Minneapolis, MN—Many healthy older adults who pop a low-dose aspirin every day might be medicating themselves unnecessarily.

That’s according to results of a large clinical trial published in the New England Journal of Medicine.

A study team led by researchers from Hennepin Healthcare in Minnesota and Australia’s Monash University found that daily aspiring does not extend healthy independent life in those patients, having little or no effect on the risk of dementia or persistent physical disability.

The ASPirin in Reducing Events in the Elderly (ASPREE) trial, which was partially supported by the National Institutes of Health, adds, however, that the effect on risks related to causes such as cancer or cardiovascular disease were not clear and will require further analysis.

Enrolled in ASPREE, an international, randomized, double-blind, placebo-controlled trial, were 19,114 older adults—16,703 in Australia and 2,411 in the United States. The minimum age of participation was age 65 years for African-Americans and Hispanics in the United States, because of their higher risk for dementia and cardiovascular (CV) diseases, and age 70 years for other participants.

At study enrollment in 2010, ASPREE participants, who were followed for an average of 4.7 years, could not have dementia or a physical disability and had to be free of medical conditions requiring aspirin use.

“Clinical guidelines note the benefits of aspirin for preventing heart attacks and strokes in persons with vascular conditions such as coronary artery disease,” said Richard J. Hodes, MD, director of the U.S. National Institute of Aging. “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.”

Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo.

With 1,052 deaths occurring during the follow-up period, the risk of death from any cause was 12.7 events per 1,000 person-years in the aspirin group and 11.1 events per 1,000 person-years in the placebo group (hazard ratio, 1.14; 95% confidence interval [CI], 1.01-1.29).

The researchers report that cancer was an outsized contributor to the higher mortality rate in the aspirin group, accounting for 1.6 excess deaths per 1,000 person-years. Overall, they said, cancer-related deaths occurred in 3.1% of the participants in the aspirin group and in 2.3% of those in the placebo group, for a hazard ratio of 1.31, (95% CI, 1.10-1.56).

“Higher all-cause mortality was observed among apparently healthy older adults who received daily aspirin than among those who received placebo and was attributed primarily to cancer-related death,” the authors conclude. “In the context of previous studies, this result was unexpected and should be interpreted with caution.”

The slightly higher death rate in patients using aspirin “has not been noted in previous studies; and caution is needed in interpreting this finding,” the study team adds. “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 report notes that its results do not apply to patients with a proven indication for aspirin such as stroke, heart attack or other cardiovascular disease, nor to those younger than age 65 years. The authors also emphasize that no one should stop using daily aspirin without consulting with a medical professional.

 « Click here to return to Weekly News Update.