin's role as the preeminent antiplatelet therapy in the prevention of heart attack and stroke. The results of the Clopidogrel for High Atherothrombotic Risk and Ischaemic Stabilization, Management, and Avoidance (CHARISMA) trial, which were presented today at the 55th Annual Scientific Session of the American College of Cardiology in Atlanta, Georgia, USA, and published online in an advance issue of the New England Journal of Medicine(1), highlight the primacy of aspirin among antiplatelet agents and add to the robust body of evidence supporting aspirin's role in cardioprevention.
Overall, the study showed that there was no significant benefit to adding clopidogrel to aspirin therapy in a wide range of patients. Furthermore, since patients who took clopidogrel had an increased risk of bleeding, the long-term use of combination antiplatelet therapy may not be warranted in most patients.
"CHARISMA reaffirms the favorable benefit-to-risk and benefit-to-cost ratio of aspirin in the treatment and prevention of heart attack and stroke," said Charles H. Hennekens, M.D., Professor at Florida Atlantic University and the University of Miami School of Medicine, who pioneered many early landmark trials of aspirin.
As described in the New England Journal of Medicine's accompanying editorial, The Charisma Sub Groups and the Subgroups of CHARISMA, "Antiplatelet therapy with aspirin ... has earned its rightful place as a cornerstone of treatment for reducing cardiovascular events in patients with established vascular disease." The editorial authors note: " ... the absence of a clear benefit in terms of clinical outcome, coupled with the increased rate of bleeding (as well as the economic considerations related to the long- term use of clopidogrel), provides a robust answer to the central question of the trial and argues against the use of dual antiplatelet therapy in this patient population."(2)
"These findings are particularly welcome news worldwide, with cardiovascular disease rising from the fifth to the leading cause of death. Aspirin is both effective and affordable for the millions of people worldwide who could benefit. Wider utilization is needed in both developing and developed countries, like the US," Hennekens concluded.
The CHARISMA trial is an international, multicenter, double-blinded, placebo-controlled study involving 15,603 patients aged 45 years or older who were at high risk of heart attack, stroke or death from cardiovascular disease. The study was designed to assess whether adding clopidogrel (75 mg/day) to aspirin therapy (75-162 mg/day) provided any benefit over aspirin monotherapy in preventing the occurrence of those events.
The study's efficacy results showed that the addition of clopidogrel to aspirin therapy did not result in a significant lowering (p =0.22) of risk of the primary endpoint, the combined risk of heart attack, stroke or cardiovascular death (6.8 percent in the clopidogrel plus aspirin group and 7.3 in the aspirin-only group -- a difference that was not statistically significant). Additionally, the rate of moderate-to-severe bleeding was increased in the patients taking clopidogrel with aspirin compared to the rate in those taking aspirin alone.
Aspirin: The Unsurpassed Antiplatelet Gold Standard
Aspirin is the most studied antiplatelet agent, with more than a 100-year track record of efficacy and safety. As the cornerstone antiplatelet therapy for reducing the risk of cardiovascular events, time-tested aspirin is well recognized for its benefits as first-line therapy across a wide cardiovascular risk continuum because of its proven efficacy, safety and cost-effectiveness - benefits that have been demonstrated in more than 200 trials involving over 200,000 patients, including CHARISMA.
About Bayer Consumer Care
Bayer's Consumer Care Division, the maker of Bayer(R) Aspirin, is committed to furthering the science and understanding of the appropriate use of aspirin for cardioprevention. Bayer Consumer Care is a division of Bayer HealthCare LLC, headquartered in Morristown, N.J. Bayer's Consumer Care Division is among the largest marketers of over-the-counter medications and nutritional supplements in the world. Some of the most trusted and recognizable brands in the world today come from the Bayer portfolio of products. These include Bayer(R) Aspirin, Aleve(R), Alka-Seltzer Plus(R), Bactine(R), RID(R), Phillips(R)' Milk of Magnesia, Midol, Alka-Seltzer(R), One-A-Day(R) vitamins and Flintstones(TM) vitamins.
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry based in Leverkusen, Germany. Bayer HealthCare generated sales amounting to some 9.4 billion euros and employed 33,800 people worldwide in 2005. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals divisions. The new Pharmaceutical Division was established on January 1, 2006, and comprises the former Biological Products and Pharmaceutical Division. Pharmaceuticals now has three business units: Hematology/Cardiology, Oncology and Primary Care. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.
Disclosure: Dr. Hennekens is an independent scientist who is Principal Investigator of two investigator initiated grants funded by Bayer and has served as consultant to various drug companies, including Bayer. His commentaries represent his own independent scientific viewpoint.
(1) Bhatt DL, Fox KAA, Hacke W, et al. Clopidogrel and aspirin versus
aspirin alone for the prevention of atherothrombotic events.
N Engl J Med 2006;354.
(2) Pfeffer MA, Jarcho JA. The charisma of subgroups and the subgroups of
CHARISMA. N Engl J Med 2006;354.
Bayer HealthCare LLC