Eight million Britons may benefit from heart drug

Trials indicate that statins, which reduce cholesterol in the blood, could cut the death toll of the West's biggest killer disease

A drug that has been hailed as the "new aspirin" could benefit up to eight million people in Britain by cutting their risk of heart attacks and strokes, a heart specialist said yesterday.

The effects of the cholesterol-lowering drug, known as a statin, were so dramatic that researchers running a major European trial involving 19,000 patients announced yesterday that they had stopped part of the trial two years early to allow all patients to receive the drug immediately. A second part of the trial, examining blood pressure treatments, will continue.

Early results suggested that statin, whose brand name is Lipitor, could cut heart attacks and strokes by a third. Researchers were astonished by the size of the effect because the patients, including 9,000 from Britain, had normal cholesterol levels and were at only moderate risk of heart disease.

The trial is the second in the past year to demonstrate the dramatic benefits of statins. Initially they were thought to help only those at high risk of heart disease, but the latest results suggest people at low risk may gain significantly too.

Peter Sever, professor of clinical pharmacology at the Imperial College of Science, Technology and Medicine in London, and one of the trial co-ordinators, said: "There are eight million people with high blood pressure in Britain. If our results are correct, and I know no reason why they should not be because they are statistically highly significant, we could be potentially saving 20,000 to 30,000 strokes and heart attacks a year if they were all taking statins – but at a considerable cost."

Statins are priced at around £1 a day per patient, but the cost is likely to fall in 2006 when the first ones come off patent and generic versions are marketed.

Professor Sever said that to make statins available to everyone who could benefit from them on the NHS – a potential cost of almost £3bn – would "break the drug budget of most providers".

Professor Sir Charles George, medical director of the British Heart Foundation, said: "The potential benefits of statins are much broader than we at first thought."

On the basis of the latest findings, one in three adults over the age of 45 – all those with high blood pressure – might benefit from swallowing a cholesterol-lowering tablet each day.

Cholesterol is known to be associated with heart disease, and lowering the level of high-density lipoprotein, or "bad" cholesterol, has been an aim of health education campaigns. But efforts to achieve this by changes in the diet, such as eating less fat and more fruit and vegetables, have largely failed.

The discovery of drugs that would cut the level of cholesterol in the blood, independently of dietary habits, was the magic bullet that doctors had been seeking. Here was a simple, safe means of reducing the toll from heart disease and stroke that is the scourge of the Western world. Heart disease is the biggest single killer in Britain, affecting 2.2 million people and causing 135,000 deaths each year.

In November 2001, the most comprehensive trial of statins, known as the Health Protection Study (HPS), conducted in 69 British hospitals and involving more than 20,000 patients, found that it cut heart attacks and strokes by a third in high-risk patients. The findings were presented at a meeting of the American Heart Association in San Diego.

Professor Rory Collins, of the Clinical Trials Service Unit in Oxford, who led the study, described it at the time as a "stunning result with massive public health implications". He said the results were "at least as important as previous findings for aspirin's effects on heart attacks and strokes ... in fact, statins are the new aspirin".

Professor Sir Richard Peto, an Oxford University epidemiologist, said that in 30 years' work on clinical trials "this is far and away the most important set of results I've ever had anything to do with".

When the findings were published in The Lancet three months ago, they were described as "the most far-reaching results for the treatment and prevention of heart disease and strokes that we have seen in a generation".

Statins had, up to that point, mainly been given to middle-aged men with high cholesterol levels who had a history of heart disease or were at high risk of a heart attack. The new findings showed that they were also effective in women, in older people and in those who had average cholesterol levels.

Now the European trial, which researchers announced yesterday had been stopped, has confirmed and extended the earlier findings, suggesting that it could cut the risk of heart attacks and strokes by one third. After the HPS study, researchers suggested that the number of people taking statins should be doubled from one million to two million. Yesterday, Professor Peter Sever, who led the British arm of the European trial, said up to eight million people might benefit in the UK.