Intended for healthcare professionals

Views & Reviews From the Frontline

Statins for all

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g1899 (Published 03 March 2014) Cite this as: BMJ 2014;348:g1899
  1. Des Spence, general practitioner, Glasgow
  1. destwo{at}yahoo.co.uk

The UK National Institute for Health and Care Excellence has issued new guidelines on lipid lowering. The headlines are: lower the treatment threshold for primary prevention to people with a 10 year risk of 10%, use atorvastatin preferentially, and use the Qrisk assessment tool.1 This guidance, authored by a small group of important cholesterol specialists, is surely a scientific and thought through analysis of the research data. Shouldn’t we embrace such authoritative advice?

The guidelines rely on a simplistic model of the cause of ischaemic heart disease, assuming that its decline is merely the result of a reduction in risk factors and better medical management.1 But the decline in vascular disease predates medical treatment, and the data are riddled with unexplained paradoxes.2 There is more to vascular disease than lipids, hypertension, and the rest.

The new 10% threshold means that an average man is eligible for treatment at age 56. The health obsessed, thin, middle class man, who doesn’t smoke, is normotensive, and doesn’t have diabetes or a relevant family history fares little better, getting statins at 60.3 It is now statins for all.

But the evidence for treating this low risk group comes from a reworked meta-analysis of old disparate cholesterol studies.4 Shouldn’t we have definitive research before we “statinise” a whole population? And wouldn’t it be meaningful and useful to advise patients of numbers needed to treat for deaths and heart attacks and strokes prevented? In NICE’s worthy, 1000 page document I found none.1 5

At the heart of this guidance is an economic model, made available only after signing a confidentiality agreement. Central to the model is the assumption of a linear link between cholesterol concentration and cardiovascular disease, with lower always better, but this is not always the case.6 Accordingly, NICE recommends atorvastatin because of its few percentage points advantage in lowering cholesterol compared with simvastatin.5 Yet “Evidence Statements” in the document state that “there is no clinical difference between simvastain 20 mg and atorvastatin 80 mg at reducing CV [cardiovascular] mortality,”1 with similar neutral statements for stroke and all cause mortality.1 Is the difference between atorvasatin and simvastatin clinically significant? Why disrupt current practice on limited evidence?

Another important yet overlooked recommendation is the new arbitrary 40% reduction in cholesterol concentration.1 What happens when we miss this target? Doctors will prescribe expensive branded Crestor (rosuvastatin), which has US annual sales of about $5bn (£3bn; €3.6bn).7 Surprisingly (or unsurprisingly), many of NICE’s expert authors have links to big pharma, including AstraZeneca, which makes rosuvastatin.5

What has happened to scepticism, evidence based medicine, and the duty to protect the well? Is NICE any longer fit for purpose?

Notes

Cite this as: BMJ 2014;348:g1899

Footnotes

  • Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.

  • Provenance and peer review: Commissioned; externally peer reviewed.

  • Follow Des Spence on Twitter @des_spence1

References

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