Daily Aspirin Benefits Called Into Question

Aspirin use in healthy older adults did not prolong disability-free survival and led to a higher rate of major hemorrhage than observed in those given placebo, according to the results of a recent clinical trial.

The ASPirin in Reducing Events in the Elderly (ASPREE) trial is an international, randomized, double-blind, placebo-controlled trial involving 19.114 older adults (16,703 in Australia and 2411 in the US), aged 70 years and older, who did not have dementia or physical disability at baseline. The purpose of the study is to investigate the effects of daily aspirin use (100 mg) on outcomes among healthy, community-dwelling older adults. The primary endpoints were death, dementia, and persistent physical disability. Secondary endpoints included fatal and nonfatal cardiovascular disease, fatal and nonfatal cancer, mild cognitive impairment, depression, and major hemorrhage.

Overall, the researchers observed no effect on survival free of dementia or disability among the initials taking 100 mg of aspirin daily. Of those taking aspirin, 90.3% remained alive and without persistent disability or dementia at the end of follow-up, compared with 90.5% of those taking placebo. Rates of dementia and physical disability were similar among the groups.

However, the researchers observed an increased risk of death in the aspirin group compared with the placebo group (5.9% vs 5.2%, respectively). This was due primarily to a higher rate of cancer deaths among the aspirin group.

“Other primary prevention trials of aspirin have not identified similar results, which suggests that the mortality results reported here should be interpreted with caution,” the researchers warned.

Rates of cardiovascular events were also shown to be similar between the aspirin and placebo groups (448 vs 474, respectively).

However, aspirin use was shown to be associated with a significantly higher risk of bleeding, primarily gastrointestinal and brain bleeds. These occurred in 3.8% of patients taking aspirin and 2.7% of those given placebo.

“In conclusion, these results of the ASPREE trial indicate that, over a median follow-up of 4.7 years, the use of low-dose aspirin in persons 70 years of age or older who did not have cardiovascular disease did not prolong disability-free survival in a predominantly white population.”

—Michael Potts

References:

McNeil JJ, Wolfe R, Woods RL, et al. effect of aspirin on cardiovascular events and bleeding in the healthy elderly [published online September 16, 2018]. NEJM. DOI: 10.1056/NEJMoa1805819

McNeil JJ, Woods RL, Nelson MR, et al. Effect of aspirin on disability-free survival in the healthy elderly [published online September 16, 2018]. NEJM. DOI: 10.1056/NEJMoa1800722.

McNeil JJ, Woods RL, Nelson MR, et al. Effect of Aspirin on All-Cause Mortality in the Healthy Elderly [published online September 16, 2018]. NEJM. DOI: 10.1056/NEJMoa1803955.