A third of adults should take statins, new research suggests
The number of people taking statins should double, according to the author of a landmark report which has found that the drug's side effects have been exaggerated and the treatment prevents 80,000 heart attacks a year.
The study, which looked at 30 years of evidence, today declares the cholesterol-reducing drug safe and says that the reported side effects have "inappropriately dissuaded" people from taking them.
Debate over whether statins are safe or carry the risk of a series of damaging side effects have raged for years.
The controversy surrounding the pills, prescribed to approximately six million people in the UK, may have put thousands of patients’ health at risk as they were scared off the drugs, the report published in The Lancet warns.
Its findings prompted the report's author, from Oxford University, to suggest that the number of patients prescribed statins should in fact double to up to 12 million - meaning one in three of the adult population would be on the drugs.
Leading heart experts hailed the review of 30 years' evidence as proof that the benefits of statins had been repeatedly under-estimated while the chance of side-effects had been exaggerated.
Prof Rory Collins, of the clinical trial service unit at the University of Oxford, said the review of statins showed “the numbers of people who avoid heart attacks and strokes by taking statin therapy are very much larger than the numbers who have side-effects with it”.
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“Consequently there is a serious cost to public health from making misleading claims about high side-effect rates that inappropriately dissuade people from taking statin therapy despite the proven benefits,” he said.
But critics questioned the research study, pointing out that some of the trials into statins had been funded by commercial companies involved in the manufacture of drugs.
One cardiologist also questioned the report's figures, claiming they did not accurately represent the true rate of side effects.
The review found that the risks of a negative reaction to statins are outweighed by the benefits.
It found that if 10,000 patients are treated over five years with statins, just 200 (two per cent) will experience adverse side effects.
In comparison, Prof Collins, the review author, said statins help prevent around 80,000 major cardiovascular events, such as heart attacks or strokes, per year.
The only side effects reliably shown to be caused by statin therapy are myopathy - a type of muscle weakness -, diabetes and haemorrhagic strokes, according to the report.
Other side effects typically associated with statins, such as memory loss, cataracts, kidney injury, liver disease, sleep disturbance, aggression or erectile dysfunction, have not been proven to be linked to the drug.
The review put the exaggeration of side-effects down to too much weight being placed on unreliable evidence from observational studies. It said the results from randomised drugs trials, which are reliable, have not previously been properly acknowledged.
The release follows an intensification in the debate surrounding statins, with some health officials previously calling for an end to widespread prescriptions for the drug.
The National Institute for Health and Care Excellence (NICE) has previously recommended that anyone with a 10 per cent chance of cardiovascular disease within the next decade should be advised to take the medication.
Experts said the report - described as a “one stop shop” for evidence on statins - has been released in a bid to avert a MMR-style public health scare, which saw a decline in the uptake of the vaccine after a report linked it to autism. That research has since been completely discredited.
Richard Horton, editor-in-chief of The Lancet, said the lessons learned by the journal during the MMR scandal needed to be “widely propagated”.
“We saw in a very painful way the consequences of publishing a paper which had a huge impact on confidence in a safe and effective vaccine,” he said.
The review was welcomed by a number of medical professionals. Dr Maureen Baker, chair of the Royal College of GPs, said she hoped the research “reassures patients”.
“In the majority of cases statins are safe and effective drugs but in most cases where adverse side effects are seen, these are reversible by stopping taking statins,” she said.
“As with any new research, it is now important that this study is taken on board as guidelines for healthcare professionals are updated in the best interests of our patients.”
Dr Tim Chico, a reader in cardiovascular medicine at the University of Sheffield, said statins had been “unfairly demonised”.
“This prevents a sensible discussion of the risks and benefits of their use,” he added. “Statins can cause side effects, but the chance of developing these is low, while the effects of suffering the heart attack that a statin might have prevented can be fatal or life-long.”
Dr Aseem Malhotra, a leading cardiologist, told The Daily Telegraph he believed it was “quite clear” that the number of side effects reported by patients is higher than what has been reported in the trials. He pointed to a previous report, which suggested 62 per cent of patients that stop taking statins within a year do so because of perceived side effects.
He added: “There is great concern amongst doctors about the reliability of industry-sponsored trials. In my view they should be seen as marketing until seen otherwise.
“In many ways this review is anti-science and gives the impression of stifling the debate on statins where there remains considerable controversy about side effects.”
Dr June Raine, a director at the Medicines and Healthcare products Regulatory Agency, said any new significant information would be carefully reviewed.
“Medicine safety and effectiveness is of paramount importance and under constant review. Our priority is to ensure that the benefits of medication outweigh the risks," she said.