People who have survived a myocardial infarction must follow a treatment to prevent a new heart attack that includes three different drugs: an antiplatelet agent (such as aspirin); more ramipril or a similar drug to control blood pressure; and a drug that lowers cholesterol levels, such as a statin. The problem is that adherence to this type of treatment is less than 50%. For this reason, it is much easier for these patients to comply with their therapeutic regimen with a polypill – marketed under the name Trinomia – that includes the three types of medication they need: aspirin, an ACE inhibitor (angiotensin converting enzyme ) and a statin.
Now, the new SECURE study, presented at the Congress of the European Society of Cardiology (ESC 2022) held these days in Barcelona, has shown that this polypill, developed by the Carlos III National Cardiovascular Research Center (CNIC) and Ferrer, reduces a 33% cardiovascular mortality in people who have previously suffered a heart attack, and also reduces the risk of experiencing serious cardiovascular events by 24%. The SECURE study has been led by Dr. Valentín Fuster, director of Mount Sinai Heart and chief physician of The Mount Sinai Hospital, and general director of the CNIC, and has been published in The New England Journal of Medicine.
“The results of the SECURE study show that for the first time the polypill, which contains aspirin, ramipril and atorvastatin, achieves clinically relevant reductions in recurrent cardiovascular events among people who have recovered from a previous heart attack due to better adherence to them. . this simplified approach with a simple polypill, instead of taking them separately as is conventionally done,” said Dr. Fuster.
“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 have an impact from the beginning, and most of the patients in the study started taking a simple polypill in the first week after suffering a heart attack”, explains Dr. Fuster. “Adherence to treatment after an acute myocardial infarction is essential for effective secondary prevention,” adds Dr. José María Castellano, first author of the study and scientific director of the HM Hospitales Research Foundation.
A ‘three-in-one’ drug after overcoming a heart attack
Myocardial infarction occurs when an artery in the heart becomes blocked because a thrombus has formed. Substances such as cholesterol that form plaques – atherosclerosis – can accumulate on the walls of the arteries and, when broken, mix with the blood and form clots that prevent proper blood circulation to the heart.
That is the reason why patients who have overcome a heart attack are usually prescribed antiplatelet drugs such as aspirin, which prevent the formation of new thrombi. But, in addition, they also add a statin to control cholesterol levels and, in some cases, a drug to prevent high blood pressure. This would make a minimum of three pills, which are sometimes more depending on the patient’s previous illnesses and the severity of the heart attack.
“The polypill could become an integral element of strategies to prevent recurrent cardiovascular events in patients who have had a heart attack”
The more complicated a treatment is, the more difficult it is for the patient to adhere to, and hence the advantages of the new ‘three-in-one’ polypill that includes aspirin, atorvastatin and ramipril. Before arriving at it, studies were carried out to check the necessary amounts of each of these drugs, as well as their efficacy, safety, and their stability within the pill.
In the FOCUS study, which had been previously published in the Journal of the American College of Cardiology (JACC), the CNIC researchers had already shown that the prescription of their polypill significantly improved adherence to treatment among patients recovering from a myocardial infarction. Trinomia began to be available in 2008, but it was not until 2014 that the Spanish Medicines Agency gave the go-ahead for its dispensing in Spain, and in 2015 it began to be marketed.
This team of scientists launched the SECURE study, an international randomized clinical trial involving 2,499 patients from seven European countries (Spain, Italy, Germany, the Czech Republic, France, Poland and Hungary) who were recovering from a heart attack, with the aim of verifying whether the improvement in adherence to treatment with the polypill was linked to a decrease in cardiovascular events.
The polypill tested in the study contains aspirin (100 mg), the angiotensin-converting enzyme inhibitor ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). Patients who participated in the study were randomly assigned to receive standard treatment or the polypill. The average age of the participants was 76 years and 31% were women. 77.9% had hypertension, 57.4% had diabetes, and 51.3% had a history of smoking.
The researchers looked at 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 its results were conclusive: patients taking the CNIC polypills had a 24% lower risk of these four events than patients taking the three drugs separately.
The most relevant finding of the study is the impact of the polypill on the reduction of deaths related to cardiovascular diseases, since it showed a relative reduction of 33%: from 71 patients in the group that received standard treatment to only 48 in the group that received standard treatment. that the polypill was prescribed. In addition, it was found that patients in the polypill group had a higher level of adherence to treatment than those in the control group – which confirms the findings of the previous FOCUS study – and this good adherence seems to explain in part the benefits of the simple polypill.
“The polypill, being a very simple strategy that combines three essential treatments for this type of patient, has demonstrated its effectiveness because the improvement in adherence means that these patients are receiving better treatment and, therefore, have a lower risk of recurrent cardiovascular events”, highlighted Dr. Castellano.
“The findings of the SECURE study 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”, concludes Dr. Fuster.
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