Heart disease kills more people than any other condition, but despite advances in treatment and prevention, patients often don’t stick to their medication regimens. Now, researchers may have found a solution: a drug called polypill that combines three drugs needed to prevent cardiovascular problems.
In the largest and longest-running randomized controlled trial of the approach, patients who were prescribed polypill within six months of a heart attack were more likely to continue taking the drug and significantly fewer cardiovascular eventscompared with those who received conventional drugs.
Participants also experienced less than a third of cardiovascular deaths, although their overall risk of death from all causes did not change significantly.
The study of more than 2,000 heart patients, followed for three years, was published Friday morning in the New England Journal of Medicine, as the results were presented at the European Society of Cardiology Congress in Barcelona.
The study is the culmination of 15 years of work by researchers led by Dr. Valentin Fuster, director of Mount Sinai Heart at Mount Sinai Hospital in New York City, and director general of the National Center for Cardiovascular Research. in Spain, comes first.
Dr. Thomas J. Wang, chair of internal medicine at UT Southwestern Medical Center, who was not involved in the study but wrote an editorial to accompany the study.
“It’s easier to take one pill than many, and it’s easier to take it once a day than several times a day.”
Dr. Wang added: “Under normal circumstances, doctors often under-prescribe drugs that should be prescribed.”
Polypill combines blood pressure medication, a cholesterol-lowering drug, and aspirin, which helps prevent blood clots. The idea was first put forward two decades ago in a more radical form: daily multi-votes for people when they turn 55says it will reduce cardiovascular events by 80% globally.
That notion was criticized and quickly relented. But the benefits of polypill for patients at risk for heart disease have been tested in numerous studies since then. Dr. Wang notes that polypills are already available to treat other medical conditions, such as HIV and hepatitis C.
The polypill used in the study has not been approved by the Food and Drug Administration and is not currently available to patients in the United States. Dr. Fuster said the results of the new trial will be submitted to the agency shortly for approval.
He called the results of the new study “remarkable” and said the benefit of the polyclonal drug in prevention was comparable to that of low-dose aspirin, now prescribed regularly for people who have had heart attacks or other conditions. other cardiovascular events.
And since participants were even more likely to continue taking the polypill over time, he said, “The potential outcomes could be even better with more follow-up.” Some studies have shown that only about half of patients, or even less, take all of their medications as directed.
The new study, a randomized controlled clinical trial, enrolled just under 2,500 patients at 113 sites in Spain, Italy, France, Germany, Poland, the Czech Republic and Hungary.
All enrollees had survived a heart attack within the previous six months. They are over 75 years old or at least 65 years old with other health conditions such as diabetes or kidney disease. Overall, about 80% have high blood pressure, nearly 60% have diabetes, and more than half have a history of smoking.
Almost all of the patients were white, and less than a third were women. Most are not high school graduates.
Half of the trial participants received the polypill, while the other half received normal care. There are several types of polypills and treatments are tailored to each patient.
All polyps contain 100 milligrams of aspirin, but doctors can choose between three doses of ramipril, a blood pressure medication, and between two doses of atorvastatin, a cholesterol-lowering drug.
The researchers found that adherence was higher among polypill users and increased over time. After six months, 70.6% of the polypill group adhered to their regimen, compared with 62.7% of those taking the usual medications.
At 24 months, about three-quarters of the patients were still taking the polypill, compared with 63.2% of the patients taking the usual medication.
Over three years, 12.7% of patients taking multiple of these drugs experienced another heart attack or stroke, or died of a cardiac event or needed urgent treatment to open a blocked artery, compared with 9.5% of patients take polypill, for a relative. 24 percent risk reduction.
However, there was no difference between the two groups in overall mortality, as the reduction in cardiovascular mortality in the polyclonal group was offset by death from other causes.
When asked why polypill is effective and why adherence is so poor, Dr. Fuster said, “People forget when there are some pills to take, they don’t take them all or they don’t take them.”
Although most patients adhere to treatment immediately after a heart attack, adherence declines after the first few months, he said.
Polypill can be less expensive to manufacture and distribute than a range of different pills. This finding could make cardiovascular preventive therapy more accessible, especially for individuals in low- and middle-income countries.
Although the patient population in the European study was very homogeneous, other studies have looked at the use of polypill in underserved and minority populations.
Dr. Wang led a study of a polypill prescribed to prevent major cardiovascular disease in a group of low-income, black adults in Alabama. Compliance is very high, and participants saw greater reductions in cholesterol and blood pressure compared to those who received the drug in their usual form.
A review of eight studies including more than 25,000 patients, also led by Dr. Wang, found that adherence to a drug regimen was significantly improved and significantly reduced cardiovascular risk factors.
Overall mortality was reduced in patients indicated for polypills, as well as in serious cardiac events, especially in those at low baseline risk and no prior heart disease.
