Daily low-dose (100 mg) aspirin did not prolong healthy, independent living — that is, life free of dementia or persistent physical disability — in a large clinical study undertaken to determine the risks and benefits of aspirin in healthy older adults without previous cardiovascular events.

The initial findings from the ASPirin in Reducing Events in the Elderly, or ASPREE, trial, partially supported by the National Institutes of Health’s National Institute on Aging and National Cancer Institute, were published online Sunday in three papers in the New England Journal of Medicine.

“Clinical guidelines note the benefits of aspirin for preventing heart attacks and strokes in persons with vascular conditions such as coronary artery disease,” NIA Director Richard J. Hodes, M.D., said in a statement. “The concern has been uncertainty about whether aspirin is beneficial for otherwise healthy older people without those conditions. This study shows why it is so important to conduct this type of research, so that we can gain a fuller picture of aspirin’s benefits and risks among healthy older persons.”

The risk of dying from a range of causes, including cancer and heart disease, varied among study participants and will require additional analysis and follow-up the investigators said.

As research continues, older adults should follow the advice from their own physicians about daily aspirin use, Evan Hadley, M.D., director of NIA’s Division of Geriatrics and Clinical Gerontology, said in a statement. The new findings do not apply to people with a proven indication for aspirin use, such as stroke, heart attack or other cardiovascular disease, the NIH said.

The trial began in 2010 and included 19,114 older adults in Australia and the United States who were studied for an average of 4.7 years. At study enrollment, participants could not have dementia or a physical disability and had to be free of medical conditions requiring aspirin use.

Highlights of the study:

  • Among participants randomly assigned to take aspirin, 90.3% remained alive at the end of the treatment without persistent physical disability or dementia, compared with 90.5% of those taking a placebo (dummy pill). Rates of physical disability were similar, and rates of dementia were almost identical in both groups.
  • The group taking aspirin had an increased risk of death compared with the placebo group: 5.9% of participants taking aspirin and 5.2% taking placebo died during the study.
  • Rates for major cardiovascular events — including coronary heart disease, nonfatal heart attacks, and fatal and nonfatal ischemic stroke — were similar in the aspirin and the placebo groups. In the aspirin group, 448 people had cardiovascular events, compared with 474 people in the placebo group.
  • Significant bleeding — a known risk of regular aspirin use — also was measured. The investigators noted that aspirin was associated with a significantly increased risk of bleeding, primarily in the gastrointestinal tract and brain. Clinically significant bleeding — hemorrhagic stroke, bleeding in the brain, gastrointestinal hemorrhages or hemorrhages at other sites that required transfusion or hospitalization — occurred in 361 people (3.8%) on aspirin and in 265 (2.7%) taking the placebo.

The New England Journal of Medicine articles can be accessed at no charge online:

“Effect of Aspirin on All-Cause Mortality in the Healthy Elderly”

“Effect of Aspirin on Disability-free Survival in the Healthy Elderly”

“Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly”

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