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12 February 2014

NICE advises much wider use of statins in draft guidance

NICE is recommending that doctors consider many more people to be at risk of heart disease, stroke or peripheral arterial disease. These conditions, collectively known as cardiovascular disease (CVD), cause 1 in 3 of all deaths in the UK.

The National Institute for Health and Care Excellence (NICE) is recommending that doctors consider many more people to be at risk of heart disease, stroke or peripheral arterial disease. These conditions, collectively known as cardiovascular disease (CVD), cause 1 in 3 of all deaths in the UK.

In draft guidance issued for public consultation, NICE is recommending that the threshold for starting preventive treatment of these conditions should be halved from a 20% risk of developing CVD over 10 years to a 10% risk.

NICE is updating its 2008 guideline on the identification of people at risk of CVD and on the use of lipid lowering drugs to reduce that risk.The guideline is being updated in part to allow consideration of new evidence on CVD risk assessment tools and to reflect changes in the price and availability of generic statins.

People can be at risk from CVD because of factors they cannot change including their age, sex, ethnicity, and family history. The draft guidance recommends that risk factors which can be addressed should be managed. These include stopping smoking, reducing alcohol consumption, taking exercise and eating a healthy diet. Once these factors have been addressed, the draft guidance says high intensity statin therapy should be offered.

Although death rates from CVD have halved since the 1970s and ‘80s, it remains the leading cause of death in England and Wales. In 2010, 1 in 3 people died from CVD (180,000 people). Around 80,000 deaths were caused by coronary heart disease and 49,000 were caused by strokes. Long-term ill health caused by cardiovascular disease is increasing. It disproportionately affects people who are socially deprived or have a low income and there are higher rates in the north of England.

As many as 7 million people in the UK are currently believed to take statins, at an estimated annual cost of £285 million.

Cardiovascular disease develops when fatty substances build up in the coronary arteries and narrow them. The deposits (known as atheroma) are made up of lipids (cholesterol and other fats), calcium and fibrous tissue. As people age, the deposits of atheroma can form into plaques, and in some people the arteries in the heart, brain and legs become severely narrowed, and diseased. Depending on where the disease develops, it can be called coronary heart disease (heart), stroke (neck or brain), or peripheral arterial disease (pelvis and legs).

NICE recommends that people are assessed (using the QRISK2 calculator) for their risk of developing cardiovascular disease using measurements including whether or not they smoke, their cholesterol levels, blood pressure, and body mass index. The calculator then provides a percentage risk of developing CVD in the next 10 years.

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE said:

“Smoking, high blood pressure and raised cholesterol levels are big causes of cardiovascular disease, especially in people with more than one of the factors. But the risk is measurable and we can substantially reduce someone's chance of a heart attack, angina, stroke and the other symptoms of cardiovascular disease by tackling the risk factors. People should be encouraged to address any lifestyle factors such as smoking, drinking too much or eating unhealthily. We also recommend that statins are now offered to many more people - the effectiveness of these medicines is now well proven and their cost has fallen.

“We now want to hear views on this draft guidance which recommends that people with a 10% risk of developing CVD within 10 years are offered statins[1]. Doctors will need to make a judgment about the risks to people who have a less than 10% risk of developing CVD and advise them appropriately.

“As well as taking statins, people with raised cholesterol levels and high blood pressure should reduce the amount of foods containing saturated fat they eat (meat, cheese and milk), they should exercise more and control their blood glucose levels by reducing their intake of sugar and by losing weight. They should also stop smoking.”

The guidance also highlights that standard CVD risk scores will underestimate risk in people receiving certain treatments or who have an underlying condition, including:

  • people treated for HIV
  • people with serious mental health problems
  • people taking medicines that can cause dyslipidaemia such as antipsychotic medication, corticosteroids, or immunosuppressant drugs
  • people with stage 1 or 2 chronic kidney disease
  • people with autoimmune disorders such as systemic lupus erythematosus (SLE), rheumatoid arthritis and other systemic inflammatory disorders.

The draft update of the lipid modification clinical guideline is available to view on the NICE website. As with all clinical guideline consultations, only registered stakeholders such as professional and government organisations, patient and carer groups and companies can comment formally on the draft. However, organisations can register as a stakeholder at any time during the development of a guideline. Registered stakeholders have until 26 March 2014 to submit their comments.


Notes to Editors

About the draft guideline

1. The draft update of the NICE clinical guideline on lipid modification will be available from the NICE website from Wednesday 12 February 2014.

2. Draft key recommendations in the guideline are:

  • For the primary prevention of CVD in primary care, use a systematic strategy to identify people aged 40-74 who are likely to be at high risk.
  • Use the QRISK2 risk assessment tool to assess CVD risk for the primary prevention of CVD.
  • Routinely record ethnicity, body mass index and family history of premature cardiovascular disease in medical records.
  • Before starting lipid modification therapy for the primary prevention of CVD, take at least 1 lipid sample to measure a full lipid profile. This should include measurement of total cholesterol, HDL cholesterol, non-HDL cholesterol, and triglyceride concentrations. A fasting sample is not needed.
  • 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. Estimate the level of risk using the QRISK2 assessment tool.
  • Offer statin treatment for the primary prevention of CVD with atorvastatin 20 mg.
  • Start statin treatment in people with established CVD, type 1 diabetes or type 2 diabetes with atorvastatin 80 mg. If any of the following apply use a lower dose of atorvastatin:
    • potential drug interactions
    • risk of adverse effects
    • comorbidities
    • patient preference.

About CVD

3. Of the 180,000 deaths from CVD in 2010, 46,000 occurred before people were aged 75 years, and 70% of those were in men.

4. Death rates from CVD peaked in the 1970s and 1980s but have since been falling and have now more than halved. Rates have fallen more rapidly in older age groups compared with younger ones with an approximately 50% reduction in the 55-64 year age group compared with a 20% reduction in men aged 35-44 years.

5. In spite of evidence that mortality from CVD is falling, morbidity appears to be rising. CVD has significant cost implications and was estimated to cost the NHS in England almost £6,940 million in 2003 rising to £7,880 million in 2010.

6. CVD shows strong age dependence and predominantly affects people over 50 years. Risk factors for CVD include non-modifiable factors such as age, gender, family history of CVD, ethnic background and modifiable risk factors such as smoking, raised blood pressure and cholesterol.

7. CVD is strongly associated with low income and social deprivation and shows a North-South divide with higher rates in the north of England.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provideare value for money, in order to reduce inequalities and variation.

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[1]People with diabetes or chronic kidney disease should be assessed differently. See the draft guideline for further information.

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