Source: The Independent
Date: 26 April 2004

A new pill for all ills

Statins are a cure-all to rival aspirin. They prolong life expectancy and treat heart disease, diabetes and MS. So should we all be taking them?
By Roger Dobson

It may be one of the cheapest pills on the market at less than £1 a time, but it might save your life, whatever your problem. Not only does it lower cholesterol levels and sharply reduce the risk of heart problems and angina; it may have benefits for many other diseases too, from dementia, multiple sclerosis and arthritis to macular degeneration, osteoporosis and infections.

Increased life expectancy, and even enhanced cognitive skills, could also be within the repertoire of this family of drugs - called statins - whose versatility is challenging the status of aspirin as the leading cure-all. Within months, this drug could be available over the counter at the chemist's shop. So should we all take it?

"Statins are highly effective and extraordinarily safe, and I think people of 55 and over should consider taking them daily. In general, people of any age who have had a heart attack or stroke should use them,'' says Professor Nicholas Wald of the Wolfson Institute of Preventive Medicine, one of the two doctors who put forward the idea of a universal Polypill earlier this year.

The prospect of "statins for all" is coming closer, with a government decision imminent on plans to make one statin drug available over the counter rather than on prescription only.

Unlike many drugs, the reputation of statins has grown on the back of real performance rather than expectations. Since they were introduced in the UK a decade or so ago, the status of statins has grown steadily as impressive results showed it to be not only highly effective, but safe too, with few side effects. It is estimated that about 10,000 lives are saved each year in the UK by its cholesterol-lowering effect alone. Worldwide sales are predicted to exceed £20bn within a decade.

The drugs were conceived as a way to reduce cholesterol levels. They block an enzyme involved in the liver's production of cholesterol, preventing excess amounts from getting into the blood and furring up arteries. Statins can cut cholesterol levels by up to 40 per cent, and new super-statins will be able to do even better.

Statins, formerly known as 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors, act as an anti-inflammatory, preventing plaques that build up in the arteries from rupturing and forming clots that can lead to heart attacks. They reduce levels of triglycerides, or human fats, and increase good cholesterol.

The fact that statins work effectively in the field of heart disease is now universally accepted, and it's been suggested that making statins available to more people could reduce heart attacks by one-third. One British team has said that giving statins to an extra 10 million high-risk people would save 50,000 lives a year.

Statins have mainly been used to treat high cholesterol, but researchers say guidelines should be changed so that a statin is considered for anyone at increased risk of a heart attack. Research based on 20,000 adults aged over 40 suggests that after five years the risk of heart-related deaths was reduced by 18 per cent and the likelihood of a non-fatal heart attack by 25 per cent.

Professor Neil Poulter of Imperial College, London says: "Just 20 years ago people were arguing over whether cholesterol was important. That has all gone, and now we are looking at how good statins are and how many people should get them. Trial evidence suggests that 40 per cent of the population could benefit.

"There are potentially very exciting other benefits, such as with osteoporosis, and there are studies looking at that and other conditions. Lots of people are looking at lots of things, but that should not detract from what we already have in the bag for coronary heart disease and stroke.''

Research in these other areas is continuing apace. It has been shown that statins can reduce the risks of diabetes and stroke, and strengthen bones and help to reduce the risk of osteoporosis. Still more studies have reported on how the drugs can reduce hip fractures, and lower the risk of dementia.

Some work suggests that patients who have had a heart attack or severe chest pain can cut the risk of a subsequent stroke by 22 per cent. Doctors have found that statins reduce blood levels of a protein associated with the severe arterial inflammation that leads to strokes. "We found that 70 to 80 per cent of patients who took any of these statins lowered the levels of this protein to below the level at which the risk of heart attack or stroke increases dramatically,'' says Dr Ishwarlal Jialal, who led this research at the University of Texas.

Statins are also thought to help prevent infections in people with diabetes, and researchers say diabetic patients on statins have a 20 per cent lower risk of developing leg infections. Their risk of dying from the infections was more than 70 per cent lower. One theory is that the drugs have some kind of effect on the ability of infection-fighting cells to travel to parts of the body.

Statins may protect against the progress of multiple sclerosis. "Our study shows that statins modify several molecules of the immune system involved in the disease progression of MS, independent of their use with interferon," says Dr Juan José Archelos of the University of California. "The potent anti-inflammatory effects of statins are remarkable, and even more effective when combined with interferon-beta."

Some research suggests that the risk of developing Alzheimer's disease is lower among people treated with statins, although the reason is unclear. One group found evidence that the drugs improve blood flow by relaxing the very small blood vessels in the brain. Another theory is that they block the effects of a chemical or protein implicated in the disease.

Osteoporosis researchers believe that statins encourage the growth of new bone cells. One team who tested 30,000 drugs for compounds that would stimulate the production of a protein critical to bone formation found that only statins worked.

Men and women aged over 50 who take statins are less likely to suffer hip fractures, with one study based on 6,110 adults showing that the use of statins was linked to a 43 to 50 per cent reduction in hip-fracture risk. Work on animals shows that statins can increase bone formation by almost 50 per cent in less than a week.

Age-related macular degeneration, resulting in loss of vision, is yet another candidate for statins. Research has shown that adults taking the drug were almost six times less likely to show signs of degeneration. One theory is that statins stop or slow retina cell death, improving blood flow to the macula (the central area of the retina).

Doctors in Scandinavia have shown that long-term therapy with statins substantially reduces the risk of death from all causes in middle-aged patients with heart disease and raised cholesterol. "It wasn't just fewer heart attacks or less chest pain; there was a true survival advantage," says their report.

Statins are a key element in the concept of the Polypill put forward by Professor Wald earlier this year. It was estimated that one in three people aged over 55 taking the Polypill, which would also include folic acid, aspirin and blood-pressure drugs, would benefit and gain an average of 11 years free of stroke and heart attacks.

"We put statins in the Polypill to prevent heart attacks," Professor Wald says. "I don't think it would have as great an effect on strokes. The Polypill strategy could largely prevent heart attacks and stroke if taken by everyone aged 55 and older, and everyone with existing cardiovascular disease. It would be acceptably safe, and with widespread use it would have a greater impact on disease prevention in the Western world than any other single intervention."

The Government is considering an application for one of the statin drugs to be available over the counter. Consultation over the idea has been completed, and a decision is imminent. The idea is that pharmacists would be able to supply the drug, Zocor, after simple health checks.

When he launched the consultation exercise, the Secretary of State for Health, John Reid, said: "Just as people have the choice to give up smoking and improve their diet, we want them to be able to choose a medicine that will reduce the risk of coronary heart disease.''

Should the drug become freely available as expected, it would be following the path of that other universal drug, aspirin. Its use would probably increase dramatically overnight, and links with other diseases, however tenuous, will boost usage to levels that will rival aspirin. That's not bad going for a drug that as recently as two decades ago was at the centre of controversy because of concerns that lowering cholesterol would result in an increase in violent behaviour and suicide.

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