‘Polypill’ Trinomia cuts heart disease deaths: study

One pill may be better than three.

A heart medication known as a “polypill” reduced the chance of a secondary adverse cardiovascular event in individuals who previously had a heart attack, according to the findings of a study announced on Friday, August 26, at the European Society of Cardiology Congress (ESC 2022) in Barcelona, Spain.

The cardiovascular mortality rate was lowered by 33%, the study found.  

Published in The New England Journal of Medicine, the study found that the drug, bearing the commercial name Trinomia, contains three medications: aspirin (100 mg), the angiotensin-converting enzyme inhibitor ramipril (2.5, 5, or 10 mg) and atorvastatin (20 or 40 mg), according to a news release.

The Spanish National Center for Cardiovascular Research (CNIC) and Ferrer developed the polypill.

Currently, the polypill is not available in the United States. 

Dr. Valentin Fuster, M.D., director of Mount Sinai Heart and physician-in-chief of Mount Sinai Hospital as well as general director of CNIC, led the trial.

The study’s results demonstrate “for the first time that the polypill — which contains aspirin, ramipril and atorvastatin — achieves clinically relevant reductions in the recurrent cardiovascular events among people who have recovered from a previous heart attack,” he said in the release.

That’s “because of better adherence to this simplified approach with a simple polypill, rather than taking [pills] separately as conventional,” he went on.

Typically, after a patient recovers from a heart attack, doctors prescribe several medications, which may include an anti-platelet agent (such as aspirin), medication to control blood pressure and a lipid-reducing drug, such as a statin, the release said. 

The problem is that less than half of patients consistently adhere to their medication regimen, according to the study’s authors. 

“Although most patients initially adhere to treatment after an acute event such as an infarction, adherence drops off after the first few months,” Dr. Fuster said in the release.

He also explained, “Our goal was to have an impact right from the start, and most of the patients in the study began taking a simple polypill in the first week after having a heart attack.”

The study’s first author, Dr. José María Castellano, M.D., said in the report, “Adherence to treatment after an acute myocardial infarction is essential for effective secondary prevention.” 

Castellano also said in the release, “The polypill, [which is] a very simple strategy that combines three essential treatments for this type of patient, has proved its worth … The improved adherence means that these patients are receiving better treatment and therefore have a lower risk of recurrent cardiovascular events.”

In a previous study that was published in the Journal of the American College of Cardiology (JACC), CNIC scientists showed that patients treated with the polypill showed significant improvement when it came to adhering to treatment. 

The CNIC team of researchers investigated if the improved adherence to treatment with the polypill would lead to a reduction in cardiovascular events. 

The study used an international randomized clinical trial that included 2,499 patients from seven European countries recovering from a heart attack. 

The participants were randomly assigned the CNIC polypill or standard treatment medications. Participants averaged 76 years of age — and the study included individuals with a history of hypertension (77.9%), diabetes (57.4%) and smoking tobacco (51.3%).

The team of researchers followed the patients for an average of three years.

They analyzed the occurrence of four major cardiovascular events: death from a cardiovascular cause, non-fatal stroke, non-fatal myocardial infarction and need for emergency coronary revascularization, the report said. 

They found that the patients taking the polypills had a 24% lower risk of these four cardiovascular events than patients taking the three drugs separately, according to the release.

The researchers found that there were 71 deaths in the group that received standard treatment, compared to 48 in the polypill group.  

Patients in the polypill group also had a higher level of treatment adherence than those in the control group — which may explain the benefits of the polypill, the release said.

“The 33% reduction in cardiovascular mortality demonstrates the efficacy of treatment with Trinomia compared to standard treatment” Oscar Pérez, marketing chief and business development officer at Ferrer, said in the release. 

The treatment has the “potential to reduce the risk of recurrent cardiovascular disease and death on a global scale.”

“These results ratify our purpose of making a positive impact in society and represent an important step in our mission to provide significant and differential value to people who suffer from serious health conditions.” 

The polypill could become part of a worldwide treatment strategy, said Fuster, to help prevent recurrent cardiovascular events in patients who have had a heart attack.

Fuster also said, “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.”

A Mount Sinai Health Systems spokesperson told Fox News Digital that Fuster plans to present the findings to the US Food and Drug Administration (FDA).