Statins not to blame for aches – it’s just age

GPS urged to ease patients’ fears as Oxford study finds drugs rarely cause muscle pain

STATINS do not cause common aches and pains – those taking them are simply getting older, research has found.

GPS have been advised to offer patients greater reassurance about the drugs, paving the way for millions more people to be prescribed the cholesterolbusting pills.

Researchers at Oxford University said they had “definitively” debunked the widespread belief that statins are a likely cause of muscle aches.

The “monumental” study found the pills, which are taken by more than eight million people in the UK, cause muscle pain for one in 100 recipients.

While aches are experienced by many taking the drugs, the vast majority of them are caused by other things – most commonly the march of time.

Because most people start taking statins in their later years, many wrongly attribute the creaks of old age to the drugs, scientists said.

The research, published in The Lancet, involved more than 150,000 patients and was the largest study undertaken of statin side-effects. It used random, double-blinded groups to remove any risk of bias.

Charities said the findings, unveiled at the European Society of Cardiology conference in Barcelona, were the “gold standard” of evidence on the matter, and should reassure millions of people.

It follows decades of debate about the merits of statins as many patients come off the drugs, which greatly reduce the risk of heart attacks, because they blame them for their aches and pains.

Researchers last night urged GPS to be far more positive when talking to patients about the drugs, and called for “incredibly misleading” warnings linking them to muscle pain to be rewritten.

About 18million adults in the UK – including almost all men over the age of 60 and women over the age of 65 – are eligible for statins under NHS guidance based on an assessment of heart disease risk. Of those, around eight million take the pills, which cost the health service less than 5p per day.

Prof Sir Nilesh Samani, medical director at the British Heart Foundation, which co-funded the study, said the findings should bring an end to decades of debate.

“This research should help millions more people around the world feel confident in talking to their doctors about taking statins to reduce their risk of deadly heart attacks and strokes,” he said. “This is the definitive study. This is really gold-standard evidence.

“The size of the study gives us enormous confidence.”

The study found that more than a quarter of patients taking the tablets reported muscle aches. But a similar number of those in the placebo group also complained of them.

For every 1,000 people who start taking the drugs, 11 develop muscle aches or weakness as a result, the study found. It showed that statins were to blame for one in 15 cases of such muscle pain. And this disappeared after a year of taking the pills.

Scientists said the symptoms were not in people’s minds – but ordinary aches attributed to the pills.

Patients are often told that statins may cause muscle pain, creating a “nocebo” effect that wrongly blames them for unrelated ills, the study found.

Researchers obtained findings from 23 randomised controlled trials. No one involved knew whether they had been put on a statin or on a placebo.

Some 27.1 per cent of those on statins reported muscle issues – a “tiny” increase on the 26.6 per cent of the group given dummy pills who also said they suffered them.

Prof Colin Baigent, of the University of Oxford, the study’s lead author, said: “There’s no doubt that ageing does increase your risk of experiencing pain and other conditions that are known to cause pain… thyroid disease, arthritis – even something simple like exercise when you’re not particularly fit.”

Prof Baigent said scientists had embarked on a “monumental” study of

thirty years of data in order to settle the matter.

Until now, the debate had been skewed by non-randomised studies that did not include placebos or random allocation, resulting in “quite extreme” estimates that have misled the public.

He said: “This has put patients off starting statins or made them stop treatment when they develop muscle pain.

“Over 90 per cent of the time when a patient taking a statin gets muscle pain it isn’t the statin that’s causing it.

“If we could get people to be better informed about the real risks of muscle pain we can get people to stay on the therapy longer.”

The scientist also said there was a need to revise the information placed in drug packs, to clarify that most muscle pain experienced during statin therapy is not caused by the statins.

The current inserts in drug packets were often “incredibly misleading”, he said.

Researchers said GPS needed to be extremely careful about the way they approached discussing such risks, and should avoid putting too much emphasis on side effects.

Prof Baigent said: “Up until now they thought that keeping patients safe was best served by having these warnings about the possibility of muscle pain.

“What we’ve shown that is not the best way to serve patients because patients take that information and, the moment they develop muscle pain, they suspect the statin.

“That causes many of them to stop

‘If we could get people to be better informed about the risks, we can get people to stay on the therapy longer’

the statin, which actually puts them in harm’s way.”

Prof Martin Marshall, chairman of the Royal College of GPS, said: “This study should be reassuring to clinicians and to patients taking or considering taking statins.

“GPS are highly trained to prescribe and will do so based on the circumstances of individual patients.

“We will take into account a patient’s health needs and their medical history, as well as clinical guidance – and we will consider the various treatment options, not just drug therapies, in conversation with the patient about the risks and benefits of each.”