A daily regimen of low-dose aspirin may be more harmful than helpful in otherwise healthy elderly adults, according to a study published Sunday in the New England Journal of Medicine.
It's common medical practice for patients who have suffered from a heart attack or stroke to take aspirin to prevent a second occurrence, Reuters reports. But a team of U.S. and Australian researchers wanted to examine whether low-dose aspirin can prevent an initial heart attack, stroke, or case of heart failure among elderly adults.
For the study, the researchers from March 2010 through December 2014 examined the effects of low-dose aspirin therapy among 19,114 adults in Australia and the United States. The researchers largely focused on adults who were at least 70 years old and who did not have cardiovascular disease, dementia, or disability at the time of the study. The researchers accepted participants as young as 65 years old, however, if they identified as black or Hispanic—two groups with a higher risk of heart disease or dementia.
Of the participants, 9,525 received 100 milligrams of enteric-coated aspirin, and 9,589 received a placebo.
After about five years of treatment, the researchers found participants who received the low-dose aspirin did not have heart disease rates significantly lower than participants who took the placebo.
However, the researchers found participants who received aspirin had a higher risk of death from any cause than the participants who received the placebo. Specifically, researchers found the risk of death was:
- 12.7 events per 1,000 person-years among those who took aspirin; and
- 11.1 events per 1,000 person-years among those who took the placebo.
Overall, the researchers found 21.5 cases of death, dementia, or disability per 1,000 patients each year among those who took aspirin. In contrast, the researchers found 21.2 cases of death, dementia, or disability per 1,000 patients each year among those who took the placebo.
According to the researchers, 1,052 participants died during the trial. The researchers found, "Cancer was the major contributor to the higher mortality in the aspirin group, accounting for 1.6 excess deaths per 1,000 person-years." In particular, the researchers found cancer-related deaths occurred among 3.1% of participants who took aspirin, compared to 2.3% of study participants who took the placebo. The researchers "this result was unexpected and should be interpreted with caution" because previous research has shown aspirin can protect against cancer-related deaths.
In addition, the researchers found the chances of major hemorrhaging were 38% higher among the participants who took aspirin when compared with those who took the placebo. In particular, the researchers found the rate of major hemorrhaging was 3.8% among those who received aspirin, compared with 2.8% of those who received the placebo. The researchers also found intestinal bleeding and strokes occurred in 8.6% of participants who took aspirin, while such adverse events occurred in 6.2% participants who took the placebo.
Further, the researchers found participants with high blood pressure and high cholesterol who might take other medications to lower their high risks of heart attack or stroke did not seem to benefit from low-dose aspirin.
John McNeil of Monash University in Melbourne, who was an author of the study, said the study "provided convincing evidence that aspirin is ineffective in preserving good health in elderly people without a medical (reason) to be using it." McNeil added, "Essentially, we could not identify any subgroup in whom aspirin was beneficial in preserving good health."
Vincent Bufalino of the Advocate Heart Institute in Chicago, who was not involved in the study, said, "This should set the record straight. There's a lot of folks on both sides of this but this study should end the question. There is no benefit for seniors who do not have vascular disease."
Bufalino added, "If you look at the new findings, at best it's neutral and at worst it increases the bleeding risk" (Emery, Reuters, 9/16; Bernstein, Washington Post, 9/16; Stein, "Shots," NPR, 9/16; Krumholz, Forbes, 9/17; McNeil et. al, New England Journal of Medicine, 9/16).
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