New statins study reignites old row

A new study in the Lancet attempted to calm fears about the side-effects of statins in people at low risk of heart disease – but seems to have reignited a bitter row in the medical establishment about their safety.

The study reviewed available evidence on safety and efficacy of statin therapy, in an effort to help doctors, patients and the public make more informed decisions about their use.

The authors warn that the benefits of statin therapy have been underestimated, and the harms exaggerated, because of a failure to acknowledge properly both the wealth of evidence from randomised trials and the limitations of other types of studies.

Available evidence suggests that for every 10,000 patients receiving atorvastatin 40 mg daily, costing around £2 per month, cardiovascular events would be prevented in 1,000 people with pre-existing disease, and in 500 people at increased risk.

The trade-off would be five cases of myopathy (muscle weakness) per 10,000 patients, leading to rhabdomyolysis (muscle wasting) in one patient if treatment is not stopped.

There would be 5-10 haemorrhagic strokes, 50-100 new cases of diabetes and up to 50-100 cases of symptomatic adverse events, such as muscle pain.

The Lancet study followed two articles in the British Medical Journal in late 2013 – which were later corrected –  that questioned use of statins in healthy people at low risk of heart disease.

These articles were heavily criticised by some statins researchers and prompted a media debate about their potential risks and benefits.

The debate became more heated when authors had to correct a figure that wrongly stated that statin side effects occur in 18-20% of people.

An independent BMJ review later found the articles did not reflect caveats in the observational study that was the source of the data, which stated the rate of side-effects was “nearly 18%”.

A further BMJ study, in June, found that more than 200,000 UK patients may have stopped statin therapy in the six months after the media coverage in late 2013.

Statins row continues

Dr Aseem Malhotra, who is firmly in the anti-statins camp, and author of one of the corrected BMJ articles, told the BBC in a radio interview that there is an “epidemic” of misinformed doctors and misinformed patients. There is biased funding of research, biased reporting in medical journals, and biased reporting in the media.

“This review in the Lancet ticks all those boxes of that epidemic of misinformation.”

But Rory Collins, author of the Lancet study, said the publicly available trial information is reliable.

He told the BBC that according to the data there is “no excess” in terms of muscle symptoms side-effects in people taking statins compared with placebo on the trials.

Patients taking statins are aware of the muscle-wasting problem and could be over-sensitive to it, leading to over-reporting that confound the results, Collins said.

He told the BBC: “It is understandable many more people who are taking the drug will report the muscle problem.”

Fiona Godlee editor-in-chief of the BMJ, told the BBC that the evidence suggested statins were most beneficial to patients at high risk of cardiac events.

The latest Lancet article is an attempt to “shut down debate”, Godlee said – but it appears that this is an argument that will continue to divide doctors.

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