CV risk and Lipids

This guidance applies to new patients and may also be taken into consideration for those already on statins at their annual review. If 40% reduction of non-HDL-C not achieved, offer high intensity statins. Discuss with people who are stable on a low- or medium-intensity statin the likely benefits and potential risk of side effects if changed to a high-intensity statin when they have a medication review and agree with the person whether a change is needed.

Ezetimibe, alirocumab, evolocumab or inclisiran can be added when patients’ LDL-C levels are not lowered enough with the maximally tolerated dose of statins. Bempedoic acid with ezetimibe is an option when statins are contraindicated or not tolerated, and when ezetimibe alone does not control LDL-C well enough. Do not offer a fibrate, nicotinic acid, bile acid binder or omega-3 fatty acids alone or in combination with statin, for the prevention of CVD (check NICE CG181 and TA805 for exceptions).

QRISK3 is the current version of the QRISK calculator. www.qrisk.org

• Do not use this risk assessment tool for people with established CVD or those who are at high risk of developing CVD because of FH or other inherited disorders of lipid metabolism.
• Do not use a risk assessment tool to assess CVD risk in people with type 1 diabetes, or eGFR less than 60 mL/min/1.73 m2 and/or albuminuria.
• Consider people aged ≥ 85 at increased risk of CVD because of age alone particularly people who smoke or have raised BP.

Type 1 Diabetes

• While NICE recommends offering statins to patients with Type 1 diabetes as detailed in the algorithm, it also states to consider statins in all adults with type 1 diabetes.

Chronic Kidney Disease

• Offer atorvastatin 20mg for the primary or secondary prevention of CVD to people with CKD (eGFR less than 60 mL/min/1.73m² and/or albuminuria)
• Increase the dose if a greater than 40% reduction in non-HDL-C is not achieved and eGFR is 30 mL/min/1.73m² or more.
• Agree the use of higher doses with a renal specialist if eGFR is less than 30 mL/ min/1.73m²

• Rosuvastatin may be used as an alternative to atorvastatin if compatible with other drug therapy. Some people may need a lower starting dose (see BNF).
• Low/medium intensity statins should only be used if intolerance or drug interactions.
• Ezetimibe when combined with any statin is likely to give greater reduction in non-HDL-C or LDL-C than doubling the dose of the statin.
• PCSK9i (NICE TA393, TA394) alone or in combination with statins or ezetimibe produce an additional LDL-C reduction of approximately 50% (range 25-70%).
• Bempedoic acid when combined with ezetimibe (TA694) produces an additional LDL-C reduction of approximately 28% (range 22-33%) but no clinical outcome evidence is currently available.
• Inclisiran (TA733) alone or in combination with statins or ezetimibe produces an additional LDL-C reduction of approximatey 50% (range 48-52%) but no clinical outcome evidence is currently available.

If baseline cholesterol is unknown in the setting of secondary prevention use the use Joint British Societies’ JBS3 consensus recommendation.

Non-HDL-C = TC minus HDL-C

LDL-C = non-HDL-C minus (Fasting triglycerides^a/2.2)
^a valid only when fasting triglycerides are less than 4.5 mmol/L

Scope of specialist service available locally may include; lipid clinic, PCSK9i clinic (offering initiation and subsequent follow up), FH genetic diagnosis and cascade testing, lipoprotein apheresis service. NICE eligibility criteria for PCSK9i and fasting LDL-C thresholds are summarised below.

¹ History of any of the following: ACS; coronary or other arterial revascularisation procedures; CHD, ischaemic stroke; PAD.
² Recurrent CV events or CV events in more than 1 vascular bed (that is, polyvascular disease).

Bempedoic acid/ezetimibe and inclisiran are available in primary care and do not require initiation by specialist services. PCSK9i may be available for prescribing in primary care: see local initiation pathways.

* LDL-C cannot be calculated using Friedewald’s formula if TG >4.5. Discuss with your lab. Consider using an alternative equation (eg Sampson, doi: 10.1001/jamacardio.2020.0013) or beta-quantification.

‡ labs don’t report calculated LDL-C beyond one decimal point

Statin intolerance is defined as the presence of clinically significant adverse effects from statin therapy that are considered to represent an unacceptable risk to the patient or that may result in adherence to therapy being compromised.

If statin treatment is contraindicated or not tolerated:

• See the NHSE AAC statin intolerance algorithm for advice regarding adverse effects.
• Ezetimibe 10mg monotherapy may be considered. Assess response after 3 months.
• Ezetimibe 10mg/bempedoic acid 180 mg combination may be considered when ezetimibe alone does not control non-HDL-C/LDL-C well enough (NICE TA694)