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A low-cost pill made up of four cardiovascular drugs could significantly reduce the burden of heart diseases, especially in low- and middle-income countries, according to a study undertaken in Iran.

A paper published in The Lancet on 23 August showed that the so-called polypill, which combines different drugs into a single dose, reduced the risk of heart attack, stroke and heart failure by around a third.

The study is based on a five-year randomised trial involving 7,000 men and women aged between 50 and 75 years from the Golestan province in Iran.

“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,”

Nizal Sarrafzadegan, Isfahan University of Medical Sciences, Iran

Co-author Nizal Sarrafzadegan, of Iran’s Isfahan University of Medical Sciences, said: “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.”

The risk of suffering a major cardiovascular event among people taking the pill was 34 per cent lower compared to a control group that received regular treatment and lifestyle advice. Those who took the pill regularly - at least 70 per cent of the time - saw even greater effects, reducing their risk by 56 per cent.

The pill’s ingredients are aspirin, blood pressure drugs atorvastatin and hydrochlorothiazide, and enalapril, which lowers cholesterol. In some patients, enalapril can cause coughing, so another version using valsartan is also available.

Tom Marshall, co-author of the study and a professor at the Institute of Applied Health Research at the University of Birmingham in the United Kingdom, said: “All of these components are off-patent and therefore the cost is low.”

In Iran, where the pill is now available on the market, each pill cost 4.5 US cents.

Reza Malekzadeh, the director of Tehran University of Medical Science’s Digestive Disease Research Institute and co-author of the study, says that, while the best dose is one pill a day, a slightly lower dose would work for those struggling with the price.

“Five tablets a week is also very effective and could prevent up to 70 per cent of cardiac attacks,” he said.

Marshall explains that the pill was administered through Iran’s existing primary healthcare system and did not require any medical specialists. “The success of the study suggests that people are able and willing to take the medication for many years,” he told SciDev.Net.

The researchers stress that the pill should be seen as an additional component of cardiovascular disease prevention strategies, such as nutrition advice, advance screening, and other cardiovascular drugs. These services, however, can be difficult to deliver in underfunded health systems.

Leopold Aminde, a Cameroonian physician who researches cardiovascular diseases at the University of Queensland in Australia, thinks the polypill is a great option to combat heart disease, but should be accompanied by other population-wide strategies addressing risk factors, including an unhealthy diet, physical inactivity, excessive alcohol and smoking.

“It is possible that the availability of the pill could make people less likely to follow other recommendations for lifestyle changes,” he warned.

Policymakers in poor nations should also allocate resources to reducing unhealthy diets, physical inactivity and harmful drinking and smoking, Aminde added. The research team in Iran found that 13 per cent of the study participants discontinued treatment with the polypill during the duration of the study. They found that the pill did not significantly reduce overall mortality in the cohort, suggesting that, while there were fewer cardiovascular events, other health issues continued to affect the participants.

David Peiris, co-director of health systems science at Australia’s University of Sydney, says there remains a risk to “over medicalise” diseases primarily caused by lifestyle. “Many studies show that age-based screening and identification of high-risk individuals is the most cost-effective strategy,” he said. “We also need to watch out for overtreatment of lower-risk individuals.”

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