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Why we need better information on the side-effects of statins

In a response to an editorial published in the BMJ by Dr Fiona Godlee, I discuss the need for better information to be available on the side-effects of statins. This is a a key issue in the debate about trying to widen the use of statins because of the discordance between rates of side-effects of statins in clinical trials and in clinical practice.

In clinical trials, the incidence of side effects from statins is low and similar in the intervention and placebo groups.[1] In contrast, observational studies using primary care databases report a much higher rate of potentially serious side effects (such as myopathy and renal failure) in people taking statins.[2, 3] Even these rates derived from clinical records may under-estimate the true incidence of side effects in people taking statins because not all patients with side effects will inform their doctor and not all doctors will enter a relevant diagnostic code in the patient’s electronic medical record.

Many general practitioners will be familiar with patients who report that they have experienced side effects after starting statins. These side effects are often severe enough for patients to stop taking statins. Of course, it is possible that the side effects that patients experience after starting statins are either coincidental or psychosomatic and nothing to do with their statin therapy. It is also possible that previous clinical trials (most of which were carried out many years ago) under-recorded the side effects of statins.

Statins are highly effective in lowering cardiovascular risk and improving clinical outcomes.[4] However, the question of what is the true incidence of side effects in people taking statins needs to be addressed urgently if doctors and patients are to be encouraged to increase their use, particularly in people with lower levels of cardiovascular risk.

You can also read my blog on barriers to increasing the use of statins for the primary prevention of CVD on the BMJ Blogs Site.

References
1. Finegold JA, Manisty CH, Goldacre B, et al. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prev Cardiol. Epub ahead of print 12 March 2014. DOI: 2047487314525531.

2. Molokhia M, McKeigue P, Curcin V, et al. Statin induced myopathy and myalgia: time trend analysis and comparison of risk associated with statin class from 1991–2006. PLoS One 2008;3:e2522.

3. Hippisley-Cox J, Coupland C. Individualising the risks of statins in men and women in England and Wales: population-based cohort study. Heart 2010;96:939-47.

4. Cholesterol Treatment Trialists’ (CTT) Collaborators. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet2012;380:581-90.

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