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Statins may have fewer side effects than is claimed, meta-analysis finds

BMJ 2014; 348 doi: (Published 14 March 2014) Cite this as: BMJ 2014;348:g2151
  1. Jacqui Wise
  1. 1London

Only a few types of side effect reported from use of statins are genuinely due to the drug itself, as almost all side effects were reported just as often with a placebo, a systematic review of randomised controlled trials has concluded.1

The findings are important, as the NHS in England is considering wider prescribing of statins. Draft guidance from the National Institute for Health and Care Excellence has recommended lowering the risk threshold for starting treatment with statins to prevent cardiovascular disease.2

Researchers from the National Heart and Lung Institute in London carried out a meta-analysis of 29 randomised controlled trials involving 83 880 patients. Overall, the study found serious adverse events among 14.6% of patients receiving statins and 14.9% given a placebo in the primary prevention trials and in 9.9% of those on statins and 11.2% of those on placebo in the secondary prevention trials.

The authors said that evaluation of the efficacy of statins was always based on evidence from randomised controlled trials of the drugs against placebo but that the evaluation of side effects was not. Adverse events listed for statins come from many sources, including observational studies.

Many side effects such as myopathy, fatigue, muscle aches, and rhabdomyolysis have been commonly attributed to statins, but the researchers found that these were no more common among patients taking statins than among those taking a placebo. The withdrawal rate from trials was also similar for statins and placebo, at around 12-15%.

The study, published in the European Journal of Preventive Cardiology, found that only the risk of developing new onset diabetes mellitus was significantly higher in patients taking statins than in those taking a placebo. Across primary and secondary prevention trials, the rate of developing diabetes was 3% with statins and 2.4% with placebo.

In 14 primary prevention trials that involved 46 262 participants, treatment with statins was associated with an increase in the absolute risk of diabetes of 0.5% (95% confidence interval 0.1% to 1%; P=0.012) and with a reduced risk of death by a similar amount (−0.5% (−0.9 to −0.2%); P=0.003). In the 15 secondary prevention randomised controlled trials (37 618 patients) statins reduced deaths by an absolute 1.4% (0.7% to 2.1%; P<0.001). But only one of these trials reported rates of development of diabetes, and it showed no significant effect.

The only significant adverse event recorded in both primary and secondary prevention was asymptomatic liver transaminase elevation, which was 0.4% more frequent with statins across all trials. However, the authors said it was unclear whether this elevation was harmful.

Judith Finegold, clinical research fellow at the National Heart and Lung Institute in London, said, “Most people in the general population, if you repeatedly ask them a detailed questionnaire, will not feel perfectly well in every way on every day. Why should they suddenly feel well when taking a tablet after being warned of possible adverse effects?”

Finegold called on drug regulators to highlight in the long lists of reported side effects those few whose risk was greater than that experienced with placebo. “We believe that patients should be empowered to make their own decisions, but we must first make sure they have top quality, unbiased information,” she said.


Cite this as: BMJ 2014;348:g2151


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