Daily Low-Dose Aspirin Found to Have No Effect on Healthy Lifespan in Older Adults
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. At study enrollment, ASPREE participants could not have dementia or a 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.
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.
The group taking aspirin had an increased risk of death compared to the placebo group: 5.9% of participants taking aspirin and 5.2% taking placebo died during the study. This effect of aspirin has not been noted in previous studies, and caution is needed in interpreting this finding. The higher death rate in the aspirin-treated group was due primarily to a higher rate of cancer deaths. A small increase in new cancer cases was reported in the group taking aspirin but the difference could have been due to chance.
The researchers also analyzed the ASPREE results to determine whether cardiovascular events took place. They found 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 experienced cardiovascular events, compared with 474 people in the placebo group.
Significant bleeding was also measured. The investigators noted 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.
As would be expected in an older adult population, cancer was a common cause of death, and 50% of the people who died in the trial had some type of cancer. Heart disease and stroke accounted for 19% of the deaths and major bleeding for 5%.
Older adults should follow the advice from their own physicians about daily aspirin use. It is important to note the new findings do not apply to people with a proven indication for aspirin such as stroke, heart attack, or other cardiovascular disease. In addition, the study did not address aspirin’s effects in people younger than age 65. Also, since only 11% of participants had regularly taken low-dose aspirin prior to entering the study, the implications of ASPREE’s findings need further investigation to determine whether healthy older people who have been regularly using aspirin for disease prevention should continue or discontinue use.
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