A low-cost polypill, which combines four cardiovascular drugs into a single pill, has cut the risk of major cardiovascular events in the first trial of its kind, researchers report today.
The once-daily polypill has the potential to reduce the burden of cardiovascular disease, especially in low- and middle-income countries, say the researchers, reporting in The Lancet.
PolyIran, the first large randomised trial of its kind, which involved almost 7,000 people in Iran, aged 50–75, concluded that the polypill reduces the risk of heart attack, stroke, and heart failure by more than a third over five years compared with lifestyle advice alone (202/3,421 [6%] vs 301/3,417 [9%]).
The findings demonstrate for the first time the effectiveness of a fixed-dose polypill, which combines two commonly used blood pressure lowering drugs, a cholesterol-lowering medicine, and aspirin, for both the primary and secondary prevention of CVD.
Participants who took the polypill as prescribed for at least 70% of the time saw the strongest protective effect against future cardiovascular events, cutting their risk by 57%. This is compared with only (86/2,144 [4%] vs 301/3,417 [9%]) of those given lifestyle advice. The authors did not observe a corresponding improvement in blood pressure.
Lead researcher Professor Reza Malekzadeh from Tehran University of Medical Sciences said: “The idea of the polypill has always been appealing, and now we know that a fixed-dose polypill can achieve clinical benefits in practice.
“Because the risks of side-effects from the components are very low, and the potential benefits are very high, the polypill is very safe. In terms of risk reduction, we can see the people who benefit most are those with high adherence. But the polypill is not an alternative to a healthy lifestyle and should be combined with physical activity, a healthy diet, and smoking cessation.”
Professor Tom Marshall, of the University of Birmingham, UK, said this is the largest trial confirming the value of the polypill and showing it is effective in primary prevention.
“Because they have most to gain, the most efficient strategy would be to offer the polypill to those at highest risk of heart disease,” he added.
The study recruited 6,838 people from the Golestan Cohort, a study tracking the health of more than 50,000 adults from the Golestan province in Iran between February 2011 and April 2013.
About one in 10 (737) had a history of CVD, and of these, 588 were taking other cardiovascular drugs at the start of the study.
Researchers randomly assigned the villages in which participants lived to lifestyle advice (116 villages; 3,417 participants) or a once-daily polypill plus lifestyle advice (120 villages; 3,421 people).
Compared with lifestyle advice, taking the polypill reduced the risk of major cardiovascular events by 34% overall and by about 40% in individuals without a history of CVD over five years (136/3,033 [4.5%] vs 229/3,068 [7.5%]).
It also reduced the risk by approximately 20% in those with previous CVD (66/388 [17%] vs 72/349 [21%]).
Systolic and diastolic blood pressure did not differ significantly between the groups, but LDL cholesterol was significantly lower in polypill cohort. Overall, the polypill was well tolerated and adverse events were similar between the groups.
Dr Nizal Sarrafzadegan, Isfahan University of Medical Sciences, Iran, said: “Given the polypill’s affordability, there is considerable potential to improve cardiovascular health and to prevent the world’s leading cause of death.
“Over three-quarters of the 18 million people who die from cardiovascular diseases each year live in low- and middle-income countries, and a fixed-dose polypill strategy, if adopted widely, could play a key part in achieving the bold UN target to reduce premature mortality due to cardiovascular disease by at least a third by 2030.”
Roshandel G, Khoshnia M, Poustchi H et al. Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial. Lancet 23 August 2019
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