In a 19,114-person trial supported by the National Institutes of Health, researchers found that daily low-dose aspirin did not prolong independent living in healthy older adults.
Initial findings from the Aspree trial, which began in 2010, were published in The New England Journal of Medicine this week. The study involved participants who did not have dementia or a physical disability. Researchers followed the study’s participants for an average of 4.7 years to measure outcomes.
“Clinical guidelines note the benefits of aspirin for preventing heart attacks and strokes in persons with vascular conditions such as coronary artery disease,” Dr. Richard Hodes, director of the National Institute on Aging, said in prepared remarks. “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 NIH noted that while Bayer supplied aspirin and a placebo for the study, the pharmaceutical company was not otherwise involved.
Researchers highlighted an array of findings in their report. Daily treatment with 100 milligrams of low-dose aspirin did not impact survival free of dementia or disability, according to the study. In the group randomly assigned to take aspirin, 90.3% remained alive at the end of the treatment without physical disability or dementia, compared to 90.5% in the placebo group.
The researchers noted that rates of physical disability and dementia were nearly identical between the two groups, as well as the rates for major cardiovascular events including coronary heart disease and ischemic stroke.
Study investigators also pointed out that aspirin was linked with a significantly higher risk of bleeding in the gastrointestinal tract and brain compared to the placebo.
“Continuing follow-up of the Aspree participants is crucial, particularly since longer term effects on risks for outcomes such as cancer and dementia may differ from those during the study to date,” Dr. Evan Hadley, director of NIA’s geriatrics & clinical gerontology division, added. “These initial findings will help to clarify the role of aspirin in disease prevention for older adults, but much more needs to be learned. The Aspree team is continuing to analyze the results of this study and has implemented plans for monitoring participants.”
The team of researchers plan to further analyze data from the study, including data showing an increase in cancer deaths among the participants using aspirin.
“The increase in cancer deaths in study participants in the aspirin group was surprising, given prior studies suggesting aspirin use improved cancer outcomes,” Dr. Leslie Ford, associate director for clinical research at the National Cancer Institute’s division of cancer prevention, explained. “Analysis of all the cancer-related data from the trial is under way and until we have additional data, these findings should be interpreted with caution.”