A four-in-one pill could save thousands of lives by slashing the risk of heart attacks and strokes, a major study suggests.
Researchers analysed almost 7,000 people, half of which took the so-called ‘polypill’ every day for five years.
The pills, made up of aspirin, a statin and two blood pressure drugs, were found to reduce the chances of cardiovascular events by 34 per cent.
This was compared to the participants who relied on healthy lifestyle habits alone, such as eating a low-sugar diet, exercising and not smoking.
Experts praised the drug’s potential to ‘reduce heart disease worldwide’ – but one warned aspirin may be unsuitable given its bleeding risk.
The polypill studied contained aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan.
Results of the study, which involved a team at the University of Birmingham as well as doctors in Iran, were published in The Lancet.
A four-in-one pill could slash a person’s risk of heart disease by more than a third (stock)
Lead author Professor Reza Malekzadeh, of the University of Tehran, said: ‘The idea of the polypill has always been appealing.
‘And now we know 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.’
Heart disease is responsible for one in four deaths in the UK and US, statistics show.
Poor adherence is a serious issue among heart disease patients. Research suggests around a third of people stop taking their medication as soon as 90 days after a heart attack.
The polypill concept was first put forward almost 20 years ago as a simple, inexpensive way to reduce heart disease, while also encouraging good drug adherence.
Since then, different formulations and doses have been tried but the medication’s effect on heart disease remained unclear, the researchers wrote.
A polypill-style drug is ‘not yet widely available to clinicians and patients’, they added.
In the first large study of its kind, the team analysed 6,838 people, aged 50-to-75, who took part in the Golestan Cohort.
This was a 50 year study that tracked the health of more than 50,000 adults living in the Golestan province in Iran.
Around one in 10 (737) of the participants had a history of a history of heart disease, of which more than three quarters (588) were taking cardiovascular medication.
Of the overall participants, 3,421 were told to take polypill every day, alongside lifestyle advice, while the remaining 3,417 were only given heart health tips.
Over the five years, those in the polypill group were 34 per cent less likely to suffer a major cardiovascular event.
Among those with no history of heart disease, the risk was reduced by around 40 per cent.
The participants who had already suffered a heart attack, stroke or heart failure saw their risk go down by around 20 per cent.
The results were similar among both men and women, and people of different ages.
After adjusting for the potential protective effect of any other drugs the participants may have been taken, polypill was found to reduce the risk of heart disease by 20 per cent. This was still statistically significant.
The results also suggested that out of every 35 people who take polypill, one is protected from a serious cardiovascular event.
Among those who take the drug as prescribed 70 per cent of the time, just 21 people need to be treated for one person to benefit.
Perhaps surprisingly, blood pressure did not differ between the two groups, however, those who took polypill had lower cholesterol levels.
The study did not set out to uncover how polypill affects a person’s risk of premature death, however, the results suggest the drug does not influence mortality.
In terms of safety, polypill was ‘well tolerated adverse events were similar between the groups’.
‘Given the polypill’s affordability, there is considerable potential to improve cardiovascular health and to prevent the world’s leading cause of death,’ study author Dr Nizal Sarrafzadegan said.
‘Over three-quarters of the 18 million people who die from cardiovascular diseases each year live in low- and middle-income countries.
‘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 researchers stress they only tested two polypill doses, with other regimens potentially producing different results.
The study was also only carried out in Iran, with the participants largely being of central Asian ethnicity. The results may not therefore apply to other ethnic groups.
Writing in a linked comment, Professor Anushka Patel from The George Institute for Global Health in Australia, said: ‘Despite some limitations, this study makes a major contribution to the evidence-base for polypills in the prevention of cardiovascular disease (CVD) globally.
‘The findings are particularly important for low- and middle-income countries where 80 per cent of the global CVD burden resides and where, in general, even large preventive treatment gaps exist.’
Professor Kausik Ray, chair in public health at Imperial College London, said: ‘Lowering blood pressure and [bad] cholesterol are known to reduce cardiovascular events, like heart attacks and stroke.
‘In terms of prevention, aspirin does not provide major benefits and any small benefits are offset by an increased risk of bleeding.
‘In the study, the blood pressure lowering combinations are weak and generally we would use longer-acting, slightly more potent drugs, if these needed to be given once a day.
‘This study shows a ‘polypill’ is well-tolerated and has good adherence. The treatment helps to reduce blood pressure and cholesterol, and shows some cardiovascular benefits.
‘However, I do not agree aspirin should be used in the polypill. Instead, perhaps a more potent once-daily, long-acting blood pressure-lowering agent could provide more benefit to patients.’
Dr Amitava Banerjee, senior clinical lecturer in clinical data science at University College London, added: ‘Drugs do not work if they are not taken.
‘The polypill can reduce cardiovascular disease worldwide and can improve adherence to therapy.
‘The polypill approach could become part of preventive programmes to reduce cardiovascular disease globally but must not detract from the need for lifestyle change, such as smoking cessation and physical activity.’