In a large clinical trial to determine the risks and benefits of daily low-dose aspirin in healthy older adults without previous cardiovascular events, aspirin did not prolong healthy, independent living (life free of dementia or persistent physical disability).

Risk of dying from a range of causes, including cancer and heart disease, varied and will require further analysis and additional follow-up of study participants. These initial findings from the Aspirin in Reducing Events in the Elderly (ASPREE) trial, partially supported by the National Institutes of Health, were published online on September 16, 2018, in three papers in The New England Journal of Medicine.

ASPREE is an international, randomized, double-blind, placebo-controlled trial that enrolled 19,114 older people (16,703 in Australia and 2,411 in the United States).

The study began in 2010 and enrolled participants aged 70 and older; 65 was the minimum age of entry for African-American and Hispanic individuals in the United States because of their higher risk for dementia and cardiovascular disease.

Dementia or physical disability

At study enrollment, ASPREE participants could not have dementia or physical disability and had to be free of medical conditions requiring aspirin use. They were followed for an average of 4.7 years to determine outcomes.

"Clinical guidelines note the benefits of aspirin for preventing heart attacks and strokes in persons with vascular conditions such as coronary artery disease," said NIA Director Richard J. Hodes, M.D.

"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," said Hodes.

The team of scientists was led by John J. McNeil, M.B.B.S., Ph.D., head of the Department of Epidemiology and Preventive Health at Monash University, Melbourne, Australia, and Anne M. Murray, M.D., director of the Berman Center for Outcomes and Clinical Research at Hennepin Healthcare in Minneapolis.

The research was supported in part by the National Institute on Aging (NIA) and the National Cancer Institute (NCI), both parts of the NIH. The Australian component of the study also received funding from the Australian National Health and Medical Research Council and Monash University.

Aspirin and placebo were supplied by Bayer, which had no other involvement with the study. In the total study population, treatment with 100 mg of low-dose aspirin per day did not affect survival free of dementia or disability.

Among the people 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. Rates of physical disability were similar, and rates of dementia were almost identical in both groups.