Draft updated guidance from NICE published today (12 January 2023) recommends that the risk threshold at which statins should be offered to prevent cardiovascular events such as heart disease and strokes remains unchanged, but they can also now be considered for people at a lower threshold.
Up until now people with a 10% or higher risk over 10 years of a cardiovascular event should be offered a statin under current NICE guidance.
That is set to change after the independent committee updating the NICE guideline on cardiovascular disease (CVD) risk assessment and reduction considered new evidence on the side effects and safety of statins, meaning more people could be given them.
Although statins can sometimes cause side effects such as muscle pains, the best evidence shows that most people don’t get muscle pains with statins, and many more people will get muscle pains whether they take statins or not than have muscle pain caused by statins.
The draft guideline recommends statins can now be considered as part of shared decision-making for people who haven’t had a CVD event (called ‘primary prevention’) with a 10-year CVD risk score of less than 10%. The committee agreed that if more people took statins there would be a greater reduction in the incidence of heart disease and strokes.
The draft guideline recommends that doctors consider atorvastatin 20 mg for the primary prevention of CVD for people with a 10-year risk of less than 10% where the person is happy to take a statin or there is concern that the person’s risk of a cardiovascular event may be underestimated.
CVD is the leading cause of death worldwide, and high cholesterol is a significant risk factor for it. It causes a third of all ischaemic heart disease (where the blood vessels supplying the heart are narrowed or blocked), and contributes in many other cases. In England, high cholesterol leads to over 7% of all deaths and affects up to 60% of adults.
People can be at risk from CVD because of factors they cannot change including their age, sex, ethnicity and family history. The draft guidance continues to recommend that risk factors which can be addressed should be managed. These include stopping smoking, reducing alcohol consumption, taking exercise and eating a healthy diet.
Paul Chrisp, director of the Centre for Guidelines at NICE, said: “What we’re saying is that, for people with a less than 10% risk over 10 years of a first heart attack or stroke, the decision to take a statin should be left to individual patients after an informed discussion of benefits and risks.
“The evidence is clear, in our view, that for people with a risk of 10% or less over 10 years, statins are an appropriate choice to reduce that risk.
“We are not advocating that statins are used alone. The draft guideline continues to say that it is only if lifestyle changes on their own are not sufficient, and that other risk factors such as hypertension are also managed, that people who are still at risk can be offered the opportunity to use a statin, if they want to. They don’t have to, and their decision should be informed by an understanding of the risks and tailored to their values and priorities.”
NICE estimates that under this new recommendation, on average, for every 1,000 people with a risk of 5% over the next 10 years who take a statin, about 20 people will not get heart disease or have a stroke because they take a statin. This figure doubles to 40 for people with a risk of 10%, and for people with a risk of 20% NICE estimates that, on average, around 70 people would not get heart disease or have a stroke in the next 10 years.
With National audit data suggesting that 56% of people with a risk score of 20% or more take statins, compared with less than 50% for people with scores between 10% and 20%, the committee agreed that focusing on increasing uptake among people with the highest risk of CVD events would have more impact. For this reason, the draft guidance says people with a lower than 10% risk can be considered for statin therapy while people at a higher risk should continue to be offered statins. NICE uses ‘consider’ recommendations when there is a closer balance between benefits and harms of an intervention that could be used.