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NICE pushes through decision to widen statin treatment to millions more healthy people

NICE advisors have stuck to their decision to halve the risk threshold for primary prevention of cardiovascular disease to 10%, despite calls from the BMA and other clinical experts to drop the proposal because of concerns it will lead to over-treatment.

The final guidance on lipid modification published today could potentially put millions more people on statins and has been criticised by the GPC as having ‘insufficient evidence’ for GPs to have confidence in the recommendation.

NICE has strengthened recommendations on lifestyle changes that should be tried before starting patients on a statin, saying GPs should offer statin treatment ‘if lifestyle modification is ineffective or inappropriate’.

But the final guidance is otherwise largely unchanged from the original draft publication announced in February this year, despite months of controversy.

The major new recommendations are to use the QRISK2 tool exclusively to formally risk assess adult patients up to the age of 84, and to offer high-intensity statin treatment with atorvastatin to patients with a 10-year risk of 10% or higher.

The guidelines state: ‘Before offering statin treatment for primary prevention, discuss the benefits of lifestyle modification and optimise the management of all other modifiable cardiovascular disease risk factors if possible… If lifestyle modification is ineffective or inappropriate offer statin treatment after risk assessment.

‘Offer atorvastatin 20mg for the primary prevention of cardiovascular disease to people who have a 10% or greater risk of developing cardiovascular disease. Estimate the level of risk using the QRISK2 assessment tool.’

Guidelines group chair Dr Anthony Wierzbicki, honorary reader at Guy’s and St Thomas’ Hospital, told Pulse that BMA concerns over the evidence base for statin treatment at the 10% threshold were baseless.

Speaking to Pulse, Dr Wierzbicki said: ‘The evidence is clearly there and even at the relatively conservative risk threshold of 10% for “hard” cardiovascular outcomes, we still show this [approach] is going to be “event-effective” in terms of the best use of resources in the NHS, and it’s also cost-effective in terms of how much money we would have to spend in the NHS to deliver those outcomes.’

Dr Wierzbicki added: ‘There is actually very good disclosure on safety data on statin trials.  We used a huge meta-analysis of  all the phase three data comprising over 300,000 patients – this is all statins, at all doses – published within the last year, which is an enormous trial database of the randomised trials against placebo.’

‘We also have data from registries – although it is always of more limited quality – and prescribing data from various countries, on the rates of side effects and these are really quite low.’

NICE advisors also dismissed the GPC’s objection that GPs would be overwhelmed by the huge increase in appointments needed to manage more patients on statins, arguing that the new recommendations have vastly simplified the approach to managing treatment with lipid-lowering therapy.

Dr Wierzbicki said: ‘We have actually taken a lot of notice of that – and what we’ve done with this guideline is simplified the protocols.’

But the GPC hit back, re-stating its concerns that NICE is ignoring the potential increased risks of harm from statin use and over-estimating the benefits from the evidence so far.

In a collective statement, GPC members wrote: ‘The GPC believe that there is insufficient evidence of significant overall benefit to low-risk individuals to allow GPs to have confidence in the recommendation to reduce the risk threshold for prescribing cholesterol lowering drugs, and that doing so might distort health spending priorities.’

Dr Martin Brunet, a GP in Guilford, Surrey, who has campaigned on over-treatment issues, told Pulse he was ‘extremely disappointed’ that the guidelines group had not given GPs more room to give patients choice on whether to start a statin.

Dr Brunet said: ‘It is so disappointing to see the lack of emphasis on patient preference in the key points summary. There is mention that a lower dose of statin might be used in patients with established cardiovascular disease on the grounds of patient preference, but there is nothing about patient preference in the area of the key recommendation with regards to a CVD risk of 10%.’

Dr Brunet also questioned the push to treat patients with CKD stage 3 with statins.

He said: ‘They now advise not to use any risk stratification, but just to start a statin in all patients with CKD. This will include a huge number of older women who are otherwise well and have what many would consider to be normally ageing kidneys.’

‘For me this is a very significant shift in favour of more treatment.’

NICE Guidelines CG181 - Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease

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Readers' comments (8)

  • We are increasingly tired of NICE and their tunnel vision and remedial understanding of General Practice. How can you explain what happens on the ground to people who almost never see any real patients?

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  • David Bush

    This new recommendation, and the justification given for it by Dr Wierzbicki, demonstrates that NICE have now completely shifted their position from recommending treatments that are beneficial for patients to manipulating populations in order to minimise cost to the State. We should therefore see this recommendation as one aimed at health economists, and of little value to us as clinicians treating individuals patients.

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  • Vinci Ho

    (1) the implication on us is , of course, more statin 'offer' but offer does not necessarily mean 'offer taken' or 'offer tolerated'
    (2) have to engage your patient and ensure that they understand fully the meaning of 10% CVD risk as well as the concept of benefit against risk. We are not living in a perfect world, my dear academic colleagues
    (3) we still need a proper and sensible debate about the exact incidence and prevalence of adverse reactions/side effects , 5-10% or 10-15%? That has to be an official information given to our patients.
    (4) I would predict the Read Code 'Adverse reaction to statin prophylaxis' and equivalents will have to be used more. In fact, also document whether the quality of life of the patient is impaired by statin or not, bearing in mind it means differently in different age group.
    (5) Time , of course , more appointments, you know what I am going to say anyway.
    (6)Remember shared decision with your patients is a task based on democracy , not some autocratic parenting in this Stalinisation, sorry I mean Statinisation.

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  • It's time to put statins in the local water supply! Crazy over treatment. For what purpose?The long term impact of such a policy is a medium term saving but long term expense if costs are looked at. If you look at people/customers/patients then you are looking at increasing chronic health disease costs as people will be living longer with other conditions far harder and costly to manage. These patients will have poor life quality. For goodness sake, the one certainty in life is death. This is not preventable, end of. The focus should be on life quality not quantity. The focus of what modern medicine is trying to achieve should be looked at. Life at all costs is not in anyone's interest. In addition. Primary care does not have the capacity to assess risk and treat what will probably be a significant proportion of the population. Neither should we be responsible for dealing with problems and side effects of this banal policy. This should be a public health problem not primary care.

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  • I participated in an international trial of 'Lipobay' - a statin produced by German company 'Bayer'- around 1999. This resulted in the statin being taken off the market altogether and the Bayer stocks go tumbling on the stock exchanges. Statins can kill - if somebody in NICE has not considered this - not very nice. Let's not medicalize every single bit of our lives. Else we'll have to switch to medicines instead of food much to the glee of the pharma giants.

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  • 2 things worry me about these latest guidelines:

    1.The guidelines advise that anyone aged 85 or over should be considered for statins purely on the basis of their age

    2.All patients with CKD stage 3 or less (eGFR < 60 and /or albuminuria) should now be on statins for primary CVD prevention.

    In other words a huge chunk of our population.And where are the good quality prospective trials to back these claims?There aren't any!

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  • This guidance places GPs in a difficult ethical position if there are no new resources. Each case will mean probably another 2 to 3 appointments per year on a lot of people we wouldn't otherwise see. People who are or think they are unwell already have a difficult time getting appointments. Taking on this work will choke off the likelihood of them actually getting an appointment at all. So - unethical and therefore should not be touched as per GMC Good Medical Practice (unless properly resourced).

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  • Vinci Ho

    In our society , those with the best knowledge of what is happening are those who are furthest from seeing the world as it is.
    1984 , George Orwell

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