How to Get Heart Patients to Take Their Pills? Give Them Just One.

Heart disease kills more people than any other disease, but despite advances in treatment and prevention, patients often do not stick to their medication. Now researchers may have found a solution: a so-called polypill, which combines three drugs needed to prevent cardiovascular disease.

In what appears to be the largest and longest randomized controlled trial of this approach, patients prescribed a polypill within six months of a heart attack were more likely to continue taking their medication and have significantly fewer cardiovascular events than patients who received the usual assortment of pills.

Participants also experienced a third fewer cardiovascular deaths, although their overall risk of death from all causes did not change significantly.

The study, which involved more than two thousand heart patients followed for three years, was published in the New England Journal of Medicine on Friday morning as the results were presented at the European Society of Cardiology Congress in Barcelona.

The study is the result of 15 years of work by researchers led by Dr. Valentin Fuster, Director of the Mount Sinai Heart at Mount Sinai Hospital in New York City and Director General of the National Center for Cardiovascular Research in Spain.

“Combination pills are easier for the doctor and for the patient, and the data is pretty clear — there is a benefit,” said Dr. Thomas J. Wang, chairman of the department of internal medicine at UT Southwestern Medical Center, who was not involved in the research but wrote an editorial accompanying the study.

“It’s easier to take one pill than multiple pills, and it’s easier to take it once a day than multiple times a day.”

The availability of a polypill also appears to be encouraging physicians to write prescriptions more in line with practice guidelines, added Dr. Wang added, “Under normal circumstances, doctors often prescribe too few drugs that should be given.”

The polypill combines a blood pressure medication, a cholesterol-lowering drug, and aspirin, which helps prevent blood clots. The idea was first floated two decades ago in a more radical form: proponents suggested giving everyone over the age of 55 a polypill a day, saying it would reduce cardiovascular events worldwide by 80 percent.

This idea was sharply criticized and quickly put to rest. But the benefits of a polypill for patients at risk for heart problems have since been tested in numerous studies. Polypills are already available to treat other conditions, such as HIV and hepatitis C, noted Dr. Wang tight.

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 study would be submitted to the agency shortly for approval.

Calling the results of the new study “striking,” he said the polypill’s prevention benefit rivals that of low-dose aspirin, which is now routinely prescribed to people who have already had a heart attack or other cardiovascular event.

And since the likelihood of participants continuing to take the polypill increased even further over time, he said, “The potential outcomes could be even better with more follow-up.” Several studies have shown that only about half of the Patients, or even less, take all of their medications as directed.

The new study, a randomized controlled clinical trial, enrolled nearly 2,500 patients at 113 sites in Spain, Italy, France, Germany, Poland, the Czech Republic and Hungary.

All participants had survived a heart attack within the previous six months. They were either older than 75 or at least 65 years old and had other health problems such as diabetes or kidney disease. Overall, about 80 percent had high blood pressure, nearly 60 percent had diabetes, and more than half had a history of smoking.

Almost all patients were white and less than a third were women. The vast majority were not high school graduates.

Half of the study participants received the polypill, while the other half received usual treatment. There were different types of polypills and treatment was tailored to individual patients.

All polypills contained 100 milligrams of aspirin, but doctors could choose between three doses of ramipril, a blood pressure medication, and two doses of atorvastatin, a cholesterol-lowering drug.

Medication adherence was higher among polypill users and increased over time, the researchers found. After six months, 70.6 percent of the polypill group were sticking to their diet plans, compared to 62.7 percent of those taking the usual pill choice.

At 24 months, about three-quarters of patients were still taking a polypill, compared with 63.2 percent of patients taking the usual pills.

Over a three-year period, 12.7 percent of patients who took a series of pills suffered another heart attack or stroke, or died from a cardiac event, or needed urgent treatment to open a blocked artery, compared with 9.5 percent of patients who took a polypill for a relative reduced risk by 24 percent.

However, there was no difference between the two groups in all-cause mortality, as the reduction in cardiovascular deaths in the polypille group was offset by deaths from other causes.

When asked why the polypill was effective and why the medication response was so poor, Dr. Fuster: “People forget when a series of pills have to be taken, they don’t take all of them or none at all.”

Although most patients adhere to treatment immediately after a heart attack, adherence wears off after the first few months, he said.

The polypill can be cheaper to manufacture and distribute than a variety of different pills. Findings could help make cardiovascular preventive therapy more accessible, particularly for people in low- and middle-income countries.

Although the patient cohort in the European study was very homogeneous, other studies have examined the use of polypills in minority and underserved populations.

dr Wang led a study of a polypill prescribed for the primary prevention of cardiovascular disease among a low-income, mostly black, group of adults in Alabama. Adherence was very high, and participants saw greater reductions in cholesterol and blood pressure than those who received medication in its usual form.

A review of eight studies involving over 25,000 patients, also conducted by Dr. Wang, revealed significantly improved adherence to medication with a polypill and a significant reduction in cardiovascular risk factors.

All-cause mortality fell in patients assigned to take polypills, as did serious cardiac events, particularly in those who were initially low-risk and had no prior heart disease.