Management of blood lipids

NICE CG 181 recommends that lipid modification therapy should be offered to people whose ten year cardiovascular disease (CVD) risk is 10% or more, as assessed using QRISK2. This means that many more people will be eligible for a statin than have been in the past. It has been demonstrated that it is cost effective to offer high intensity statin therapy for the primary prevention of cardiovascular events people with risk levels down to 10%, partly as a result of the recent significant reductions in acquisition costs of atorvastatin. The changing cost effectiveness of statins means that more people could be treated for primary prevention, but it does not necessarily mean that they must. The decision to offer lipid-lowering therapy must be based on the individual.

In its costing report, NICE acknowledge that expert opinion suggests that there is insufficient capacity within existing primary care resources to meet the increase in demand as a result of implementing the guideline. Over ten years, primary prevention using high intensity statin therapy will prevent an event in 4 out of 100 people at 10% risk but it will prevent an event in 15 people out of 100 at 40% risk. The greatest benefit will be gained by prioritising those at greatest risk. Clinicians are advised therefore to employ a systematic strategy to identify patients at risk but, given the capacity limitations within the primary care setting, prioritise for review those patients at greatest risk.

It is recognised that there is marginal benefit to be gained from switching patients already stabilised on a medium intensity statin, to a high intensity one (e.g. simvastatin 40mg to atorvastatin 20mg). Clinicians should discuss with such patients the likely benefits and potential risks of changing, at their next regular medication review. A change from simvastatin 40mg to atorvastatin 20mg will derive only a modest additional benefit (an average additional 6% reduction in LDL-cholesterol). Simvastatin 40mg remains an evidence based treatment option supported by the Landmark Heart Protection Study in reducing CV events; patients should be reassured that they will still be getting benefit by taking a moderate intensity statin. Patients at higher risk and those currently taking low intensity statin doses should be prioritised for change.

NICE have produced a set of patient decision aids to support discussions about lipid modification therapy and a user guide for health professionals

NICE CG71 Familial hypercholesterolaemia (August 2008)

NICE TA385 Ezetimibe for the treatment if primary (heterozygous-familial and non-familial) hypercholesterolaemia (February 2016)

NICE CG181 Lipid Modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease (July 2014)

Risk Assessment

Prioritise people without CVD for a full risk assessment if their estimated 10 year risk is 10% or more. People aged 40 years or more should have their risk reviewed on an ongoing basis. Frequency of review will depend on the individual's other risk factors (NICE do not specify a frequency). In the absence of other risk factors, the age-related estimated risk remains below 10% until the age of 60 in men and 65 in women.

Use the QRISK2 tool to assess risk for primary prevention in people:

  • Aged up to 84 years, including those with type 2 diabetes.

The following groups are assumed to be at high risk, therefore do not use a risk assessment tool in:

  • people with type 1 diabetes
  • people with eGFR less than 60ml/min/1.73m2l and/or albuminuria
  • people with pre-existing CVD
  • people with family history of familial hyperlipidaemia
  • anyone aged 85 years or over

This guideline recommends the use of non-HDL (i.e. TC-HDL) cholesterol to give the best estimate of CV risk. A fasting sample is therefore not needed.

Initial management

Primary Prevention: Manage modifiable risk factors and offer lifestyle advice:

  • Diet and weight management
    • (n.b. do not advise people to take plant stanols or sterols for CVD prevention if they are being treated for primary or secondary prevention of CVD, or they have type 1 or type 2 diabetes, or CKD)
  • Physical activity
  • Alcohol intake
  • Stopping smoking

If risk is below 10%, use clinical judgement to decide on further treatment of risk factors in people who are below the CVD risk threshold for treatment. Note that CVD risk may be underestimated in the following situations:

  • BMI more than 40kg/m2
  • serious mental health problems
  • currently receiving antihypertensive, or other lipid-modifying treatment
  • currently receiving drugs that cause dyslipidaemia e.g. antipsychotics, corticosteroids, immunosuppressants
  • recent ex-smokers
  • people with HIV
  • people with systemic inflammatory disorders

Offer lipid lowering therapy if CVD risk remains at 10% or more.

Secondary Prevention: Do not delay starting statin therapy to manage modifiable risk factors

Lipid modification therapy: Baseline monitoring and follow-up

Liver enzymes (alanine aminotransferases or aspartate aminotransferase)

Measure liver transaminases (ALT or AST) before starting statin therapy. Do not routinely exclude people with levels raised but less than 3 times ULN.

Measure levels after 3 and 12 months but not again unless clinically indicated. For patients switched from a moderate to a high intensity statin, whose liver transaminase levels were stable previously, local expert opinion does not recommend routinely repeating their LFTs.

Measure Total cholesterol, HDL cholesterol, and non-HDL cholesterol after three months in all people who have been started on a high intensity statin. If 40% reduction in non-HDLc has not been achieved:

  • Discuss compliance and dose timings
  • Optimise diet and lifestyle measures
  • Consider increasing statin dose if commenced on less than 80mg daily atorvastatin and patient at high risk due to co-morbidities, risk score, etc.

Before starting statin therapy, measure Total cholesterol (TC), HDL-C, Non-HDL-C (from total – HDL-C), Triglycerides. A fasting sample is NOT needed. Use clinical findings as well as profile results to assess likelihood of familial lipid disorders.

Action to take if:

Total cholesterol greater than 7.5mmol/L and FH of premature CHD* (defined as CVD in male first-degree relatives under 55 years or female first-degree relatives under 65 years):

  • Consider possibility of familial hypercholesterolemia and investigate as per NICE CG71.

TC greater than 9.0mmol/L or non-HDL-C greater than 7.5mmol/L

  • Arrange for specialist assessment (even in absence of 1st degree FH premature CHD)

Triglyceride greater than 20mmol/L:

  • Refer to specialist (if not due to excess alcohol or poor glycaemic control)

Triglyceride 10-20mmol/L:

  • Repeat with fasting test between 5-14 days later and review for secondary causes of hyperlipidaemia.

Triglyceride remaining greater than 10mmol/L:

  • seek specialist advice

Triglyceride 4.5-9.9mmol/L:

Optimise other risk factors. Note that risk assessment tool may underestimate CVD risk, therefore patients should not be risk scored until review:

  • BMI more than 40kg/m2
  • serious mental health problems
  • currently receiving antihypertensive, or other lipid-modifying treatment
  • currently receiving drugs that cause dyslipidaemia e.g. antipsychotics, corticosteroids, immunosuppressants
  • recent ex-smokers
  • people with HIV
  • people with systemic inflammatory disorders

Creatinine Kinase (CK)

Measure CK levels in people reporting generalised muscle pain before starting a statin.

Do not measure CK levels in asymptomatic people who are being treated with a statin.

If CK more than 5 times ULN: re-measure after 5-7days. If levels remain greater than 5 times ULN, do not start statin

If CK raised but less than 5 times ULN: start statin at a lower dose

Lipid modification therapy: Statins

Primary Prevention:

Atorvastatin 20mg

Offer Atorvastatin 20mg for primary prevention of CVD to:

  • Adults aged up to 84 years with at least 10% CVD risk, including people with type 2 diabetes, assessed using QRISK2.
  • Adults with Type 1 diabetes who
    • are aged over 40 years, or
    • have had diabetes for more than ten years, or
    • have established nephropathy, or
    • have other CVD risk factors
  • Adults with CKD

Consider Atorvastatin 20mg for primary prevention of CVD in:

  • People 85 years and over. It may be of benefit in reducing risk of non-fatal MI. Decisions about interventions should be made on an individual clinical basis.
  • Any other adults with type 1 diabetes

Check non-HDL cholesterol (total cholesterol minus HDL-C) three months after starting high intensity statin. Where patients have not achieved a 40% or greater reduction in non-HDL-C:

  • Discuss dose adherence and timing
  • Reinforce diet and lifestyle measures
  • Consider increasing the dose in patients who were started on less than atorvastatin 80mg daily and are judged to be at higher risk of cardiovascular disease because of co-morbidities or risk score, or using clinical judgement. Note the maximum dose for primary prevention in CKD is 20mg.

Secondary Prevention:

Atorvastatin 80mg

Start atorvastatin in people with CVD. Do not delay treatment to manage modifiable risk factors. Consider a lower dose where there is a risk of interactions, adverse effects or patient preference.

Note the maximum dose for secondary prevention in CKD is Atorvastatin 20mg

 

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