Pill could slash heart problems

April 19th, 2009  |  Published in Clinical Matters

Healthy people who take a daily “polypill” combining a statin, aspirin and three drugs that lower blood pressure can halve their chances of a heart attack or stroke, a study suggests.

The long-awaited findings of the Tips trial, presented yesterday at a meeting of the American College of Cardiology in Florida, showed that the single-pill formulation can be used to prevent multiple health conditions and is well tolerated by patients.

People taking the polypill enjoyed the benefits of the five individual therapies: the statin reduced cholesterol, the three antihypertensives reduced blood pressure, and the aspirin reduced the clotting ability of the blood.

The research – in India – involved more than 2,000 people aged 45 to 80 and was the most comprehensive study yet of the “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 halved the number of heart attacks, strokes and other cardiovascular problems.

Although the researchers did not examine death rates, the figures suggested that it could result in thousands of lives being saved each year.

Almost 200,000 Britons are killed each year by heart and artery disease. A fifth of all deaths before the age of 75 in men and 10 per cent of those in women are due to cardiovascular disease.

Since the study looked at a relatively low-risk population, it suggested that the polypill might have a significantly bigger impact in practice. The pill, which would be most appropriate for those over 55, could end the need for complex screening, reduce the number of doctors’ appointments and might be sold for less than £1 a day.

Malcolm Law, of the Wolfson Institute of Preventive Medicine in London, said: “This study shows that it is possible to make such a product that is effective and doesn’t have adverse side-effects.”

Professor Law added that the drugs were “off-patent and cost pennies. You might be talking in terms of 50p a day. There’s no way it is going to drain resources. It is 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 about 75 per cent, he said.

The Indian Polycap Study (Tips), led by Salim Yusuf, of McMaster University in Hamilton, Ontario, was based on 2,053 people at 50 centres in India. They were split into nine groups and given different drug combinations for twelve weeks without knowing what they were taking. One group received a 100mg Polycap pill a day. The others took aspirin, a statin or a blood pressure-lowering drug alone, or different combinations of blood pressure-lower-ing drugs with or without aspirin.

The results showed that the components worked as well when combined into one pill as they did on their own. The statin simvastatin lowered cholesterol slightly less when incorporated 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 Lancet, the authors said that 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.

Peter Weissberg, the medical director of the British Heart Foundation, 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 the Stroke Association, said that combining medications would make it easier for people to stick to their treatment regimes.

Christopher Cannon, of Harvard Medical School, wrote in The Lancet: “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.”

Times Online

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