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Page last updated:
4 November 2024
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
See NICE patient decision aid on should I take a statin? ‘Should I take a statin’ to support discussions for people without CVD
Clinical referral guidance
Devon Lipid Service: East Devon; North Devon
Familial hypercholesterolaemia: East Devon; North Devon
Baseline measurements and monitoring:
HbA1c no longer required at baseline. Check patient’s diabetes status.
Primary prevention: risk assessment:
Secondary prevention:
Familial hypercholesterolaemia:
Simon Broome and Dutch Lipid Clinic Network criteria removed, refer to clinical referral guidance for assessment and referral criteria.
Refer to clinical referral guidance (below) for assessment and referral criteria for familial hypercholesterolaemia if:
Do not use the QRISK assessment tool.
Clinical referral guidance: East Devon; North Devon
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 CVD 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.
If QRISK <10% over the next 10 years - give lifestyle advice and ensure regular review of CVD risk in line with guidance.
Use QRISK3 version of the calculator (or QRISK2 if not available).
QRISK2 may underestimate 10-year CVD risk in the following patient populations. Use QRISK3 (online version, if necessary) to estimate CVD risk:
Consider using a lifetime risk tool such as QRISK3-lifetime to inform discussions on CVD risk and to motivate lifestyle changes, particularly for people with a 10-year QRISK3 score less than 10%, and people under 40 who have CVD risk factors.
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.
Discuss benefits of lifestyle changes and optimise management of all other modifiable CVD risk factors if possible. Offer people the opportunity to have their risk of CVD assessed again after they have tried to change their lifestyle.
Before starting statins, treat comorbidities and secondary causes of dyslipidaemia.
Advice for patient on statins:
Treatment target: Non-HDL-C reduction >40% from baseline.
If lifestyle modification is ineffective or inappropriate:
If statin contraindicated: see below for options
Measure non-fasting lipid profile again within 2 to 3 months.
High intensity statin treatment should achieve >40% reduction in non-HDL-C. If not achieved within 2 to 3 months:
If ≤40% reduction in non-HDL-C on maximum tolerated statin dose:
See ‘Statin Intolerance’ below for advice on adverse effects. Therapy with a low dose statin is preferred to no statin.
Side effects on a high-intensity statin: offer a lower dose or an alternative statin:
If ≤40% reduction in non-HDL-C on maximum tolerated statin dose:
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 2.12 Lipid-regulating drugs)
Measure non-fasting lipid profile again within 2 to 3 months.
If ≤40% reduction in non-HDL-C on ezetimibe, consider bempedoic acid 180mg (with ezetimibe 10mg) once daily.
Assess response within 2 to 3 months, if ≤40% reduction in non-HDL-C despite maximum tolerated lipid-lowering therapy, consider seeking specialist advice.
Offer statin therapy to adults with CVD:
Do not delay starting statin treatment for secondary prevention while optimising management of modifiable CVD risk factors. Treat comorbidities and secondary causes of dyslipidaemia at the same time as starting statin treatment.
Do not delay statin treatment if a person has acute coronary syndrome. Measure full lipid profile on admission (within 24 hours).
Advice for patient on statins:
Treatment target: LDL-C 2.0 mmol/L or less, or non-HDL-C 2.6 mmol/L or less.
Offer Atorvastatin 80mg once daily (see 2.12 Lipid-regulating drugs)
If statin contraindicated, see below for options.
Measure full lipid profile again within 2 to 3 months. If target lipid level not achieved:
Measure lipid profile within 2 to 3 months:
See ‘Statin Intolerance’ below for advice on adverse effects. Therapy with a low dose statin is preferred to no statin.
Side effects on a high-intensity statin, offer a lower dose or an alternative statin:
Measure lipid profile within 2 to 3 months of a change in dose or statin:
If maximum tolerated dose of statin does not achieve target lipid level
*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 full lipid profile (including LDL-C) 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 2.12 Lipid-regulating drugs)
Measure non-fasting lipid profile again within 2 to 3 months.
If target lipid not achieved, consider bempedoic acid 180mg (with ezetimibe 10mg) once daily.
Assess response within 2 to 3 months:
The place in therapy for injectable therapies is outlined above when statins are not effective, contra-indicated or not tolerated.
See 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.
Refer to clinical referral guidance for assessment and referral criteria: East Devon; North Devon
Primary and secondary prevention
Follow the treatment management pathway for primary or secondary prevention above.
Treatment target:
Consider referral to a specialist for further treatment and/or consideration of a PCSK9 inhibitor (alirocumab or evolocumab) if:
These recommendations apply to primary and secondary prevention of CVD, including people with diabetes and CKD. They do not apply to people with familial hypercholesterolaemia.
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 a bile acid sequestrant (anion exchange resin), nicotinic acid or omega-3 fatty acids to prevent CVD. This does not apply to icosapent ethyl with statin if used in line with NICE TA805.
Do not routinely offer fibrates to prevent CVD.
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 2.12 Lipid-regulating drugs for fibrates and 1.9.2 Bile acid sequestrants.