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Statins do not cause muscle pain or stiffness any more than a placebo – study

Lauren Hurley

By Ella Pickover, PA Health Correspondent

Statins do not cause muscle pain or stiffness any more than a placebo, a study suggests.

Many people have been put off taking the cholesterol-busting drugs because of the potential side effects.

But a new study found that the drugs – which are widely used to prevent heart attacks and strokes – are no more likely than a placebo to cause muscle problems.

Muscle aches and pains are common among older people, and “it’s not surprising people look for a cause for those”, one of the authors said.

The new trial, published in The BMJ, examined people who had recently stopped, or were considering stopping taking statins because of muscle symptoms.

These people were registered at 50 GP surgeries in England and Wales which were involved with the trial.

The study, called an “n-of-1” trial, saw participants given both the placebo – or a “fake” drug with no active medical substance – and atorvastatin at different periods over the course of a year.

But they did not know which drugs they were taking.

Around 200 participants were randomly assigned to a sequence of six, two-month treatment periods during each of which they received either statins or a placebo.

Participants, who were an average of 69.5 years old, were asked to report their muscle symptoms including pain, weakness, tenderness, stiffness, or cramp of any intensity.

Overall, the researchers from the London School of Hygiene and Tropical Medicine (LSHTM) found no difference in muscle symptom scores between the statin and placebo periods.

Most people completing the trial intended to restart treatment with statins, the authors noted.

Liam Smeeth, professor of clinical epidemiology at LSHTM and study senior author, said: “Statins are remarkably effective drugs – they reduce the risk of heart attacks, strokes and dying of vascular disease by between a quarter and a third.

“In 2013 there were quite a few articles published, and a lot of reports going around the place, that statins caused crippling muscle side effects – pain and stiffness.

“And this led to a big movement of people kind of calling themselves statin deniers or statin sceptics, saying ‘well maybe these risks outweigh the benefits’.

“And we showed quite convincingly that these reports could lead to quite marked reduction in the use of statins, and indeed lead to a lot of people giving up taking their statins – and of course if you give up taking statins, you lose all the benefits and we know your risks of heart attacks and strokes go up by something like 30%.”

He continued: “I’m certainly not a sort of statin pusher in any sense, I think people need to make informed decisions.

“What we’ve clearly shown is that even among this group of people – who had been specially selected because they had problems taking statins – what we saw was in almost all cases their pains and aches were no worse on statins than they were on placebo.

“So I’m hoping it can change minds a bit and reassure people.”

He said: “These drugs prevent heart attacks and save lives.

“In very rare cases they can cause muscle pain, but the vast majority of people will not be affected. The benefits far outweigh the risks.”

When asked what did cause some of the muscle pain seen among people in the study, he added: “Most of our treatment groups were people in their 70s – aches and pains are sadly pretty common in people in their 70s, and it’s not surprising people look for a cause for those.

“But we didn’t go into great detail what was causing their aches and pains, but show was that it wasn’t any worse on statins than on placebo.”

The authors said that using this type of trial meant they were able to make the assessment using smaller numbers because the study compared both aspects of the trial in the same participants.

Other studies use larger participant numbers because they compare like-for-like participants, but other unknown factors may have a role.

Elizabeth Williamson, professor of biostatistics and health data science, at LSHTM, said: “Normally you take a large amount of people and randomly assign them to one thing, and the other half to another thing, and then compare outcomes.

“Because you’re comparing two completely different sets of people you need more people to take account of.

“Whereas with the n-of-1 design, you’re comparing outcomes within the same person, everything about that person remains the same apart from the treatment you’re giving them.

“And that gives you enormous statistical power – or ability to detect changes. And that’s why you can get valid results with much fewer participants.”

NHS recommendations say millions of people who have not suffered a heart attack or stroke should take statins as a preventative measure.

Statins, which cost pennies each, work by lowering harmful cholesterol in the blood.

Low-density lipoprotein (LDL) cholesterol can lead to a build-up of fatty plaque in the arteries, which can cause blockages and lead to heart disease and stroke.

The National Institute for Health and Care Excellence (Nice) recommends that statins be offered to people whose 10-year risk of cardiovascular disease, including heart attack and stroke, is greater than 10%.

This individual risk is worked out using factors such as ethnicity and social background, and whether the person smokes or has diabetes.

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