A three-in-one drug combination could help people with a history of heart attacks stay healthy, new research show. The randomized clinical trial found that people who took the bundled medication, also known as a polypill, had fewer heart attacks, strokes or cardiovascular deaths than those who received standard care. The findings could pave the way for the polypill to become a common heart treatment in the future.
The basic concept of the polypil has been around for more than two decades. Many medical conditions require taking multiple medications, which can be a time-consuming task and additional burden for patients. So by taking these individual drugs and putting them in a single pill, the theory goes, you can make it easier for patients to stick to their treatment. There are already standard treatments for some conditions, such as HIV, that are given as combination medication. But the original inspiration for the polypill was 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 study “Secondary prevention of cardiovascular diseases in the elderly” or SECURE was conducted began. It aimed to test 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: Trinomy.
About 2,500 heart attack survivors over the age of 65 took part in the trial, which was sponsored by the EU and carried out in seven European countries. Patients were randomized to receive either Trinomia or standard of care. They were then followed over the next five years, with the researchers primarily looking for cases of cardiovascular death, along with non-fatal heart attacks, strokes, and blocked coronary arteries requiring 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, which equates to a risk reduction of 24%. When it came to deaths in particular, those taking the polypill were 33% less likely to die than control patients. And other data showed that people who took the polypill were more likely to continue taking it as recommended-exactly as hoped. The findings of the study were: published Friday in the New England Journal of Medicine.
“Treatment with a polypill containing aspirin, ramipril and atorvastatin within 6 months of myocardial infarction resulted in a significantly lower risk of major cardiovascular events than usual care,” the authors wrote.
The SECURE study 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, and it’s this kind of gold standard data that could lead to wider adoption of a new treatment approach in medicine. Given these results, it is likely that more countries will decide to adopt Trinomia. (The US in particular has not approved Trinomia, although it is approved other poly pills.) So the drug may one day very well become a new standard of care for survivors who are at risk for future heart complications.
“The findings of the SECURE study suggest that the polypill could become an integral part 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 chief physician of Mount Sinai Hospital in New York. as general manager of the Spanish National Center for Cardiovascular Research, in a statement issued by Mount Sinai.