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Should statins be prescribed for even more people as new NICE guidelines say, or do the risks and costs outweigh the benefits?

UNTIL 2005, STATINS were only prescribed to people with at least a 30 per cent or greater risk of developing cardiovascular disease (CVD) within 10 years (later reduced to a 20 per cent risk). Now new NICE guidelines say the threshold for starting preventative treatment should be halved to a 10 per cent risk – which could mean many more men and women of middle age are offered statin treatment.

According to NICE, one in three (180,000) deaths in the UK are caused by CVD each year, which also has a significant burden of disability. The NHS spends up to £8bn treating CVD. The new guidelines will mean up to 4.5m people could be eligible for statins under the lower threshold, which could help to prevent up to 28,000 heart attacks and 16,000 strokes each year.

NICE advises that people are assessed using the QRISK2 assessment tool, which uses measurements such as smoking status, cholesterol levels, blood pressure and body mass index. The calculator then provides a percentage risk of developing CVD in the next 10 years.

If found to be in the at-risk group, NICE recommends GPs start statin treatment for the primary prevention of CVD with atorvastatin 20mg. Patients with established CVD, type 1 or type 2 diabetes should be offered an 80mg dose of the same drug.

Greater clarity

According to Dr Anthony Wierzbicki from Guy’s and St Thomas’ Hospitals, London, and chair of the guideline development group, the new guidelines give greater clarity, a simpler framework and a systematic way of identifying people who could benefit from treatment.

“We’ve got the best evidence base, huge numbers and the biggest set of clinical trials ever done. Statins work, they are very cheap, and are becoming considerably cheaper as they come off patent, which in a cost-limited health service is a big consideration to think about.”

Other health professionals (but certainly not all; it remains a controversial issue) have broadly welcomed the new guidelines, with the general consensus being that it is good news that more people will now have access to potentially life-saving drugs – rather than agreeing that everyone should be given statins – but with the caveat that other lifestyle factors should also be addressed prior to treatment.

“When it comes to preventing CVD all of us are at risk to some extent, but this doesn’t make giving statins to everyone over 40 years – even those with a 10 per cent risk – a good idea because what needs to be taken into account is what is ‘enough’ of a risk,” says Dr John Reckless, honorary consultant physician and endocrinologist at Royal United Hospital Bath NHS Trust.

“NICE is trying to target people with some ‘significant risk’ of CVD, but all patients should be encouraged to address their relevant risk factors, such as diet and lifestyle, to make sure these are all as good as they could be before going down the statins route. We have an epidemic of CVD we need to get to grips with, but the best way to begin this is by focusing on reducing weight, stopping smoking, and improving diet and exercise levels.”

“I welcome the revised guidance from NICE which recommends robust risk assessment for all patients and an informed discussion about the benefits and risks of therapy at the time a statin is offered alongside lifestyle advice,” says Helen Williams, consultant pharmacist for cardiovascular disease at NHS Southwark Clinical Commissioning Group.

“However the decision has been controversial, with many criticising the strategy for a number of reasons, most notably concerns over the effectiveness of statins in lower risk individuals versus the risk of side-effects.”

According to Ms Williams, the debate is only relevant to statins in the setting of primary prevention (i.e. for people at risk of developing CVD). “In secondary prevention, for people with established CVD, such as angina, prior myocardial infarction, stroke, peripheral arterial disease, the role of statins is indisputable,” she says. “If individuals prescribed statins for secondary prevention raise concerns regarding their value, they should be reassured that they will benefit from statin treatment and advised to continue with their drug therapy.”

Statins work, they are very cheap, and are becoming considerably cheaper as they come off patent

 

Side-effects worries

When it comes to statin side-effects, in particular myalgia (muscle pain), which is relatively common, patients should be advised to seek help where it does occur, she says. “Fear of side-effects such as muscle pain is not a reason to avoid statin use. Patients should be reassured that while side-effects can occur, most people do not experience them. Where they do occur, the GP or pharmacist can give advice on how they should be dealt with.

“Myalgia can be managed by trying a different statin, particularly a water soluble agent such as pravastatin. If myalgia is persistent, then statin withdrawal should be considered for patients treated for primary prevention. Very few individuals experience the more serious myopathy – which will require withdrawal of statin therapy.”

More pharmacy intervention to help people at risk of CVD make healthier lifestyle changes is advocated by Mimi Lau, Numark’s director of pharmacy services. “Prescribing a statin is one way of addressing the problem, but the NHS needs to do more to educate and encourage a population which is ‘growing’ in size – literally as well as in number,” she says.

“These messages can be reinforced by offering services such as weight management and alcohol awareness. Pharmacy can also help by stocking products that promote a healthy lifestyle. Many pharmacies can get involved with blood pressure checks, diabetes screening and cholesterol checks, either as a NHS commissioned service or as a private service and provide these to customers as part of an added value offer.”

Preventative steps

Statins are only part of the strategy to reduce CVD, and because not everyone with a 10 per cent or greater risk of CVD within 10 years will need to take a statin, the NICE guidelines advise that preventative lifestyle measures are adopted first – including addressing smoking cessation, poor diet, obesity and lack of physical activity.

For customers worried about their risk of developing CVD, Dr Reckless recommends taking them through the CVD risk calculating tool on the Joint British Societies website (www.jbs3risk.com/pages/risk_calculator.htm).

“If patients are concerned that they ought to be taking statins, they should talk to their GP,” adds Dr Reckless, “but in the meantime pharmacists can help them find out their risk factor with this calculator, as well as encouraging them to make use of the smoking cessation, blood pressure and cholesterol monitoring and weight management services that your pharmacy may offer.”

A lot of people have no idea what their blood pressure, cholesterol and BMI stats are, so it’s important they know that pharmacy is the place to go to either buy a self-diagnostic test or be tested and have their test results properly explained.

Before considering statins, people who are overweight or have raised cholesterol levels and high blood pressure should:

• Reduce the amount of foods they eat containing saturated fat

• Exercise more

• Control their blood glucose levels by reducing their sugar intake

• Lose weight

• Stop smoking

Research suggests that the reason so many people are becoming overweight and obese is due to inactive lifestyles and unhealthy eating habits but it can be tricky raising the issue with customers if they are not asking for help themselves. Pharmacists might be able to highlight problems associated with excess weight during a MUR, and could do the same if someone is asking for advice about aching joints or shortness of breath, for example. But otherwise it is rather a delicate subject to bring up.

If your customer seems ready to make appropriate lifestyle changes, then an initial assessment of BMI, waist circumference and blood pressure will highlight the need for them to think about weight management strategies. Reassure them that even a small reduction of just five to 10 per cent of their body weight can have considerable health and well-being benefits.