MORRISTOWN, N.J., March 7 /PRNewswire/ -- Today at the American College of Cardiology (ACC) in Orlando, FL, investigators from the Women’s Health Study (WHS) reported important new findings demonstrating a significant benefit for aspirin in the prevention of a first stroke in apparently healthy women. Specifically, the study used Bayer(R) Aspirin and showed a 17% reduction in the risk of a first stroke, and a 24% reduction in the risk of an ischemic stroke. Ischemic strokes account for over 80% of all strokes. This finding is particularly important to women, as each year about 40,000 more women than men suffer a stroke. The WHS found that aspirin offered the greatest benefit in women 65 and older -- reducing all major cardiovascular events including heart attack (MI) and ischemic stroke. However, in the total population, which comprised a significant number of younger women (ages 45-55), low-dose aspirin did not demonstrate a significant benefit in preventing first heart attack or cardiovascular death. The cardiovascular component of the WHS was a 10-year randomized trial of the efficacy and safety of aspirin in approximately 40,000 apparently healthy women. Aspirin is currently approved by the Food & Drug Administration for reducing the risk of heart attack, stroke and death in both women and men who have experienced a previous heart attack or stroke, as well as reducing the risk of mortality in patients with a suspected acute MI.
“The Women’s Heath Study is the first large trial to demonstrate a significant benefit of aspirin in the primary prevention of stroke, reinforcing what we know of its efficacy from secondary prevention trials,” said Brigham and Women’s Hospital’s Julie E. Buring, ScD and principal investigator of the Women’s Health Study. “Although not widely recognized, women tend to suffer more strokes than heart attacks as compared to men, and thus these prevention data for low-dose aspirin have important public health implications.”
Additionally, the WHS further supports aspirin’s favorable benefit/risk profile. In fact, while there was a small increase in risk of overall GI bleeds associated with aspirin use, there were no significant differences between aspirin and placebo in risk of stomach upset, fatal GI bleeds or hemorrhagic stroke.
“These findings herald exciting new potential for the primary prevention of stroke, while bolstering existing evidence about the overall cardiovascular benefits of aspirin therapy, particularly in older women,” said C. Noel Bairey Merz, MD, Women’s Guild Endowed Chair in Women’s Health and the medical director of the Cedars-Sinai Women’s Health Program. “However, in the wake of these findings, we must be clear in our communication that an aspirin regimen should not be started or stopped without consulting with a healthcare professional. Indeed, it is vital that our patients who are already on aspirin therapy remain so, and we must continue to conduct careful risk assessments, ensuring that sound clinical decisions drive aspirin recommendations to appropriate patients, while discouraging inappropriate use.”
As these study results should be viewed in the context of adding to the existing body of evidence for primary prevention of cardiovascular events, Dr. Bairey Merz says it is important to remember the evidence for secondary prevention that supports the numerous existing U.S. Food and Drug Administration (FDA) approved vascular indications for aspirin in a range of doses.
“Bayer continues to support the American Heart Association, United States Preventive Services Task Force, American Diabetes Association and other health organizations in advising women to discuss their cardiovascular disease risk with their healthcare provider,” said Erica Peitler, Senior Vice President of Global Strategic Initiatives Bayer’s Consumer Care Division. “We are encouraged by the WHS findings, which confirm aspirin’s cornerstone role in reducing the occurrence of major cardiovascular events. We hope that they will propel more women to have their cardiovascular risk assessed and talk with their doctor about whether aspirin therapy might be appropriate for them. Bayer remains committed to partnering with the medical and scientific communities to advance comprehensive educational and scientific initiatives, such as the WHS, that enhance the current understanding of aspirin’s role in reducing the burden of cardiovascular disease.”
Aspirin is widely recognized for its cardioprotective benefits, which have been amply demonstrated in numerous clinical trials. In the United States, the U.S. Food and Drug Administration (FDA) has approved the use of aspirin to: reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia; reduce the risk of vascular mortality in patients with a suspected acute MI; reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris; reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris.
About the Women’s Health Study
Designed to address gaps in scientific understanding of aspirin’s benefits and risks in women, the Women’s Health Study funded by the National Heart, Lung and Blood Institute (NHLBI) and the National Cancer Institute (NCI), in conjunction with the Brigham and Women’s Hospital and Harvard Medical School, was a 10-year randomized trial testing the efficacy and safety of aspirin in reducing cardiovascular risk in approximately 40,000 apparently healthy women.
About Bayer Consumer Care
Bayer Consumer Care, a division of Bayer HealthCare, is headquartered in Morristown, N.J. Bayer Consumer Care 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. Bayer HealthCare combines the global activities of the Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals divisions. A subgroup of Bayer AG, Bayer HealthCare had sales of approximately 8.9 billion Euro in 2003 and employs about 34,600 people worldwide.
Bayer
CONTACT: Anne Coiley, Bayer Consumer Care, +1-973-254-4607, or+1-201-787-0160; Lauren Mazzella, SENSEI Health, +1-212-631-0505, ext. 18, or+1-917-974-7734, for Bayer
Web site: http://www.senseihealth.com/
