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NICE CG181 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 (Aug 2008)
NICE TA385 Ezetimibe for the treatment of 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)
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). 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:
The following groups are assumed to be at high risk, therefore do not use a risk assessment tool in:
Primary Prevention: Manage modifiable risk factors and offer lifestyle advice:
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:
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
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:
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.
Total cholesterol greater than 7.5mmol/L or FH of premature CHD (an event before 60 years in an index individual or first degree relative):
TC greater than 9.0mmol/L or non-HDL-C greater than 7.5mmol/L
Triglyceride greater than 20mmol/L
Triglyceride 10-20mmol/L
Triglyceride remaining greater than 10mmol/L
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:
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
If statins are contraindicated, not tolerated, or insufficiently effective, consider other options (see below)
Offer Atorvastatin 20mg for primary prevention of CVD to:
Consider Atorvastatin 20mgfor primary prevention of CVD in:
BNF states that the starting dose of 20mg once daily is not licensed for the primary prevention of cardiovascular events.
Check non-HDL cholesterol (total cholesterol minus HDL-C) three months after starting atorvastatin. Where patients have not achieved a 40% or greater reduction in non-HDL-C:
Rosuvastatin is a treatment option for patients where all other appropriate statins have been considered and have either been demonstrated to be insufficiently effective, poorly tolerated or contraindicated.
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.
Atorvastatin and rosuvastatin are not licensed for secondary prevention of cardiovascular events.
Rosuvastatin is a treatment option for patients where all other appropriate statins have been considered and have either been demonstrated to be insufficiently effective, poorly tolerated or contraindicated.
Do not routinely offer fibrates, and do not offer nicotinic acid, bile acid sequestrants, or omega-3 fatty acids* for prevention of CVD to any of the following:
Do not offer bile acid sequestrants, fibrates, nicotinic acid compounds, or omega-3 fatty acids* for prevention of CVD, in combination with a statin, for the primary or secondary prevention of CVD.
Do not offer Co-enzyme Q-10 or vitamin D to increase adherence to statin treatment.
*There is no evidence that omega-3 fatty acids help to prevent CVD.
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