A three-in-one drug combo can help people with a history of heart attacks stay healthy, new research shows. The randomized clinical trial found that people who took the bundled medication, also known as a polypill, went on to experience fewer heart attacks, strokes, or cardiovascular-related deaths than those given standard care. The findings may pave the way for the polypill to become a common heart treatment moving forward.
The basic concept of the polypill has been around for over two decades. Many medical conditions require taking multiple medications, which can be a time-consuming task and added burden for patients. So by taking these individual drugs and putting them into a single pill, the theory goes, you can make it easier for patients to adhere to their treatment. There are already standard treatments for some conditions, such as HIV, that are given as a combination medication. But the original inspiration for the polypill was as a way to improve the treatment of cardiovascular disease. And now, this strategy seems to have passed its biggest test yet with flying colors.
In 2015, the “Secondary prevention of Cardiovascular disease in the Elderly”—or SECURE—trial began. It was meant to test out a fixed dose combination of three generic drugs already known to improve heart disease outcomes: aspirin, a common statin known as atorvastatin, and the ACE inhibitor ramipril. The combo drug is manufactured by the pharmaceutical company Ferrer and is approved in the EU and some other countries as Trinomia.
About 2,500 heart attack survivors over the age of 65 were included in the trial, which was sponsored by the EU and conducted in seven European countries. The patients were randomized to either receive Trinomia or standard treatment. They were then tracked over the next five years, with the researchers primarily looking for incidents of cardiovascular-related death, along with nonfatal heart attacks, strokes, and blocked coronary arteries that needed urgent treatment.
Ultimately, 12.7% of patients in the control group experienced at least one of these outcomes, compared to 9.5% of those in the polypill group, amounting to a 24% reduction in risk. When it came to deaths in particular, those who took the polypill were 33% less likely to die than control patients. And other data showed that people on the polypill were more likely to keep taking it as recommended—exactly as hoped. The study’s findings were published Friday in the New England Journal of Medicine.
“Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care,” the authors wrote.
The SECURE trial is the first of its kind to test the polypill for heart attack survivors. Many experts in the field have been waiting for the study’s findings to emerge, and it’s this sort of gold standard data that can lead to the wider acceptance of a novel treatment approach in medicine. Given these results, it’s likely that more countries will decide to approve Trinomia. (Notably, the US has not approved Trinomia, though it has approved other polypills.) So the drug may very well someday become a new standard of care for survivors at risk of future heart complications.
“The SECURE study findings suggest that the polypill could become an integral element of strategies to prevent recurrent cardiovascular events in patients who have had a heart attack. By simplifying treatment and improving adherence, this approach has the potential to reduce the risk of recurrent cardiovascular disease and death on a global scale,” said senior study author Valentin Fuster, the physician-in-chief at Mount Sinai Hospital in New York as well as the general director of the Spanish National Center for Cardiovascular Research, in a statement released by Mount Sinai.