Baby-aspirin may outweigh benefits in healthy older adults

The results can upset a common practice.

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According to a US-Australian study of more than 19,000 volunteers, the widespread practice of taking a baby aspirin every day can do more harm than good to healthy seniors who have never had a heart attack .

The trial has "provided compelling evidence that aspirin is ineffective for preserving health in the elderly without recourse to a medical reason," said in an email the lead author, Dr. John J. McNeil of Monash University in Melbourne.

The findings – which show that the risks of major hemorrhage in low-dose aspirin users exceed all cardiac benefits – were reported online in the New England Journal of Medicine and presented Sunday at the International Congress of Physiotherapy. the European Respiratory Society in Paris.

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The results can upset a common practice.

For people trying to prevent a second heart attack or second stroke, the evidence supporting aspirin treatment in the baby remains strong. But the new study, known as ASPREE, focused on whether a first heart attack, stroke, or heart failure could be prevented with small amounts of anticoagulant in aspirin. .

Until now, the balance between risks and benefits in the elderly has not been clear, said Dr. McNeil.

Most volunteers had to be at least 70 years old. Black or Hispanic patients living in the United States – two groups at higher risk for heart disease or dementia – may be 65 years of age or older. At the beginning of the study, all had to survive for at least five years.

After approximately five years of treatment, the rate of heart disease was not significantly lower among the 9,525 volunteers taking 100 mg of aspirin daily than among the 9,589 patients taking placebo.

But the probability of a major bleeding episode was 38% higher with aspirin. Problems such as stroke and intestinal bleeding occurred in 8.6% of patients on aspirin, compared to 6.2% of patients on placebo.

"This should set the record straight," said Dr. Vincent Bufalino of the Advocate Heart Institute in Chicago, who did not participate in the study. "There are a lot of people on both sides, but this study should end the question. There is no benefit for the elderly who do not have vascular disease.

"I have spent the last five or six years trying to get all my seniors to stop taking aspirin," he told Reuters Health by phone. "If you look at the new results, at best, they are neutral and, at worst, they increase the risk of bleeding."

And what about people with high blood pressure or high cholesterol who might be taking other medications to lessen a higher risk of heart attack or stroke? In the new study, most volunteers fell into this category and aspirin did not seem to help them.

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"Essentially, we could not identify any subgroup in which aspirin was beneficial to maintain good health," said Dr. McNeil.

The ASPREE study was stopped early because it became clear that the "miracle drug" was not working wonders.

While there were 21.5 cases of death, dementia, or disability for every 1,000 patients in the aspirin group each year, the rate was 21.2 with placebo. The difference was not statistically significant, that is, it could have been due to chance.

But the major haemorrhage rate with daily use of aspirin was 3.8%, compared with 2.8% with placebo.

When the McNeil team examined death for any cause, aspirin still did not make statistical difference, with a rate of 12.7 per 1,000 patients each year with aspirin and 11.1 with a placebo.

Additional cases of cancer were the main reason for the higher mortality rate, with 3.1% of aspirin users having died of cancer, compared to 2.3% in the control group.

The higher rate of cancer deaths became apparent three-and-a-half years after the start of the study, particularly in deaths from tumors of the stomach and intestine.

The discovery of cancer surprised researchers because in other studies, aspirin was protected against death by cancer.

Thus, according to the McNeil team, cancer outcomes "should be interpreted with caution."

The study was coordinated on 34 sites in the United States and 16 in Australia.