The statin debate

Sharon Collins / 01 August 2007

Statins have been hailed as wonder drugs that save lives, but not everyone is convinced. What's the evidence for and against cholesterol-lowering medication?



Statins are regarded by many doctors as genuine life-savers that protect against heart disease and strokes by reducing levels of blood cholesterol. There have also been suggestions that they have other, unexpected benefits too – including a lowered risk of Alzheimer’s disease.

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However, some patients are saying their doctors won’t take them seriously when they complain of unpleasant side effects from taking statins or refuse to accept that the drugs are responsible.

The range of symptoms ascribed by some patients to statins is wide – from itchy scalp to muscle pain by way of breathlessness and insomnia. So it’s not surprising that doctors find it difficult to distinguish genuine side effects from symptoms that are purely coincidental and unrelated to the medication.

The balance of evidence from medical trials suggests statins are safe and effective and relatively free of significant side effects. It’s a view that Dr Mike Schachter endorses, but with which Macclesfield GP Dr Malcolm Kendrick disagrees.

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Dr Mike Schachter investigates how statins work in people. He's also a general physician at St Mary's Hospital, London.

Cholesterol is the single greatest risk factor for heart disease and a major risk factor in stroke and disease of the arteries. Statins reduce harmful cholesterol by slowing its production in the liver.

They’re proven to reduce heart attack and stroke by reducing harmful cholesterol which thickens arteries and increases risk of clots. A review of 90,000 statin users by the Medical Research Council in Oxford and the University of Sydney concluded that risk of fatal heart attack or stroke fell by about a third.

Benefits started immediately, increased the longer they were taken and the further cholesterol fell. It reported statins are especially valuable to people at high risk of heart attack or stroke and they protect patients whose cholesterol was considered normal.

Statins as life savers

There’s no question that statins save lives. Cardiovascular disease is the nation’s biggest killer causing 238,000 deaths a year. It’s estimated by Roger Boyle, the government’s National Director for Coronary Heart Disease, that statins save 9,000 lives a year in the UK. They particularly benefit those who have suffered heart attack or stroke, or have angina or peripheral arterial disease.

Statins have been tried and tested for 20 years. They’ve been in use for over a decade and most trials, involving tens of thousands of patients, continued for five years or more.

Dr Kendrick uses studies selectively. He doesn’t mention the trials involving tens of thousands of people showing benefit from statins. He focuses entirely on the negative. Equally you don’t have to believe that the whole population should be on statins. I certainly do not.

Statin side effects

As well being effective statins are usually well tolerated by patients who can expect to stay on them for life. Trials show they’re relatively free of adverse side effects and that most people take them without trouble, but as with any effective drug, there are associated risks including diarrhoea, flatulence, headaches, fatigue, sleeplessness and liver problems. Statins cause some users to have difficulty climbing stairs, lack energy and have painful muscles after exercise. These side effects must of course be taken into account and if they persist or get worse then the drugs must be stopped. But this is not the case for most people taking statins.

More serious muscle breakdown occurs rarely and is usually reversible on stopping the drug. In a very small number of cases muscles can be damaged but is rarely life-threatening. Muscle damage caused by one statin, cerivastatin (Baycol) was severe and widespread enough – it killed several hundred people -for it to be withdrawn in 2001.

There’s nothing to suggest the statins currently available – [simvastatin (Zocor), pravastatin (Lipostat), fluvastatin (Lescol), atorvastatin (Lipitor) and rosuvastatin (Crestor)] are anything like as dangerous and there’s little between them in terms of risks.

Memory loss is reported by some but two large trials found no difference in cognitive loss and dementia in older patients. Sometimes statin users develop liver problems but it’s unclear whether these are more common in this group than in non-users. There are only two cases in the world of serious liver damage. Liver tests are usually done before treatment starts and during therapy.

Side effects certainly do occur but the Dutch survey Kendrick mentions doesn’t reveal what percentage of patients would have suffered such problems if they were taking a placebo tablet.

Women and statins

While there’s widespread agreement that both sexes with heart disease should be offered statins, there’s debate about whether women at moderate risk of heart attack and stroke should have them.

Trials of men and women at moderate risk show a reduced risk with statins but not enough women participated to produce definitive results. Until a large-scale trial assesses effectiveness in moderate risk women, statins should be avoided in most lower risk women. But for those at moderate risk, the drug should not be ruled out.

While there’s some evidence that taking Co Q10 may reduce risk of muscle damage and other side effects, no large studies confirm this. Current guidelines do not recommend routine use in statin users although it appears to be safe.

Any side-effects must be taken seriously and acted upon if they cause the patient serious inconvenience or discomfort, not to mention added risk of potentially life threatening muscle problems.

Doctors are advisers and can’t dictate what patients should take. Unless you feel acute discomfort it’s best to talk to your GP before stopping statins. Alternative medication is possible or perhaps coming off statins and waiting and watching to see what happens to cholesterol, according to the patient’s risk of heart attack or stroke. There are disagreements as to whether stopping statins suddenly is harmful: we’re simply not sure.

The case against statins

Dr Malcolm Kendrick argues that disadvantages of statins outweigh possible benefits for the majority of people. Statin prescribing is increasing by 30% each year and soon everyone over 50 will be told they need them

I tell patients with a cholesterol level of between 5 and 7 they’re healthy. If it’s above 7, it’s probably due to a family history of high cholesterol and if any relatives have early heart disease then it’s worth taking a statin.

The body needs cholesterol - 25% of it is in the brain and is vital for it to function properly. For patients who have suffered heart attack or stroke or have existing cardiovascular disease (disease of the heart and blood vessels) taking a statin can benefit them. But, the real question is by how much?

Patients should ask doctors, “How much longer will I live if I take a statin?” The answer is, not very long. If you’re at high risk of heart disease or stroke and you take a statin for 30 years, you’re likely to live an extra nine months.

I believe statins have substantial side effects which can significantly affect quality of life. Some studies suggest such problems may be much more common than is recognised.

Side effects of statins

A Dutch survey of 4,738 statin users asked about side effects. Just over a quarter (27%) said they suffered from them. Around 40% of these sufferers experienced muscle pain and almost a third (31%) had joint pain. It also reported that 16% had digestion problems and 13% had memory loss.

Other research shows patients who had definite or probable side effects tended to be dismissed by their doctors who denied any specific statin-linked side effects and failed to appreciate the effect on their life.

If you have problems ask your GP if your statin could be causing them and if it’s possible to reduce the dose.

Women and statins

To date, no large trial of women statin users who already have cardiovascular disease has been shown to increase life expectancy by one day. More importantly, the use of statins in women at lower risk has not increased life expectancy nor prevented heart attacks and stroke.

It raises the question whether women should be prescribed statins at all. I believe that the answer is no. Statins fail to provide any overall health benefit in women. The more recent heart protection study was hailed as a success for men and women, but despite the hype there was no effect on mortality in women.

If you’re on a statin because you’re at high risk of cardiovascular disease and you have muscle pain, it’s worth taking the vitamin-like substance Coenzyme Q 10. Statins cause levels of this to fall in the body. I’ve seen no evidence that taking it causes harm.

The Great Cholesterol Con by Malcolm Kendrick, John Blake Publishing, £9.99.



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