A three-drug medication ‘polypill’ containing aspirin, ramipril, and atorvastatin is effective in preventing secondary adverse cardiovascular events in people who have previously had a heart attack, reducing cardiovascular mortality by 33% in this patient population.
The study results were published in The New England Journal of Medicine.
“The results of the SECURE study show that 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 because of better adherence to this simplified approach with a simple polypill, rather than taking them separately as conventional,” said Valentin Fuster, MD, PhD, who led the trial.
Standard therapy for patients recovering from myocardial infarction includes three different drugs: an antiplatelet agent (like aspirin); ramipril or a similar drug to control blood pressure; and a lipid-reducing drug, such as a statin. However, adherence is poor over 50% of patients not taking their medications.
“Although most patients initially adhere to treatment after an acute event such as an infarction, adherence drops off after the first few months. 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,” Dr Fuster explained.
“Adherence to treatment after an acute myocardial infarction is essential for effective secondary prevention,” said José María Castellano, MD, study first author.
Scientists at the Spanish National Center for Cardiovascular Research (CNIC) and Ferrer developed the polypill. It was first shown that prescription of their polypill significantly improved treatment adherence among patients recovering after a myocardial infarction, in the FOCUS study.
The CNIC team launched the SECURE study, an international randomised clinical trial, to determine whether the improved treatment adherence with the polypill translated into a reduction in cardiovascular events. The polypill analysed in the study, marketed as Trinomia, contains aspirin (100mg), the angiotensin-converting enzyme inhibitor ramipril (2.5, 5, or 10mg), and atorvastatin (20 or 40mg).
“The polypill, being a very simple strategy that combines three essential treatments for this type of patient, has proved its worth because the improved adherence means that these patients are receiving better treatment and therefore have a lower risk of recurrent cardiovascular events,” added Dr Castellano.
SECURE included 2499 patients from seven European countries recovering after a heart attack. Study participants (average age 76 years, 31% female) were randomised to receive standard therapy or the CNIC polypill. The study population included 77.9% with hypertension, 57.4% with diabetes, and 51.3% with a smoking history.
Researchers analysed the incidence of four major cardiovascular events: death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, and need for emergency coronary revascularisation. The study followed patients for an average of three years and produced conclusive results: patients taking the CNIC polypills had a 24% lower risk of these four events than patients taking the three separate drugs.
The standout finding of the study is the effect of the polypill on the key outcome of cardiovascular-related death, which showed a relative reduction of 33%, from 71 patients in the group receiving standard treatment to just 48 in the polypill group. Importantly, the study found that patients in the polypill group had a higher level of treatment adherence than those in the control group, in line with the earlier FOCUS study, and in part such good adherence appears to explain the benefits of the simple polypill.
“The 33% reduction in cardiovascular mortality demonstrates the efficacy of treatment with Trinomia compared to standard treatment. 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,” explains Oscar Pérez, Chief Marketing, Market Access and Business Development Officer at Ferrer.
“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,” added Dr Fuster.
Source: Mount Sinai
