NICE publishes new draft guidelines on statins use

"Millions more people should be put on cholesterol-lowering statin drugs," BBC News reports. Draft guidance from the National Institute for Health and Care Excellence (NICE) has recommended that the drugs should be given to people with an estimated 1 in 10 or more risk of cardiovascular disease (CVD), which includes conditions such as heart disease and stroke.

Statins are medicines that can help lower rates of low-density lipoprotein (LDL) cholesterol (so-called "bad" cholesterol) in the blood. High rates of LDL cholesterol can lead to hardening of the arteries, a risk factor for CVDs.

At present, guidance for doctors on using statins to prevent CVD says that only people with a 20% or greater risk of developing CVD in the next 10 years should be offered the drugs.

The new guidance recommends lowering the risk threshold so statins are offered to people with a 10% chance of developing CVD. The draft guidance also recommends which assessment tool GPs should use to determine this risk.

NICE recommends that a specific statin called atorvastatin is used for both the prevention and treatment of CVD.

What are statins and who currently takes them?

Statins are medicines that lower the rates of low-density lipoprotein (LDL) cholesterol in the blood.

Increased levels of LDL cholesterol are potentially dangerous, as this can lead to hardening of the arteries, a risk factor for heart attacks and stroke.

Statin treatment is usually recommended for certain groups:

  • people with pre-existing heart disease
  • people who have a high cholesterol level as a result of a faulty gene they have inherited from their parents – this is known as familial hypercholesterolaemia
  • people who are healthy, but have a high risk of developing heart disease at a later date – the current risk threshold is 20%

What are the main recommendations of the draft guidelines?

The main new recommendations on the use of statins to prevent cardiovascular disease are summarised below:

  • Doctors should use the risk assessment tool QRISK2 to assess patients' risk of developing CVD. NICE says this tool is more accurate than other methods, particularly in ethnic populations.
  • Before starting therapy with statins, doctors should take a full lipid profile of the patient. This should include measuring total cholesterol, HDL ("good") cholesterol and non-HDL cholesterol, as well as levels of other fats called triglycerides. The main difference from current guidance here is that a fasting sample is no longer needed.
  • Doctors should offer "high-intensity" treatment with statins to healthy people who have a 10% or greater 10-year risk of developing CVD. "High-intensity" statins produce the largest LDL reduction at the lowest doses.
  • Healthy patients at risk of CVD should be offered 20mg of a drug called atorvastatin to cut the risk of CVD. In the previous guidelines, therapy was started using 40mg of a drug called simvastatin. Atorvastatin is a high-intensity drug, while simvastatin is medium intensity.
  • The draft also says that the decision on whether healthy patients should be prescribed statins should take patient preference into account, as well as other factors such as risks and benefits.

Where do the draft guidelines come from?

The updated draft guidelines have been published by NICE, the National Institute for Health and Care Excellence. They are a draft update of the guidelines on lowering cholesterol (or lipid modification) that were published in 2008.

These are draft guidelines that have been published for consultation with professional and government organisations, patient and carer groups, and companies. These stakeholders have until March 26 2014 to comment before NICE decides on its final recommendations.

Anyone who wishes to comment on the guidelines must first register as a stakeholder. To find out more, visit the NICE consultation page.

What is the rationale behind the new recommendations?

The recommended changes have been made on the basis of cost effectiveness. For example, NICE concluded that high-intensity treatment with 20mg atorvastatin is more cost effective than statin treatment using medium-intensity simvastatin.

It also reports that medium-intensity treatment is more cost effective compared with no treatment or low-intensity treatment at all realistic risk levels.

The guideline group decided to change the threshold from 20% risk to 10% risk by taking into account "the uncertainty regarding the frequency of adverse events in routine clinical practice, which may be higher than in clinical trials, the uncertainty around the magnitude of the effectiveness of statins and the accuracy of the QRISK2 tool itself, as well as the base case cost effectiveness results and sensitivity analyses". 

The drugs have become cheaper in recent years, and their effectiveness is well proven, NICE notes.

The organisation has also pointed out that although death rates from CVD have halved since the 1970s and 1980s, CVD is the cause of one in three deaths in the UK. At present, as many as seven million people in the UK are believed to be on statins, at an estimated annual cost of £285 million.

How accurate is the media reporting?

Headlines in some papers, such as the Daily Mail and the Daily Express, presented the draft guidelines as if they were the final recommendations, which is misleading. 

It is also unclear how The Times concluded that most men over 50 and women over 60 are likely to be offered the drugs. At present, it is not known how many people will be offered statins under the new guidelines, but NICE estimates the number could be in the thousands.

Some of the reporting on the guidelines could also be misconstrued as saying that the use of statins would be compulsory, such as the Express' claim that, "Millions more to be given statins to ward off risk of stroke". As with all NHS treatments, statins would only ever been used if a person consents to treatment.

However, most of the reporting of the story was accurate, with some papers including useful comments from experts.

What are the risks of taking statins?

Statins can have side effects, although the most common ones, while a nuisance, are not serious. They include stomach upsetheadache and insomnia. Occasionally, the drugs can cause inflammation and damage to the muscles. Serious side effects, such as jaundice and visual disturbance, are rare.

Statins are not suitable for everyone. For example, they should not be taken if you have severe liver disease or blood tests suggest your liver may not be working properly.

Read more about the side effects of statins.

What can I do to cut the risk of CVD?

Professor Mark Baker, director of the Centre for Clinical Practice at NICE, said: "People with raised cholesterol levels and high blood pressure should reduce the amount of foods containing saturated fat they eat.

"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."

Read more advice about lowering your cholesterol levels

NHS Attribution