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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

National Guidelines

NICE TA3851

Technology Appraisal 385 was published in February 2016 to replace TA 132

NICE recommends EZETROL for use with statins1

Co-administered with a statin

Ezetimibe is recommended as an option for the treatment of adults with primary hypercholesterolaemia who have been initiated on statin therapy when:

  • Serum TC or LDL-C concentration is not appropriately controlled, either after appropriate dose titration of initial statin therapy, or because dose titration is limited by intolerance to the initial statin therapy and 
  • consideration is being given to changing from initial statin therapy to an alternative statin

NICE CG18122

In July 2014 NICE published an updated Lipid Modification Clinical Guideline, which was named CG181. CG181 guideline replaced CG67, which was retired.

The key recommendations in CG181 are as follows:2

  • For primary prevention use a systematic strategy to identify people who are likely to be a high risk.
  • Prioritise people for full risk assessment if their estimated 10 year risk is 10% or more using the QRISK2 tool.
  • A full lipid profile should be taken before lipid modification therapy is initiated, performed on a non-fasting blood sample.
  • Use atorvastatin 20mg in primary prevention for all those that have a 10 year risk over 10%
  • Atorvastatin 80mg is recommended as the initial treatment dose for patients with established CVD unless:
    • Potential drug interactions exist
    • There is a high risk of adverse events
    • Patient preference
  • The guideline acknowledges that atorvastatin 80mg does not have a license for CVD patients and as such informed consent should be gained before initiation
  • Aim for a greater than 40% reduction in non-HDL cholesterol after 3 months of treatment with high intensity statin
  • Starting dose for CKD patients is atorvastatin 20mg

There are many differences between CG67 and CG1812, the major differences are:

  • Specific targets of <4mmol/L for TC or <2mmol/L for LDL-C are not mentioned
  • Non-HDL cholesterol replaces LDL-C as the biomarker for cholesterol. Non-HDL-C is calculated by the following simple equation
    • Non-HDL = Total Cholesterol - HDL
  • Atorvastatin 80mg is recommended as the first line treatment for secondary prevention

Joint British Societies’ guidelines (JBS3)3

JBS have recently published new guidelines on recommendations for the prevention of cardiovascular disease and the use of lipid lowering treatments.

The full version of the guidelines can be accessed via the following link: http://heart.bmj.com/content/100/Suppl_2/ii1.full

Risk calculator

The main change from the previous version of the guidelines, JBS2, is the focus on lifetime risk. A new JBS3 risk calculator has been developed, based on QRISK lifetime, which allows identification of patients who are at high lifetime risk of CVD. This calculator is based on traditional risk factors that are commonly measured.

Measuring high cholesterol

Non-fasting blood samples should be taken to measure total cholesterol (TC) and HDL-cholesterol. It is expected that non-HDL-C will gradually replace LDL-C in clinical practice as well as in clinical trials. Accumulating evidence indicates that non-HDL-C provides better prediction of risk and treatment response than LDL-C. Non-HDL-C, contains all the known atherogenic lipid fractions, and is calculated from TC minus HDL-C.

High-risk patients – who to treat

Cholesterol-lowering drug therapy is recommended in the following patient types:

  • Patients with established CVD
  • Individuals at particularly high risk of CVD: diabetes, age >40 years, patients with chronic kidney disease stages 3-5, or familial hypercholesterolaemia
  • Individuals with high 10-year CVD risk (threshold to be defined by NICE guidance)
  • Individuals with high lifetime CVD risk estimated from heart age and other JBS3 calculator metrics, in whom lifestyle changes alone are considered insufficient by the physician and person concerned

Guidance on treating patients with high cholesterol

Ezetimibe can be considered in people with statin intolerance, or when a statin alone is not enough:

  • All high-risk people should receive professional lifestyle support to reduce TC and LDL-C, raise HDL-C, and lower triglycerides to reduce their CVD risk
  • Statins are recommended as they are highly effective at reducing CVD events with evidence of benefit to LDL-C levels <2 mmol/L which justifies intensive non-HDL-C lowering
  • Statins should be prescribed with a lower is better approach to achieve non-HDL-C values of at least <2.5 mmol/L equivalent to 1.8 mmol/L for LDL-C
  • If unable to tolerate any statin, or if the cholesterol is considered inadequately controlled on the achieved statin dose, consider the addition of ezetimibe 10 mg daily or bile acid sequestrant

References

  1. National Institute for Health and Care Excellence. Technology Appraisal 385. Ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia. Available at: https://www.nice.org.uk/guidance/ta385 Last accessed December 2016.
  2. National Institute for Health and Care Excellence (NICE). Clinical Guidance (CG) 181: Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. July 2014. Available at: http://www.nice.org.uk/guidance/cg181 Last accessed December 2016.
  3. Joint British Societies’ consensus recommendations for the prevention of cardiovascular disease. Deanfield et al. Heart 2014; 100: ii1-ii67.

More information about EZETROL ® (ezetimibe):

Supporting documentation

CARD-1247015-0000 | Date of Preparation: March 2018