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Senior Citizens Only Women to Protect Heart with Aspirin

New study says aspirin does reduce risk of stroke for all women

March 8, 2005 – The decision to take a daily aspirin to avoid a heart attack is certainly best left to personal physicians, but even they may be confused by all the studies released recently. The study released yesterday focused on women and says it is good for older women – those 65 and older. But, it does not help women aged 45 to 64. Earlier studies have reported it helps men of all ages.

The study found that aspirin offered the greatest benefit in women 65 and older - reducing all major cardiovascular events including heart attack (MI) and ischemic stroke.

“The greatest benefit appeared to be in women 65 and older,” said Dr. Elizabeh G. Nagel, Director of the Nationa Heart, Lung and Blood Institute. “In this sub-group, low-dose aspirin reduced the risk of major cardiovascular events by 26 percent. However, the benefits of low-dose aspirin therapy must be weighed against the risk of an increased chance of internal bleeding, a well-known side effect of aspirin use.

“The bottom line is that many women, especially those 65 and older, may benefit from taking low-dose aspirin every other day to prevent stroke,” she said. “But it is important for women to weigh the risk and benefits of taking aspirin and to consult with their doctor.”

The Women's Health Study was 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.

The study also says the low-dose aspiring (“baby aspirin”) may reduce the risk of a stroke caused by blocked blood vessels in the brain for all ages. It is also apparently beneficial for people who have already suffered a heart attack in helping prevent another.

The investigators from the Women's Health Study (WHS) reported these new findings and what may be the most important news is the significant benefit from aspirin in the prevention of a first stroke in apparently healthy women.

Specifically, the study showed a 17% reduction in the risk of a first stroke, and a 24% reduction in the risk of an ischemic stroke, according to a news release by Bayer Aspirin, which says their product was used in the study.

 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.

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.

"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," she added.

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."

Additional Expert Opinions of the Study

Thomas A. Pearson, MD, MPH, PhD, member of the board the World Heart Federation and author of the American Heart Association guidelines for the primary prevention of heart disease and stroke.

This study has particularly important implications for reducing the burden of cardiovascular disease worldwide, underscoring aspirin's utility and safety even in low- to moderate-risk persons. Furthermore, these findings are especially useful in development of global guidelines that broaden the appropriate use of this remarkably inexpensive drug.

It is vital that healthcare professionals are involved in any individual's decision to take aspirin to stave off cardiovascular events such as heart attack or stroke. An aspirin regimen should never be started or stopped without consulting with a healthcare professional. As doctors and researchers continue to build a solid basis of knowledge of aspirin's potential benefits and remain mindful of the risks associated with any effective treatment, we should seek to ensure that people who can benefit from aspirin treatment receive it.

DR FREEK VERHEUGT, Fellow, European Society of Cardiology, Chairman, Professor of Cardiology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

Most studies have been done in men because men between the age of 40 and 65 have more cardiovascular disease than women. We weren't sure if the protective effects of aspirin in men also were present in women over the age of 50.

We clearly see now there is a preventive effect in women between 50 and 65 with regard to stroke. In women over the age of 65, the protective effect also has now been seen in regard to myocardial infarction as it has in men.

The data from this study do not conflict with earlier data. This trial studied healthy women with a mean age of 54 years, which is exceptionally young for women to develop heart disease. But in women over 65, the study showed the benefits of aspirin are as big as in men from the age of 50.

I think what is really encouraging is the prevention of stroke. That is new and has never been seen before with aspirin. Stroke is so catastrophic to the patient and her family that a very cheap and effective means to prevent it is very welcome in women.

CHARLES HENNEKENS, MD, DrPH, Founding Principal Investigator, Women's Health Study, Professor of Biomedical Sciences, Florida Atlantic University, Miami, Fla.

The study's major finding is that it demonstrates that aspirin can reduce the risk of a first stroke. We've been able to demonstrate this in people who have had heart attacks or strokes, but never before in apparently healthy people.

Today, cardiovascular disease kills one in two Americans and one in two people in most of the rich countries. It kills less than one in three in most of the poor countries, but in the next 10-15 years it's going to become the leading killer in the world. So agents that are effective and relatively safe and inexpensive will have a large clinical and public health impact. So the wider and more appropriate use of aspirin in the treatment and prevention of cardiovascular disease can avoid many premature deaths in secondary prevention and many first heart attacks and strokes in primary prevention.

Women over 65 in the Women's Health Study comprised less than 10% of the study population and over 30% of the endpoints. Heart disease becomes the leading killer of men in the United States by age 45 but women by age 65. Therefore in the population that we could demonstrate it, we showed that aspirin prevents heart attacks as well as strokes.

With respect to advice for apparently healthy women and men, I think you've got to see your healthcare provider about the use of aspirin. But I think based on the evidence we have today, that among men over 50 and women over 60 there are many, many who would be candidates for aspirin, based on their absolute risk of getting a heart attack or stroke. I think we need wider and more appropriate utilization of aspirin in conjunction with a decision by the healthcare provider.

DR. MAGDA HERAS, Fellow, European Society of Cardiology

Senior Cardiology Specialist, Clinic Barcelona Hospital Universitari, Barcelona, Spain

The most important results of the study are a reduction of 17% in the occurrence of stroke and specifically a reduction of 24% in the most common type of stroke. On the other hand, we see that in the group of women over age 65, there is a reduction of 34% in heart attacks. This, too, is a very, very important result.

I believe the results of this study, which was carried out on women, basically American nurses, are relevant and can be applied to other types of communities, such as Spain or South America. We still don't know of any great differences in these communities, for example, regarding the effect of aspirin on the occurrence of cardiovascular problems. Therefore I have no doubt in thinking that these results can be applied directly to our local communities.

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