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Daily aspirin not only failed to help generally healthy older individuals reduce their risk of disability-free survival and cardiovascular disease in the placebo-controlled , it also appeared to raise overall mortality and particularly death from cancer.

The primary endpoint of combined death, dementia, persistent physical disability came up in equal rates among healthy seniors randomized to 100 mg daily enteric-coated aspirin or placebo for 5 years (21.5 versus 21.2 events per 1,000 person-years, HR 1.01, 95% CI 0.92-1.11), according to ASPREE investigators led by John J. McNeil, MD, of Monash University in Australia.

Major hemorrhages were found to be more common in the aspirin group (8.6 versus 6.2 per 1,000 person-years, HR 1.38, 95% CI 1.18-1.62). This counted the uptick in upper gastrointestinal bleeding (HR 1.87, 95% CI 1.32-2.66) and intracranial bleeds (HR 1.50, 95% CI 1.11-2.02).

Aspirin users also showed a higher risk of all-cause mortality (12.7 versus 11.1 per 1,000 person-years, HR 1.14, 95% CI 1.01-2.19), which was driven by cancer deaths (6.7 versus 5.1 per 1,000 person-years, HR 1.31, 95% CI 1.10-1.56).

"The trial was terminated at a median of 4.7 years of follow-up after a determination was made that there would be no benefit with continued aspirin use with regard to the primary end point," the authors noted in a report published online in the (one of three covering various aspects of the trial).

No individual component of the primary endpoint made a case for the benefit of aspirin, which failed to reduce the risk of cardiovascular disease as well (10.7 versus 11.3 events per 1,000 person-years, HR 0.95, 95% CI 0.83-1.08).

"Interpretation of these results should take into account the lower-than-expected rate of cardiovascular disease among the trial participants ... most likely reflecting the relatively good health of the participant population at recruitment and the declining rate of cardiovascular disease in the two countries over time and across all age groups," the investigators suggested.

Steven Nissen, MD, of Cleveland Clinic, told 番茄社区app that the main results of ASPREE are not surprising. "Many people, including me, do not believe that aspirin offers meaningful benefits in primary prevention and carries substantial bleeding risks ... Unless the cardiovascular risk is very high (>20% over ten years), prophylactic aspirin results in more harm than good."

The trial follows in the heels of other major studies offering mixed-to-negative data on aspirin for primary prevention, most recently ASCEND and ARRIVE in diabetes and moderate-risk patients, respectively (both were recently presented at the European Society of Cardiology meeting).

ASPREE was a 19,114-person study of low-dose aspirin conducted in Australia and the U.S.

McNeil and colleagues noted that adherence to the assigned treatment was 62.1% and 64.1% among aspirin and placebo recipients, respectively, during the final year of trial participation.

Participants had to be 70 years or older (or 65 and older among blacks and Hispanics in the U.S.). The trial cohort was a median age 74 years at the time of enrollment in 2010-2014; 56.4% were women and 91.3% were white.

The lack of racial diversity limits the generalizability of the trial, the authors said.