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The formulary guidance was developed in consultation with lipid specialists in Devon and is informed by the following resources.
NICE guidelines:
NICE technology appraisals:
These are referenced under the relevant drug entry (see section 2.12 Lipid-regulating drugs).
NHS England/AAC guidance:
Patient decision aids:
NICE has produced a set of patient decision aids to support discussions about lipid modification therapy.
Clinical referral guidance:
Familial hypercholesterolaemia: South Devon; West Devon
Suspect familial hypercholesterolaemia (possible heterozygous FH) if:
Do not use the QRISK assessment tool, follow the guidance under “Familial Hyperlipidaemia” below.
Greater than 20mmol/L
10 - 20mmol/L
4.5 - 9.9mmol/L
*See additional risk factors listed under the following subsection 'Primary prevention: risk assessment'.
Measure CK if patient has new onset or worsening muscle symptoms which are typical of statin-related muscle toxicity – See 'Statin Intolerance below
Offer statin to:
Consider statin for:
*These are the only circumstances when the QRISK tool should be used to assess cardiovascular risk.
Do not use the QRISK tool for those who are at high risk of developing CVD because of familial hypercholesterolaemia or other inherited disorders of lipid metabolism. See 'Familial hypercholesterolaemia' below.
Standard CVD risk scores including QRISK may underestimate risk in people who have additional risk because of underlying medical conditions or treatments, including the following groups of people:
Consider socio-economic status as an additional factor contributing to CVD risk
If QRISK < 10% over the next 10 years - Give lifestyle advice and ensure regular review of CVD risk in line with guidance.
For all patients: Identify and address all modifiable risk factors - smoking, diet, obesity, alcohol intake, physical activity, blood pressure and HbA1c. Do not delay starting statin treatment for secondary prevention while addressing these.
Treatment target for primary and secondary prevention: Non-HDL-C reduction > 40% from baseline.
If lifestyle modification is ineffective or inappropriate:
Advise people who are being treated with a statin to seek medical advice if they develop muscle symptoms (pain, tenderness or weakness).
If statin contraindicated: see 'Statin treatment contraindicated or statins not tolerated' below for further options.
Offer statin therapy to adults with CVD:
Offer Atorvastatin 80mg once daily (see section 2.12 Lipid-regulating drugs)
Measure non-fasting lipid profile again after 3 months.
High intensity statin treatment should achieve > 40% reduction in non-HDL-C from baseline. If not achieved after 3 months:
If side effects on a high-intensity statin, offer a lower dose or an alternative statin:
Therapy with a low dose statin is preferred to no statin.
If maximum tolerated dose of statin does not achieve > 40% reduction in non-HDL-C from baseline:
*In line with NICE TA733, inclisiran may be added to maximally tolerated statin with or without another lipid-lowering therapy if LDL-C remains 2.6mmol/L or more. Local specialists recommend the addition of ezetimibe to a statin before considering inclisiran as ezetimibe is an established drug with evidence from a cardiovascular clinical outcome trial. See below for further information on injectable therapies. Fasting LDL-C test required.
See 'Statin Intolerance' below for advice on adverse effects (therapy with a low dose statin is preferred to no statin).
Consider ezetimibe 10mg once daily as monotherapy (see section 2.12 Lipid-regulating drugs)
Measure non-fasting lipid profile again after 3 months.
If ≤ 40% reduction in non-HDL-C from baseline, consider bempedoic acid 180mg (with ezetimibe 10mg) once daily.
Assess response after 3 months:
The place in therapy for injectable therapies is outlined above when statins are not effective, contra-indicated or not tolerated.
See section 2.12 Lipid-regulating drugs
Refer to specialists for consideration of a PCSK9 inhibitor (alirocumab or evolocumab) in the following circumstances:
OR consider inclisiran if:
Symptoms typical for statin-related muscle toxicity: symmetrical pain and/or weakness in large proximal muscle groups, worsened by exercise. If these are present, measure CK level.
Consider other causes if:
Other possible causes may include musculoskeletal disorders, metabolic, degenerative or inflammatory (e.g. Vitamin D deficiency, polymyalgia rheumatica). Check bone profile, Vitamin D and CRP.
Stop statin, urgently seek specialist advice and inpatient assessment if:
Stop statin, refer for out-patient assessment, if stable renal function and CK ≥ 10x and < 50x ULN
Continue treatment if patient happy to do so and tolerable symptoms, no clinical concern and CK < 5x ULN.
If symptoms not resolved within 6 weeks, stop the statin for 4-6 weeks and follow the guidance on 'Action to take after stopping statin' below.
Stop statin for 4-6 weeks if symptoms typical of statin-related muscle toxicity and:
Follow the guidance on 'Action to take after stopping statin' below.
Action to take after stopping statin (4-6 weeks later):
It is important to note that cardiovascular benefits have not been proven for all the above approaches but any reduction of LDL-C / non-HDL-C is beneficial.
If symptoms appear statin-related, consider de-challenge and re-challenge or change to a different statin (e.g. hydrophilic instead of lipophilic). Atorvastatin and simvastatin are lipophilic statins. Rosuvastatin is a hydrophilic statin.
Clinical referral guidance: South Devon; West Devon
Clinicians may use either the old Simon-Broome criteria or the latest Dutch Lipid Clinical Network (DLCN) criteria which are evidence-based and more accurate than the Simon-Broome criteria to assess patients.
The DLCN criteria are used to diagnose Familial Hypercholesterolaemia based on work from the Netherlands. It relies on a points system, where a set number of points are given to lipid stigmata, personal or family history of premature CVD and LDL-cholesterol levels. A score more than 5 makes the patient probable or definite Familial Hypercholesterolaemia and eligible for genetic testing which is commissioned by NHS England. A score of 5 or less means Familial Hypercholesterolaemia is still possible but less likely and those patients are generally not eligible for genetic testing unless in exceptional circumstance.
Suspect familial hypercholesterolaemia (possible heterozygous FH) if:
Take fasting blood for repeat full lipid profile to measure LDL-C.
Use the Simon Broome criteria or Dutch Lipid Clinic Network (DLCN) criteria to make a clinical diagnosis of FH.
Clinical referral guidance: South Devon; West Devon
Refer the person to a lipid clinic if:
Primary and secondary prevention
Follow the treatment management pathway for primary or secondary prevention above.
Treatment target: Aim to achieve at least a 50% reduction of LDL-C (or non-fasting non-HDL-C) from baseline for primary and secondary prevention
Consider referral to a specialist for further treatment and/or consideration of PCSK9 inhibitor therapy (alirocumab or evolocumab) if:
See section 2.12 Lipid-regulating drugs
There is no evidence that omega-3 fatty acids help to prevent CVD, except use of icosapent ethyl with statin as described in NICE TA805.
Do not offer nicotinic acid or omega-3 fatty acids* alone or combination with a statin for:
This does not apply to icosapent ethyl with statin if used in line with NICE TA805.
Do not offer Co-enzyme Q-10 or vitamin D to increase adherence to statin treatment.
Fibrates and bile acid sequestrants are recommended for familial hypercholesterolaemia only (NICE CG171). See section 2.12 Lipid-regulating drugs for fibrates and section 1.9.2 Bile acid sequestrants.
Seek advice or refer in the following circumstances:
Triglyceride > 20mmol/L
Triglyceride 10 - 20mmol/L
Triglyceride 4.5 - 9.9mmol/L
Agree the use of atorvastatin at doses higher than 20mg/day with a renal specialist if eGFR is less than 30 mL/min/1.73m2
Consider seeking advice from a specialist if:
Agree the use of atorvastatin at doses higher than 20mg/day with a renal specialist if eGFR is less than 30 mL/min/1.73m2
Refer to specialists for consideration of a PCSK9 inhibitor (alirocumab or evolocumab) in the following circumstances:
Consider seeking advice from a specialist if following inclisiran treatment, the patient’s LDL-C remains persistently above 2.6 mmol/L.
Possible rhabdomyolysis
Stop statin, urgently seek specialist advice and inpatient assessment if:
Severe myopathy
Stop statin, refer for out-patient assessment if stable renal function and CK ≥ 10x and < 50x ULN
Myalgia / myopathy
Where statin treatment is stopped and CK ≥ 5x and < 10x ULN or intolerable symptoms or clinical concern:
Clinical referral guidance: South Devon; West Devon
Refer the person to a lipid clinic if:
Consider referral to a specialist for further treatment and/or consideration of PCSK9 inhibitor therapy (alirocumab or evolocumab) if: