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 The trial has "provided convincing evidence that aspirin is
ineffective in preserving good health in elderly people without a
medical (reason) to be using it," chief author Dr. John J. McNeil of
Monash University in Melbourne told Reuters Health in an email.
The results - which show that risks of major bleeding in low-dose
aspirin users overwhelm any heart benefits - were reported online in
the New England Journal of Medicine and presented Sunday at the
European Respiratory Society International Congress in Paris.
The findings may upend a common practice.
For people trying to prevent a second heart attack or stroke,
evidence in support of baby aspirin therapy remains strong. But the
new study, known as ASPREE, looked at the long-standing question of
whether a first heart attack, stroke, or case of heart failure could
be prevented with small amounts of the blood thinner in aspirin.
Until now, the balance between risks and benefits in older
individuals was unclear, said Dr. McNeil.
Most volunteers had to be at least 70 years old. Patients who were
black or Hispanic and living in the U.S. - two groups that face a
higher risk of heart disease or dementia - could be age 65 or older.
At the start of the study, all were expected to survive for at least
five years.
After about five years of treatment, the rate of heart disease was
not significantly lower in the 9,525 volunteers taking 100 mg of
aspirin daily than in the 9,589 who took placebo tablets.
But the odds of a major bleeding episode were 38 percent higher with
aspirin. Problems like stroke and intestinal bleeding occurred in
8.6 percent of aspirin patients versus 6.2 percent of placebo
patients.
"This should set the record straight," said Dr. Vincent Bufalino of
the Advocate Heart Institute in Chicago, who was not involved in the
study. "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."
"I've spent the last five, six years trying to get all my seniors to
stop taking aspirin" based on the clear risks and unproven benefit,
he told Reuters Health by phone. "If you look at the new findings,
at best it's neutral and at worst it increases the bleeding risk."
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And what about people with high blood pressure or high cholesterol
who might be taking other medicines to mitigate a higher risk of
heart attack or stroke? In the new study, most volunteers fell into
that category and aspirin didn't seem to help them.
"Essentially, we could not identify any subgroup in whom aspirin was
beneficial in preserving good health," Dr. McNeil said.
The ASPREE study was stopped early as it became clear that the
"wonder drug" wasn't working wonders.
While there were 21.5 cases of death, dementia or disability per
1,000 patients each year in the aspirin group, the rate was 21.2
with placebo. The difference wasn't statistically significant,
meaning it could have been due to chance.
But the rate of major bleeding with daily aspirin use was 3.8
percent, versus 2.8 percent with placebo.
When the McNeil team looked at death from any cause, aspirin still
made no difference statistically, with a rate of 12.7 per 1,000
patients each year with aspirin and 11.1 with placebo.
Extra cases of cancer were the chief reason for the higher death
rate, with 3.1 percent of aspirin users dying of cancer versus 2.3
percent in the control group.
The higher pace of cancer deaths became apparent three and a half
years after the study began, particularly death from stomach and
intestinal tumors.
The cancer finding surprised researchers because in other studies,
aspirin protected against death from cancer.
Thus, McNeil team said, the cancer results "should be interpreted
with caution."
The study was coordinated at 34 sites in the U.S. and 16 in
Australia.
SOURCES: https://bit.ly/2paVqCb, https://bit.ly/2pdTLvA and https://bit.ly/2D3pMQR
The New England Journal of Medicine, online September 16, 2018.
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