Three-drug medication used to prevent recurrent cardiovascular events after a heart attack

Three-drug medication used to prevent recurrent cardiovascular events after a heart attack

A three-drug drug known as "Polypill," developed by Spain's National Center for Cardiovascular Research (CNIC) and Ferrer, is effective in preventing secondary adverse cardiovascular events in people who have previously had a heart attack, reducing cardiovascular mortality by 33 percent in this patient population. These are results of the SECURE study led by Valentin Fuster, MD, PhD, director of Mount Sinai Heart and chief medical officer of Mount Sinai Hospital and director general of CNIC.

The study results were announced in a hotline session at the European Society of Cardiology Congress (ESC 2022) in Barcelona, ​​Spain on Friday, August 26, and published in the New England Journal of Medicine.

The results of the SECURE study show that the polypill containing aspirin, ramipril and atorvastatin achieves, for the first time, clinically relevant reductions in recurrent cardiovascular events in people who have overcome a previous heart attack due to a better adherence to a simplified approach with a simple polypill, rather than using them separately as is traditionally the case to take.”

Dr. Valentin Fuster, MD, Ph.D., director of Mount Sinai Heart and physician-in-chief of Mount Sinai Hospital and director general of CNIC

Patients recovering from a heart attack - also known as a myocardial infarction - are prescribed special treatments to prevent subsequent cardiovascular events. Standard therapy includes three different medications: an antiplatelet drug (such as aspirin); ramipril or a similar medicine to control blood pressure; and a lipid-reducing drug, such as a statin. However, less than 50 percent of patients adhere consistently to their medication.

"Although most patients initially adhere to treatment after an acute event such as a heart attack, adherence declines after the first few months. Our goal was to achieve an effect from the start and most patients in the study started treatment with a simple polypill in the first week after a heart attack," explains Dr. Fuster.

“Adherence to treatment after an acute myocardial infarction is essential for effective secondary prevention,” said José María Castellano, MD, first author of the study and scientific director of the Fundación de Investigación HM Hospitales.

CNIC scientists first showed in the FOCUS study, previously published in the Journal of the American College of Cardiology (JACC), that prescribing their polypill significantly improved treatment adherence in patients recovering from a myocardial infarction.

The CNIC team launched the SECURE trial, an international randomized clinical trial to determine whether improved adherence with the polypill resulted in a reduction in cardiovascular events. The polypill analyzed in the study, sold under the name Trinomia, contains aspirin (100 mg), the angiotensin-converting enzyme inhibitor ramipril (2.5, 5 or 10 mg) and atorvastatin (20 or 40 mg).

“The polypill, as a very simple strategy that combines three essential treatments for this type of patient, has proven to be effective as the improved adherence means that these patients receive better treatment and therefore have a lower risk of recurrent cardiovascular events,” added Dr Castellano.

SECURE included 2,499 patients from seven European countries (Spain, Italy, Germany, Czech Republic, France, Poland and Hungary) recovering from a heart attack. Study participants were randomly assigned to standard therapy or the CNIC polypill. The average age of the participants was 76 years, 31 percent were women. The study population included 77.9 percent with hypertension, 57.4 percent with diabetes, and 51.3 percent with a history of tobacco smoking.

Researchers analyzed the incidence of four major cardiovascular events: death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, and the need for emergency coronary revascularization (restoring blood flow through a blocked coronary artery). The study followed patients for an average of three years and produced conclusive results: Patients taking the CNIC polypills had a 24 percent lower risk of these four events than patients taking the three separate medications.

The standout result of the study is the effect of the polypill on the key outcome of cardiovascular-related deaths, which showed a relative reduction of 33 percent from 71 patients in the standard treatment group to just 48 in the polypill group. Importantly, the study found that patients in the polypill group had higher adherence to treatment than those in the control group, confirming the results of the previous FOCUS study, and in part such good adherence seems to explain the benefits of the simple polypill.

"The 33 percent reduction in cardiovascular mortality demonstrates the effectiveness of treatment with Trinomia compared to standard treatment. These results confirm our goal to have a positive impact on society and represent an important step in our mission to provide significant and differentiated value to people suffering from serious health problems," explains Oscar Pérez, Chief Marketing, Market Access and Business Development Officer at Ferrer.

"The results of the SECURE trial suggest that the polypill could become an integral part of strategies to prevent recurrent cardiovascular events in patients who have suffered 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," adds Dr. Fuster added.

The SECURE study was funded by the European Union's Horizon 2020 research and innovation program (study identifier NCT02596126).

Source:

Mount Sinai Health System

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