Increased doses of 'miracle' heart drug needed to save lives

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They are the miracle drugs of the 21st century and already they have saved tens of thousands of people with heart disease around the world. But doctors say the cholesterol-lowering medicines called statins, whose impact on heart disease has been compared to that of penicillin on infectious disease 60 years ago, have been prescribed in doses that are too low.

They are the miracle drugs of the 21st century and already they have saved tens of thousands of people with heart disease around the world. But doctors say the cholesterol-lowering medicines called statins, whose impact on heart disease has been compared to that of penicillin on infectious disease 60 years ago, have been prescribed in doses that are too low.

Heart specialists say patients need up to eight times more statins than the present recommended dose to give maximum protection against heart disease. But they warn that the new evidence on the best way of tackling heart disease has huge cost implications which could bankrupt health systems.

An estimated 200 million people worldwide need treatment for heart disease but fewer than 25 million are taking statins. In Britain, some doctors have estimated that up to eight million people could benefit from treatment with the cholesterol-lowering drugs but only one million are receiving them.

A US study of more than 4,000 patients which compared high- and low-dose statins found those on the high dose (80 mgs of atorvastatin) had 16 per cent fewer coronary events, including heart attacks, and a 28 per cent reduction in deaths from all causes. Coronary heart disease causes 120,000 deaths and 275,000 heart attacks a year in Britain, so reductions of this order would save tens of thousands of lives.

The benefit of the higher dose of the drug became clear within a month and persisted through the three years of the study, at the Brigham and Women's Hospital and Harvard Medical School in Boston. The results, to be published in the New England Journal of Medicine, were released online yesterday. An editorial says the findings herald a "sea change in cardiovascular prevention".

More than a decade ago, statins were established as the most effective drugs in the treatment of heart disease, with initial falls of 25 per cent in heart attacks. The benefits were so dramatic that by the mid-1990s prominent heart specialists were predicting that heart disease would be eliminated by the end of the century.

Later studies showed even greater effects. A European trial involving 19,000 patients, of whom 9,000 were from Britain, published in 2002, showed statins cut the incidence of heart attacks and strokes by a third. The size of the effect astonished researchers because the patients had normal cholesterol levels and were considered at only moderate risk of heart disease.

The effects on heart disease were so great that researchers asked whether they could all be attributed to the reduction in cholesterol. Statins have since been shown to have beneficial effects in a wide range of diseases, including multiple sclerosis, Alzheimer's and some types of cancer which doctors believe may be attributable to their anti-inflammatory action.

But the optimum dose of statins remained unclear and new trials have been established to compare different doses. The trial at Brigham and Women's Hospital is one of the first to report and the Journal describes the findings as a "major surprise" and a "turning point". But it warns that for most patients the problem is getting access to the drugs. "Only a fraction of the patients who should be treated with a statin are actually receiving such therapy," it says. "One of the most important reasons for this degree of under-treatment is cost, and more aggressive use of statins may exacerbate the problem."

Statins take up the largest proportion of the US drugs bill at $12.5bn (£6.8) a year. In Britain, where prescribing has not caught up with the latest research, spending is estimated at £700m. The Wanless review of future costs on the NHS published in April 2002, estimated spending would reach £2.1bn by 2010 as more patients were prescribed the drugs. But the Journal study results are likely to increase that bill. The recommended starting dose of atorvastatin is 10 mgs a day which costs £216 a year per adult in the UK. If this were increased, as recommended, to 80 mgs a day, the cost would rise to £360 a year. That could fall after 2010 as statins come off patent and patients switch to cheaper generic drugs.

Tom Bowker, a heart specialist at the British Heart Foundation, said: "The more you can reduce cholesterol the more you are likely to gain from it. But weight, smoking and age are all important. You have to look at the patient as a whole."

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