An all-in-one “polypill” containing a cocktail of potentially life-saving drugs could halve rates of heart attacks and strokes in healthy middle-aged and older people, a major trial has found.
The research in India involved more than 2,000 people aged 45 to 80 and was the most comprehensive study yet of the controversial “magic bullet” pill.
Scientists compared Polycap, a five-drug polypill, with combinations of its different components to assess effectiveness and safety.
They concluded that if the pill was given to a population of healthy adults with at least one risk factor, such as raised blood pressure, obesity or smoking, it could slash the number of heart attacks, strokes and other cardiovascular events by half.
Although the researchers did not look at death rates, an effect of this size could result in thousands of saved British lives.
Since the study looked at a relatively low risk population, it suggests that the polypill might have a significantly bigger impact in practice.
Another important finding was that the pill was well tolerated and caused no unpleasant side effects.
Polycap contains a cholesterol-lowering statin, aspirin to combat clotting, and three blood pressure-lowering drugs.
Professor Malcolm Law, from the Wolfson Institute of Preventive Medicine in London, said: “We have long advocated the polypill as a safe and effective way of greatly reducing the incidence of heart attacks and strokes in the population.
“This study shows that it’s possible to make such a product that is effective and doesn’t have adverse side effects.” He said a polypill such as the one used in the study would be easily affordable and greatly reduce the cost burden of doctors’ appointments, blood and cholesterol tests, and treatment.
“These drugs are off-patent and cost pennies,” said Prof Law. “You might be talking in terms of 50p a day. There’s no way its going to drain resources.
“Its not going to make megabucks for anyone, but it’s a public health thing.” In a higher risk population, the polypill might be expected to reduce rates of heart attacks and strokes by around 75%, said Prof Law.
The Indian Polycap Study (Tips), led by Dr Salim Yusuf, from McMaster University in Hamilton, Ontario, Canada, looked at 2053 people at 50 centres in India.
Participants were split into nine groups and given different drug combinations for 12 weeks without knowing what they were taking.
One group received a single 100 milligram Polycap pill a day. The others, each with about 200 individuals, took aspirin, a statin or a blood pressure lowering drug alone, or different combinations of blood pressure lowering drugs with or without aspirin.
The results showed that the ingredients worked as well combined into one pill as they did on their own. The statin simvastatin lowered cholesterol slightly less when incorporated into into a polypill, but the difference was marginal.
There was no evidence that combining several active components in one pill increased unwanted side effects.
Writing in an early online issue of The Lancetmedical journal, the authors said the effect of Polycap on blood pressure alone could reduce the risk of heart disease by about a quarter and strokes by a third in average individuals.
The reduced levels of “bad” low-density lipoprotein (LDL) cholesterol seen could lead to a 27 per cent reduction in heart disease risk and an 8 per cent reduced risk of stroke.
“This Polycap formulation could be conveniently used to reduce multiple risk factors and cardiovascular risk,” said the researchers.
Professor Peter Weissberg, medical director at the British Heart Foundation (BHF), said the Tips study was the first to investigate properly whether polypills worked.
He said it was the first of a number of similar studies of different types of polypill that were expected to produce results over the next two or three years.
Prof Weissberg said: “This study basically shows that the polypill does what it says on the tin.
“What’s needed now are properly controlled outcome studies. It’s going to take five or six years before we really know if it’s worth having a polypill or not.” Joanne Murphy, research liaison officer at Britain's Stroke Association said: “High blood pressure and cholesterol are major causes of stroke and it is important that people take medication to combat these risk factors.
By combining these medications in one pill, it will make it easier for people to take their medication. However, it is important that more research and investigation is done into this pill to ensure its safety.” American expert Dr Christopher Cannon, from Harvard Medical School in Boston, questioned what the effect of a widely available polypill might be on lifestyles.
Commenting in The Lancet he wrote: “Would the availability of a single magic bullet for the prevention of heart disease lead people to abandon exercise and appropriate diet? Would this make two of the major root causes of heart disease worse? Hopefully not, but the medical profession would need to help ensure that this would not happen.”
PA