New study shows that a multi-pill, combining three drugs, makes it easier for patients to stick to prescribed treatment
A polypill containing aspirin, a statin and an antihypertensive drug reduces subsequent cardiovascular risk in patients who have already had a heart attack more than standard treatment in which the three drugs are given separately, according to a new clinical trial, the largest and longest of its kind.
The ground-breaking randomized and controlled final phase 3 study, led by Dr. Valentin Fuster, director of the National Cardiovascular Research Center (CNIC) of Madrid and Mount Sinai Hospital of New York, was presented at the European Society of Cardiology (ESC Congress 2022) in Barcelona, ​​while related publication it was also published in the American medical journal The New England Journal of Medicine.
Fuster stated that “the results of the SECURE study show, for the first time, that a polypill containing aspirin, atorvastatin, and ramipril leads to a clinically significant reduction in recurrent cardiovascular events in patients who have already suffered a myocardial infarction.”
After a heart attack, patients are prescribed drugs (antiplatelet, antilipid, antihypertensive) to prevent further cardiovascular events. But not even 50% of patients who have had a heart attack, do not consistently take all these medicines for a long time. The new study shows that a polypill that combines all three drugs makes it easier for patients to stick to the prescribed treatment and thus have better protection in the future, avoiding a second potentially fatal heart attack or another cardiovascular event.
The idea of ​​a polypill was first mooted about two decades ago, while polypills already exist for other conditions such as HIV infection and hepatitis C. SECURE was the first randomized trial to study the impact of a polypill on future cardiovascular events in patients who had had an initial heart attack within the previous six months.
They involved 2,500 patients with an average age of 76 years (31% women) who were divided into two groups: half received the usual treatment with separate drugs, while the other half took a polypill of different dosage, containing aspirin (100 milligrams), ramipril (2 ,5, 5 or 10 mg) and atorvastatin (20 or 40 mg). Patients were followed for up to three years. The clinical trial was conducted in 113 medical centers in Spain, Italy, France, Germany, Poland, the Czech Republic and Hungary.
During the study, 48 cardiovascular deaths occurred in the polypill group (3.9%) versus 71 (5.8%) in the control group. A subsequent nonfatal heart attack occurred in 101 patients (8.2%) in the polypill group versus 144 (11.7%) in the control group.
Overall, over the course of three years, 12.7% of patients in the control group had another heart attack or stroke, died of a cardiovascular cause, or needed emergency treatment to open a blocked artery, compared with 9.5% in the multipill group (24% risk reduction ).
Mortality from non-cardiovascular causes was similar in the two groups, while patients who took the polypill had, after six months, higher rates of consistent medication use (71%) compared to the control group (63%).
“The findings suggest that a polypill can be a key component of our strategies to prevent cardiovascular events in post-myocardial infarction patients. By simplifying treatment and improving adherence, the new approach has the potential to globally reduce the risk of recurrent disease or cardiovascular death.”
The new polypill will be submitted to the US Food and Drug Administration (FDA) for approval. The multi-pill is expected to be cheaper to produce and distribute than the three drugs separately, which is particularly important for low- and middle-income countries.
RES-EMP
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