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.’