This August 23, 2018 file photo shows an arrangement of aspirin pills in New York. One large study found that low-dose and normal strength aspirin appeared to be equally safe and effective in preventing additional heart problems in people who already have heart disease. (AP Photo / Patrick Sison, File)
An unusual study in which thousands of heart disease patients enrolled and tracked their health online while taking low or normal strength aspirin concluded that both doses appear equally safe and effective in preventing additional heart problems and strokes.
But there is one major caveat: people had such a strong preference for the lower dose that it’s unclear whether the results can show that the treatments are really equivalent, some independent experts said. Half of those told to take the higher dose took the lower one instead or stopped using aspirin altogether.
“Patients basically made their own choices” what to take because they bought the aspirin themselves, said Dr. Salim Virani, a cardiologist at Baylor College of Medicine in Houston, who played no role in the study.
Still, the results show that there’s little reason to take the higher dose of 325 milligrams that many doctors have believed worked better than 81 milligrams of “baby aspirin,” he said.
The results were published Saturday by the New England Journal of Medicine and discussed at a conference held by the American College of Cardiology.
Aspirin helps prevent blood clots, but is not recommended for healthy people who have not yet developed heart disease because it poses a risk of bleeding. However, the benefits are obvious for people who have previously had a heart attack, bypass surgery, or clogged arteries in need of a stent.
However, the best dose is unknown, and the study aimed to compare them in a real-world setting. The study was funded by the Patient-Centered Outcomes Research Institute, established under the Patient Protection and Affordable Care Act 2010 to help patients make informed decisions about health care.
Approximately 15,000 people received invitations via email, email, or phone call and signed up on a website where they returned every three to six months for follow-up. A network of participating health centers provided medical information about the participants from their electronic records and insurance claims.
Participants were randomly selected to take low or regular dose aspirin that they bought over the counter. Almost all of them were taking aspirin before the study began, and 85% were already on a low dose. “Getting people to use the dose they were given was a difficult task from the start,” Virani said.
After about two years, about 7% of each group had died or had been hospitalized for a heart attack or stroke. The safety results were also similar – less than 1% had profuse bleeding that required hospitalization and a transfusion.
Nearly 41% of those tasked with the higher dose switched to the lower one at some point, and that high rate “might have masked a real difference” in safety or effectiveness, according to Colin Baigent, medical scientist at Oxford University in of Britain, wrote in a comment in the medical journal.
A study director, Dr. Schuyler Jones, of Duke University, said the study still provides valuable guidance. Now, if patients are taking low-dose aspirin, “the right choice is to keep that dose instead of switching,” he said. People who are now fine at 325 milligrams may want to move on and should speak to their doctors if they have any concerns.
For new patients, “we generally recommend starting on the low dose,” Jones said.
Virani said people need to remember that aspirin is a drug and that even though it is sold over the counter, patients should not make a decision about how to use it for themselves.
“Don’t change the dose or stop without talking to someone,” he warned. “This is especially important for a therapy like aspirin.”
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W. Schuyler Jones et al. Comparative Effectiveness of Aspirin Dosage in Cardiovascular Disease, New England Journal of Medicine (2021). DOI: 10.1056 / NEJMoa2102137
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