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Everyday drugs: The great statins debate

They're one of the most widely prescribed medicines in the world and save many thousands of lives each year – but the worries about side effects won't go away
Everyday drugs: The great statins debate

“For every heart attack prevented, more people will be taking statins for no benefit” (Image: BSIP/UIG/Getty)

One of the most widely prescribed medicines in the world, statins are thought to reduce the risk of heart attack and stroke by lowering blood cholesterol levels, and are now taken by one in four adult Americans over 45. However, once hailed as wonder drugs, they have hit the headlines in recent years over safety concerns and their use in healthy people.

The guidance used to be that statins should be prescribed to anyone who has had a heart attack or stroke. But, increasingly, people with no history of heart problems are offered them too.

In the UK, anyone deemed to have a 20 per cent risk of developing cardiovascular disease in the next decade would have qualified for a daily dose of statins – until last year. Then, following an analysis of 27 trials, the National Institute for Health and Care Excellence (NICE) lowered the threshold to a 10 per cent risk. The risk is calculated using factors like smoking, age, ethnicity and BMI (body mass index – an indicator of being under or overweight), as well as blood pressure and cholesterol levels.

That equates to an extra 5 million people on top of the estimated 7 million already taking statins in England and Wales alone. In the US, the threshold is even lower: the drugs are recommended to those with a 7.5 per cent risk of heart attack, after new guidelines came out in 2013.

NICE estimates that its strategy could prevent 28,000 heart attacks and 16,000 strokes every year. And statins are cheaper than treatment after the event.

But their increased use has met with strong resistance from doctors and patients suspicious of the notion of treating people who are not unwell.

For one thing, it means that for every heart attack prevented, more people will be taking the drug for no benefit. “For low-risk people, with a risk of, say, 10 per cent, taking statins will reduce it to about 8 per cent. A 2 or 3 per cent difference in risk of having a cardiac event is not very big,” says Klim McPherson of the University of Oxford. “If you’re expected to take a drug every day, you’ve got to wonder whether it’s worth the gamble.”

“For every heart attack prevented, more people will be taking statins for no benefit”

For many that gamble is the possibility of side effects. A study and subsequent article in the BMJ questioned the data behind the NICE recommendations, warning that some trials included in the analysis were funded by statin manufacturers and that data on side effects was lacking.

Patients taking statins often anecdotally report muscle pain, although this has not been seen in the major, placebo-controlled trials. The BMJ article said that one in five people on statins experiences a side effect of some kind, although it later withdrew this claim after Rory Collins at the University of Oxford, a leading statin researcher, spoke out against the accuracy of the statistics.

Yet the anecdotal reports continue to surface. “Some doctors say they keep seeing patients with the same complaint and they feel it’s due to the statin,” says David Preiss of the University of Glasgow. “It doesn’t look that way from the trials, but we need a better answer.”

There does seem to be a link to diabetes. Preiss has studied the connection between statins and type 2 diabetes. He says taking a medium-dose statin raises your risk by 10 per cent, and the risk continues to rise in line with dosage. “These are modest changes – people who are probably already on the trajectory to diabetes, and the statin pushes them over the threshold.”

In light of all the concerns, Collins is undertaking a major review of the data on side effects, which he hopes will reassure people. That’s important, he says, because fears over statins are discouraging people from taking them, to the detriment of their health.

The results should be out later this year. In the meantime, if you’ve ever had a heart attack or stroke, you should be on a statin if possible, says Preiss. “And if you haven’t, but you’ve been shown to be moderately or markedly at risk of having a heart attack, the benefits of a statin considerably outweigh any risks.”

No one should pin all their hopes on a pill in any case. Taking statins should be accompanied by lifestyle changes such as taking exercise and giving up smoking.

Read more: “Our daily pills: What everyday drugs are really doing to you“