Millions more patients without cardiovascular disease could be placed on statins by GPs, under draft guidance from NICE that reduces the risk threshold for primary prevention with the drugs to 10%.
The guidelines on lipid modification – put out for consultation today – recommend GPs start patients on high-intensity statin treatment if they have a 10% or more risk of CVD in the next 10 years, rather than the previous target of 20%.
The draft guidelines recommend that atorvastatin 20 mg is used as the preferred initial treatment option in patients identified as high risk, replacing simvastatin.
Experts say the move could double the number of patients taking statins – currently seven million people – and would extend treatment to younger patients.
It follows US guidelines on cardiovascular risk assessment – which recommended a statin threshold of 7.5% 10-year CV risk – and came under fire for making a third of the 40-79 CVD-free population eligible for high-intensity statin treatment.
NICE said they had calculated treating people with a 10% predicted risk with atorvastatin 20 mg would be cost-effective when compared with using lower intensity statins or no treatment at all, with a cost per quality-adjusted-life-year gained of £12,000, when compared with simvastatin 20 mg.
The draft guidance recommends: ‘Offer high-intensity statin treatment for the primary prevention of CVD to people who have a 10% or greater 10-year risk of developing CVD.’
NICE advisers also ruled out the introduction of a lifetime risk calculator, which the Joint British Societies are currently developing and are due to recommend in guidelines to be published later this year.
The major rewrite of the lipid modification guideline also outlined other major changes, including:
- Using the QRISK2 risk tool to assess CVD risk for primary prevention, or the UKPDS risk tool in people with type 2 diabetes – the Framingham risk equation is no longer recommended
- Considering switching patients from a low- or medium-intensity statin onto a high-intensity statin at medication review
- Starting statin treatment in people with established CVD with atorvastatin 80 mg
- Considering people aged 85 or older to be at risk because of age alone, rather than 75 or older as previously, because the QRISK2 score goes up to age 85
- Removing the need for fasting bloods –a fasting sample is not needed for non-HDL cholesterol measures
GP cardiovascular medicine experts were split on the guidance, saying that it would be a lot of work for practices as many more patients would now require statin treatment.
Dr Matthew Fay, GPSI in cardiology in Bradford said: ‘In my opinion, anything that makes GPs more aggressive in the treatment of cardiovascular disease has to be a good thing. We’re not aggressive enough, I think we’re too accepting of just “acceptable” blood pressures and cholesterols.’
Dr Terry McCormack, a GP in Whitby and secretary of the British Society of Hypertension said the threshold was low and would result in many more people being treated who may not benefit.
But he added: ‘This means that more people in their 40s and 50s are going to eligible. The thing about the 20% [threshold] is that at a certain age you’re almost guaranteed to be 20% anyway. I’d much rather treat someone in their 50s when they’ve got years to go.’ Read Dr McCormack’s full comments here.
Dr Des Spence, a GP in Glasgow, said NICE had ‘lost its way’ and the move would lead to over-medicalisation of the population.
He said: ‘Why bother with the pretence, statins for all. Cholesterol is no longer a risk factor but now a full blown disease. Champagne corks are popping across the pharma industry with a NICE-endorsed marketing jackpot.’