This website discusses uses of aspirin not approved by the Food and Drug Administration.
Older Women Saw Greatest and Most Consistent Benefit of Aspirin with Reduction of All Major Cardiovascular EventsBayer Aspirin showed a 17% reduction in the risk of a first stroke, and a 24% reduction in the risk of an ischemic stroke, which accounts for 80% of all strokes
Although in younger women aspirin did not demonstrate a significant benefit in prevention of a first heart attack or cardiovascular death, aspirin reduced all major cardiovascular events including heart attack and ischemic stroke among women 65 or older
No significant difference between aspirin and placebo in risk of stomach upset, fatal gastrointestinal (GI) bleeds or hemorrhagic stroke, although there was a small increase in risk of overall GI bleeding
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® 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 Health 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 gastrointestinal (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.
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.
