A single pill combining three heart drugs significantly reduced heart-related deaths and other heart problems in people who had previously had heart attacks, according to new research published Friday in the New England Journal of Medicine.
The results of the “multi-pill” were so compelling — a 24 percent reduction in deaths related to heart disease or further heart problems — that the researchers plan to submit the data to the Food and Drug Administration for approval, said the study’s lead author, Dr. Valentin Fuster, director of Mount Sinai Heart and chief medical officer of Mount Sinai Hospital in New York.
“The results were, frankly, very exciting,” said Fuster, who presented the findings Friday at a meeting of the European Society of Cardiology in Barcelona, Spain.
The idea of a polypill to treat heart disease is not new. researchers have been toying with the idea for two decades. A separate study published in 2020 found that a polypill combining four drugs reduced the risk of first heart attacks and strokes in people who were at risk for such problems.
Dr. Salim Yusuf, the lead author of the 2020 study and a cardiologist and professor of medicine at McMaster University in Ontario, said the new research confirms that a multi-pill would provide “substantial” benefits.
“The evidence is now overwhelming,” he said.
FDA committees have met in the past to discuss the potential risks and benefits of other versions of a polypill, but none have been approved in the US.
In the U.S., however, clinical trials of polypills have not been large enough to show that the drug had a real-world benefit, Dr. Thomas Wang, a cardiologist at UT Southwestern Medical Center in Dallas, wrote in an article accompanying the new study. .
Another challenge was determining the right combination of drugs at the right doses for a pill that could be widely prescribed.
The apparent one-size-fits-all approach has been a sticking point for some doctors. Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, said providers should be able to individualize doses of such drugs for each patient.
Still, Nissen, who was not involved in the research, said he was intrigued by the results. “The polypill shows promising results in this trial, although it would be helpful to have a larger, confirmatory trial,” he said.
Fuster said he and his team went through 50 variations of such a pill to come up with the right recipe that would provide benefits.
They ended up using three drugs: a statin to lower cholesterol, an ACE inhibitor to lower blood pressure, and aspirin, which makes blood less likely to clot. All three drugs are available in generic forms and are therefore expected to keep costs low.
But it may not be the combination of drugs in the polypill that ultimately led to improvements. It could simply be that people were more likely to take their medication if they only had one pill instead of several.
People discharged from the hospital after heart attacks are usually sent home with four to five prescriptions to prevent second heart attacks, said Dr. Donald Lloyd-Jones, a cardiologist who is the immediate past president of the American Heart Association.
“It’s a lot to ask of people, to keep track of five medications,” he said, especially for older patients who may need extra support managing their prescriptions.
It’s not uncommon for people to initially take their prescribed heart medications after a heart attack, but become less diligent over time.
“It’s a natural human instinct that as you get further from that event, there’s a sense that somehow they’re at less risk and they stop taking one or more of their medications,” said Dr. Greg Fonarow, interim chief of cardiology at UCLA Health in Los Angeles.
Combining the drugs into a single pill reduces the chance of a person missing out on potentially life-saving drugs. In fact, that was the main driver of the new study’s results: People who were prescribed the polypill were more likely to take it.
“Compliance was the single most important factor,” Fuster said. “It actually drove the results.”
Fuster’s study included 2,499 patients over the age of 65 who had previously had a heart attack.
All patients were given the same three drugs, but half were given them in a single pill, while the others were prescribed the drugs as usual, as separate pills.
Over the next three years, 12.7% of those in the usual care group had heart attacks or strokes, or needed procedures such as bypass to restore blood flow to blocked veins and arteries, or died because of their heart disease, in compared to 9.5% of them. given the polypill.
Adverse events were similar in both groups.
Fonarow, who was not involved in the new study, called the data “remarkable.”
The benefits of the multi-pill were clear, he said: The single pill made people more likely to take their prescribed doses, and that led to a lower risk of future heart problems.
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