ASCEND: No effect of long-term, low-dose aspirin on dementia risk in adults with diabetes
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Daily low-dose aspirin use over 7 years did not affect the risk for incident dementia or cognitive decline in U.K. adults with type 2 diabetes, according to new data from the ASCEND trial.
Jane Armitage, FRCP, professor of clinical trials and epidemiology at the Nuffield Department of Population Health at the University of Oxford, U.K., and colleagues evaluated the effects of long-term aspirin use on development of dementia and cognitive impairment. Armitage presented results from 15,480 adults with type 2 diabetes and no history of CVD or dementia at baseline (mean age, 63 years; 63% men) who were randomized assigned to daily use of aspirin 100 mg or placebo. Mean follow-up was 7.4 years.
Key outcomes included two definitions of dementia: a broad dementia outcome that aimed to gather individuals who might have had dementia but were not diagnosed and a narrower definition of dementia diagnosis. At the end of the trial, researchers conducted cognitive function tests on survivors who were able to respond. The tests included either the Telephone Interview for Cognitive Status and verbal fluency or the Healthy Minds test.
Events were reported using electronic admission records as well as by patients, caretakers or their physicians.
The researchers found 1,146 patients had “broad dementia,” meaning dementia, cognitive impairment or delirium or confusion. These patients were prescribed dementia medications or received a referral to a memory clinic or general psychiatry, according to an AHA press release.
Incidence of components of the broad dementia outcome occurred in 7.1% of the aspirin group compared with 7.8% of the placebo group (RR = 0.91; 95% CI, 0.81-1.02). The difference was not significant, Armitage said. Further, Armitage said in the press release, “the uncertainty around this 9% benefit ranged from a 19% reduction in dementia to a 2% increase. This is reassuring that an increase in the risk of dementia is unlikely for the millions of people worldwide who regularly take aspirin to protect against the risk of heart attack and stroke.”
Incidence of the narrower dementia outcome was 3.3% in the aspirin group compared with 3.7% in the placebo group (HR = 0.89; 95% CI, 0.75-1.06). Again, this was not significant, Armitage said.
Results were similar for cognitive function.
There were 990 participants who survived a major vascular event and 496 who survived a major bleed during the study, according to the presentation. Major bleeding (RR = 1.96; 95% CI, 1.49-2.56) and serious vascular events such as MI, stroke and transient ischemic attacks were associated with a twofold or greater risk for future dementia (RR = 2.4; 95% CI, 1.97-2.92); however, revascularization did not appear to effect risk for future dementia (RR = 0.91; 95% CI, 0.68-1.23).
“ASCEND provides randomized evidence of the effects of low-dose aspirin on dementia and cognitive impairment based on 1,146 incident broad dementia events. No statistically significant effect on dementia outcomes were seen, but the results excluded proportional harms more than about 2% and benefits to more than 19%,” Armitage said during the press conference. “It is plausible that aspirin could have benefits of the order of 15% to 18%, but trials with larger numbers of incident dementia cases are needed to assess whether such benefits actually exist. In the U.K., using electronic health admission data, such as we've been able to, gives a cost-effective means of assessing the impact of vascular therapies on dementia.”
Perspective
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Edward T.A. Fry, MD, FACC
ASCEND is asking an important question at an important time. It is a difficult trial to do; as the investigators laid out, they tried to make it as objective as possible in terms of defining what is a dementia event, but there is still some subjectivity to it and there's a continuum. The researchers also excluded perhaps a significant group of patients in that people who have had a disabling stroke were excluded. People who had cognitive difficulties or dementia issues after disabling stroke were taken out of the mix, and that may have reduced some of the numbers in terms of prevention.
The signal that there may be some reduction in dementia and cognitive impairment with aspirin is there. In so many things we see with aspirin, there may be a benefit on the efficacy side, but there are also concerns related to bleeding. Perhaps the focus should be on better identification of patients who are at risk for bleeding, thereby focusing, perhaps, the greater amount of benefit to the right people. That's true with any application of aspirin.
It's going to come down to having a conversation with the patient and the patient's family and making individual choices. If a patient is at high risk for bleeding, the upside of aspirin may not be worth it. If they're at low risk for bleeding but high risk for dementia, the upside may be there.
Collapse
Armitage J, et al.LBS.07. New Drugs and New Drug Indications in Cardiovascular Disease. Presented at: American Heart Association Scientific Sessions; Nov. 13-15, 2021 (virtual meeting).
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