NICE sticks to decision to offer statins to millions more people
Plans to recommend a 10-year risk threshold of 10% for primary prevention of cardiovascular disease will go ahead, despite being hotly disputed. Caroline Price reports
This is despite concerns from the BMA and other clinical experts that it will lead to over-treatment of healthy people.
The final guidance on lipid modification, published last month, could put millions more people on statins and has been criticised by the GPC as having ‘insufficient evidence’ to give GPs confidence in the recommendation.
In response to criticism, NICE has strengthened recommendations on lifestyle changes that should be tried before starting a statin, saying GPs should only offer the drugs ‘if lifestyle modification is ineffective or inappropriate’.
But the final guidance is otherwise largely unchanged from the original draft published in February.
The crux of the debate surrounds the recommendation that GPs should ‘systematically’ assess all adults and offer high-intensity statin treatment with atorvastatin to those with a 10-year risk of 10% or greater.
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.’
NICE says around 4-4.5 million additional people will be classed as ‘high risk’ with the new threshold, of whom only about half will actually start taking a statin as a result.
But it says the evidence shows treatment of this group for three years could prevent 4,000 deaths from cardiovascular disease, 8,000 non-fatal strokes and 14,000 non-fatal MIs.
Guidelines group chair Dr Anthony Wierzbicki, honorary reader at Guy’s and St Thomas’ Hospital, says BMA concerns over the evidence base are groundless.
Speaking to Pulse, Dr Wierzbicki says: ‘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.’
He adds: ‘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 advisers also dismiss the GPC’s objection that GPs will be overwhelmed by the huge increase in appointments needed to manage more patients on statins. The RCGP also raised concerns about over-treatment, which it said should be managed through publicity and communication.
But Professor Mark Baker, director of the centre for clinical practice at NICE, says this is ‘not really justified’.
He says: ‘We’re not suggesting there is a big campaign to get all these people on statins, we’re saying it should be opportunistic. Most of these people, if not all, should be under periodic surveillance by their GP for assessment of cardiac risk, and we will just see consideration of this guidance as part of that process.’
NICE also says practices can now base decisions on non-fasting blood lipid tests, while much of the creatine kinase and liver function monitoring has been dropped.
But the GPC has restated its concerns. In a statement, it says: ‘The GPC believes 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.’
It also claims the move will result in more time spent on low-risk patients, leaving GPs less time for those in greater health need.
The statement says: ‘NICE has not had access to all trial data, having instead only made an assessment of the likelihood of unseen data affecting their conclusions; the studies referenced show no benefits assessed by NICE itself as being too small to be of clinical importance; and that in low-risk patients, drug treatment has not been shown to reduce mortality significantly.’
Many GPs agree. A Pulse survey earlier in the year found more than half would not take a statin at the 10% level, or recommend that family members or friends do so.
What are the main recommendations?
• Use the QRISK2 risk tool to ‘systematically’ assess CVD risk for primary prevention in all patients aged 40 to 84 years. The Framingham tool is no longer recommended.
• Statins should be prescribed only ‘if lifestyle modification is ineffective or inappropriate’.
• Offer 20mg atorvastatin to all patients aged 40 years or over with a ≥10% 10-year risk of CVD.
• Start statin treatment in people with established CVD with atorvastatin 80mg.
• Consider 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.
• No need for fasting bloods for non-HDL cholesterol measures.
‘Sceptical patients will mean this has little impact’
Many GPs will have a sense of the meagre benefits of treatment at the 10% level of cardiovascular risk, as well as the increasing workload, poor rates of uptake and increasing waits for appointments. Only time will tell how many GPs will embrace the guidance.
Analysis of data published within a Lancet meta-analysis suggests that if there is a benefit at all, the number needed to treat (NNT) to prevent one death over five years could be the order of 1,000-2,000 patients – very high by conventional standards.1 So for patients within the new catchment population of 10%-20%, it’s doubtful there is any mortality benefit at all.
For major CV events, the NNT decreases to around 216 (216 patients with a 10%-20% risk would need to be treated annually to prevent one major event) but most of this benefit would be between 15%-20%.
We GPs already routinely use drugs for treating common conditions that have no mortality benefit. However, the difference is that the morbidity from not treating diabetes is not the same not treating cardiovascular risk, the latter being only hypothetical.
There is some good news. NICE has dispensed with the need for serial cholesterol measurements by recommending the reporting of non-HDL cholesterol, a major improvement for clinical practice.
Another advance in the guidelines is recommending fixed doses of statins, notably atorvastatin 20mg, removing any need for titrating treatment.
But despite much research on patient preference in cardiovascular prevention, NICE has not considered it. We know patients are much more sceptical than doctors and need much greater benefits to be convinced.
The pragmatism and scepticism of patients and GPs mean this recommendation will probably have a very slight impact in practice.
Dr Rubin Minhas was a member of the 2008 NICE guideline group on lipid modification and is a GP in Gillingham, Kent.
1. Cholesterol Treatment Trialists’ Collaborators. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012;380:581-590