Where’s the evidence that treating younger women with statins will do anyone any good?

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Back in February, the National Institute for Health and Care Excellence (NICE) published draft proposals concerning the use of statins for the prevention of cardiovascular disease. Previously, NICE has advised doctors to recommend treatment in those with a calculated 10-year risk of cardiovascular disease of 20 per cent or more. Now, NICE is proposing that this threshold be reduced to 10 per cent.

As I explained here though, what the evidence shows is that the vast majority of people at relatively low risk of cardiovascular disease are extremely unlikely to benefit from statins, while risk of side-effects (including diabetes, liver damage, kidney damage, fatigue and muscle pain) are relatively high (around 20 per cent). There’s a valid argument that in low-risk individuals, the harms of stains outweigh the benefits, and I think that NICE’s proposals are utterly misguided.

With this background I was interested to read this piece in the Daily Mail earlier this week. It informs me that health charities (including the British Heart Foundation) are proposing that more women, including those in the 40s, be treated with statins. You see, according to the head of the British Heart Foundation, Professor Peter Weissberg, while the 10-year risk of some women “with stonkingly high cholesterol, very high blood pressure and who [smoke] is still fairly low”, “…her lifetime risk is huge.” The implication is that such women should be started on statins nice and early.

When pronouncements such as these are made, I sometimes like to see what evidence there is to support them. So, do we have studies that show that early treatment of women with statins leads to meaningful improvements in health outcomes?

The treating of individuals with no history of cardiovascular disease (such as a previous heart attack or stroke) with statins is an example of what is termed ‘primary prevention’. A previous review of six primary intervention studies found that reducing cholesterol did not reduce the risk of heart disease related events (e.g. heart attacks), death from heart disease or overall risk of death [1]. This evidence does cast some doubt on the wisdom of treating women with no established cardiovascular disease with statins.

But, I suppose, maybe Professor Weissberg will not care much about the research. After all, he is the person to steadfastly refused to engage with the evidence that suggests that cholesterol-reducing sterols (which the BHF recommends) may well have adverse effects on health (you can read more about this here). He is also the person who has previously used evidence to support the use of the statins that simply does not support the use of statins (see here for more about this).

This article also included input from Professor Rory Collins, who tells us that for those treated earlier “[their] potential benefit over the longer term is greater.” Potential is one thing, but how about providing the evidence that demonstrates this potential is realised in terms of actual benefits? ‘Experts’ and ‘scientists’ can pronounce all they like, but should their ideas not be based on actual evidence rather than assumptions?

Perhaps, though, we should not be too surprised that Professor Collins appears to play fast and loose with the evidence. After all, he is one of the research group (the Cholesterol Treatment Trialists) that regularly makes very positive noises about statins and reassurances about their safety based on data that is held close and no-one else is allowed to see. See here for more about this.

There’s a saying that “Extraordinary claims require extraordinary evidence.” I reckon the only extraordinary thing about the likes of Professors Weissberg and Collins is the just how often they appear (perhaps unwittingly) to rely on rhetoric rather than solid, verifiable research.

References:

1. Walsh JME, et al. Drug treatment of hyperlipidemia in women. JAMA 2004;291:2243-52

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