Heart disease kills more people than any other condition, but despite advances in treatment and prevention, patients often do not stick to their medication regimens. Now researchers may have found a solution: a so-called polypill that combines three drugs needed to prevent cardiovascular trouble.
In what is apparently the largest and longest randomized controlled trial of this approach, patients who were prescribed a polypill within six months of a heart attack were more likely to keep taking their drugs and had significantly fewer cardiovascular events, compared with those receiving the usual assortment of pills.
The participants also experienced one-third fewer cardiovascular deaths, although their overall risk of death from all causes was not significantly changed.
The study of more than 2,000 heart patients, who were followed for three years, was published Friday morning in The New England Journal of Medicine, as the findings were presented at the European Society of Cardiology Congress in Barcelona, Spain.
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 general director of the National Center for Cardiovascular Research in Spain.
"Combination pills are easier for the physician and for the patient, and the data are pretty clear — it translates into a benefit," said Dr. Thomas J. Wang, chair 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.
The polypill combines a blood-pressure medication, a cholesterol-lowering drug and aspirin, which helps prevent blood clots.
The polypill used in the study has not been approved by the Food and Drug Administration and is not available to patients in the United States right now. Fuster said the results of the new trial would be submitted to the agency shortly in an effort to obtain approval.
And since participants became even more likely to keep taking the polypill over time, he said, "The potential results could be even better with more follow-up." Several studies have shown that only about half of patients, or even less, take all their medications as instructed.
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.