As many as 15 million more people could be eligible for cholesterol-lowering statins to protect them against heart attacks and strokes, according to draft guidelines for the NHS in England.
The National Institute for Health and Care Excellence says the scope for those who can be considered for the drugs should be widened dramatically – in what would be the single biggest change in a decade – to save thousands more lives.
Cardiovascular disease is the leading cause of death worldwide, killing nearly 18 million people a year. In England, high cholesterol causes 7% of deaths and affects up to 60% of adults.
Existing Nice guidance, covering about 10 million people in England, states that those with a 10% or higher risk over 10 years of a cardiovascular event, such as a heart attack or stroke, should be offered statins.
Now statins could also be considered as an option for people with even a small risk. The huge potential change comes after Nice considered new evidence on the side-effects and safety of statins, meaning a wider group of people could be given them.
The Guardian understands about 15 million people aged between 25 and 84 are deemed to have a small risk of a cardiovascular event in the next 10 years. It means about 25 million people in England could become eligible for statins.
The drugs can sometimes cause side-effects, such as muscle pains. However, Nice says the best evidence shows that most people do not 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.
Paul Chrisp, the 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.”
People can be at risk from cardiovascular disease because of factors they cannot change including their age, sex, ethnicity and family history. The draft guidance continues to recommend that risk factors that can be addressed should be managed. These include stopping smoking, reducing alcohol consumption, taking exercise and eating a healthy diet.
“We are not advocating that statins are used alone,” said Chrisp. “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.
“And it may well be that many people will say that they are happy to accept a risk of having a heart attack or stroke rather than taking statins every day – which is absolutely their prerogative. They just need to know and understand the level of risk – and this in itself can be a complex discussion.
“Put simply, it is the responsibility of GPs to explain the ways in which people can reduce their risk of cardiovascular disease, presenting all the options promoted by the draft guidance, including lifestyle changes, blood pressure control, avoidance of diabetes and cholesterol (lipid) lowering, and allow patients to make their own decisions.”
Chrisp stressed that people who wanted to talk to their GP team about this should do so at their next routine appointment, and “don’t need to take urgent action”.
The draft guideline recommends doctors consider atorvastatin 20mg for people with a 10-year cardiovascular disease event risk of less than 10% where there is patient preference for taking a statin or concern that risk may be underestimated.
The Nice committee agreed that focusing on increasing uptake of statins among people with the highest risk of cardiovascular disease events remained key. For that reason, the draft guidance says that while people at lower risk can be considered for statin therapy, people at a higher risk should continue to be offered statins.
Nice said it used “consider” recommendations when there was a closer balance between benefits and harms of an intervention that could be used.
More than 70 million prescriptions for statins are dispensed in England each year, costing the NHS about £100m. The total healthcare cost of cardiovascular disease in England was estimated to be £7.4bn, Nice said.
Prof Naveed Sattar, a professor of metabolic medicine at the University of Glasgow, said: “I agree statins are well proven to lower cardiovascular outcomes cost effectively at thresholds less than 10% so this new guidance makes sense.
“However, we need also to concentrate more on helping people live healthier lives and not just longer with more diseases. Hence, parallel work to help people improve their lifestyles, walking more, eating better, is needed to maximise health gains.”
