This could become an integral part of global strategies to prevent adverse cardiovascular events in this patient population
From: Mt. Sinai Health System [press release]
August 26, 2022 -- A
three-drug medication known as a “polypill,” developed by the Spanish 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
findings from the SECURE trial led by Valentin Fuster, MD, PhD, Director of
Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital, and
General Director of CNIC.
The study results were
announced Friday, August 26, in a Hot Line session at the European Society of
Cardiology Congress (ESC 2022) in Barcelona, Spain, and 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,”
says Dr. Fuster.
Patients recovering
from a heart attack—also known as myocardial infarction—are prescribed specific
treatments to prevent subsequent cardiovascular events. Standard therapy
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, fewer than 50 percent of patients consistently adhere to
their medication regimen.
“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
explains.
“Adherence to treatment
after an acute myocardial infarction is essential for effective secondary
prevention,” said José María Castellano, MD, study first author and Scientific
Director of Fundación de Investigación HM Hospitales.
CNIC scientists first
demonstrated that prescription of their polypill significantly improved
treatment adherence among patients recovering after a myocardial infarction, in
the FOCUS study, previously published in the Journal of the American College of
Cardiology (JACC).
The CNIC team launched
the SECURE study, an international randomized clinical trial, to determine
whether the improved treatment adherence with the polypill translated into a
reduction in cardiovascular events. The polypill analyzed in the study,
commercialized 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, 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 2,499
patients from seven European countries (Spain, Italy, Germany, the Czech
Republic, France, Poland, and Hungary) recovering after a heart attack. Study
participants were randomly assigned to receive standard therapy or the CNIC
polypill. The average age of the participants was 76 years, and 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 smoking tobacco.
Researchers analyzed
the incidence of four major cardiovascular events: death from cardiovascular
causes, non-fatal myocardial infarction, non-fatal stroke, and need for
emergency coronary revascularization (the restoration of 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 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 percent,
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, thus confirming the findings of the earlier FOCUS study, and in part
such good adherence appears to explain the benefits of the simple polypill.
“The 33 percent
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,” adds Dr. Fuster.
The SECURE trial was funded by the European Union Horizon 2020 research and innovation program (trial identifier NCT02596126
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