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Summary of National Guidance for Lipid Management for Primary and Secondary Prevention of CVD INITIAL CONSIDERATIONS: ● Measure non-fasting full lipid profile (total cholesterol, HDL-C, non-HDL-C, triglycerides) and HbA1c as part of an initial baseline assessment. ● Consider secondary causes of hyperlipidaemia and manage as needed. ● Ensure appropriate baseline and follow up tests as detailed on page 2. Measure BMI. ● Identify and exclude people with contraindications/drug interactions ● If non-fasting triglyceride above 4.5mmol/L see page 2. PRIMARY PREVENTION SEVERE HYPERLIPIDAEMIA SECONDARY PREVENTION Consider statin therapy for adults who do not have established CVD but fall into the categories If TC>7.5mmol/L and/or LDL-C Offer statin therapy to adults with CVD, this includes CHD, angina, Acute Coronary Syndrome (MI or unstable below. Use QRISK risk assessment tool where appropriate (see page 2, ‘Primary Prevention >4.9mmol/L and/or non-HDL-C angina), revascularisation, stroke or TIA, or symptomatic peripheral arterial disease. Do not delay statin Risk Assessment’) >5.9mmol/L, a personal and/or family treatment if a person has acute coronary syndrome. Take a lipid sample on admission (within 24 hours). history of confirmed CHD (<60 years) and with no secondary causes: suspect familial hypercholesterolaemia Identify and address all modifiable risk factors - smoking, diet, obesity, alcohol intake, (possible heterozygous FH) physical activity, blood pressure and HbA1c. Age ≤84 Type 2 Type 1 diabetes, if they have one CKD eGFR Age ≥85 Do not use QRISK risk assessment tool & QRISK diabetes or more of the following: < 60 years SECONDARY PREVENTION 2 ≥10% & QRISK • Over 40 years mL/min/1.73m if appropriate Do not delay statin treatment in secondary prevention while managing modifiable risk factors. over next ≥10% • Had diabetes for >10 years and/or consider Prescribe a high intensity statin: 10 years over next albuminuria comorbidities, Atorvastatin 80mg daily 10 years • Have established nephropathy frailty & life DIAGNOSIS AND REFERRAL Use a lower dose of atorvastatin if there is a potential drug interaction, high risk of or experiencing • Have other CVD risk factors expectancy Take fasting blood for repeat lipid adverse effects, or patient preference. profile to measure LDL-C. Offer atorvastatin 20mg if CKD (people with GFR< 60 mL/min/1.73m ). 2 Use the Simon Broome or Dutch Identify and address all modifiable risk factors - smoking, diet, obesity, alcohol intake, Lipid Clinic Network (DLCN) criteria physical activity, blood pressure and HbA1c. • Measure full lipid profile again after 3 months (non-fasting). to make a clinical diagnosis of FH. Refer to Lipid Clinic for further • High intensity statin treatment should achieve reduction of non-HDL-C > 40% from baseline. If not achieved after 3 months Consider additional risk factors, if present, together with QRISK score (treated for HIV, assessment if clinical diagnosis of FH - discuss treatment adherence, timing of dose, diet and lifestyle measures severe mental illness, taking medicines that cause dyslipidaemia, systemic inflammatory disorder or if TC>9.0mmol/L and/or - If started on less than atorvastatin 80mg and the person is judged to be at higher risk (based on (e.g. SLE), impaired fasting glycaemia, recent change in risk factors) LDL-C >6.5mmol/L and/or non-HDL-C >7.5mmol/L or comorbidities, risk score or clinical judgement - see page 2 ‘Additional Risk Factors’), consider increasing to 80mg atorvastatin. For how to increase in people with CKD see ‘Special Patient Populations’ (page 2). Fasting triglycerides > 10mmol/L • If non-HDL-C baseline value is not available*, consider target non-HDL-C < 2.5mmol/L (approximately PRIMARY PREVENTION (regardless of family history) (page 2) equivalent to LDL-C < 1.8mmol/L) as recommended by Joint British Societies (JBS3). If lifestyle modification is ineffective or inappropriate offer statin treatment. *this scenario is not currently covered by NICE CG181. NICE will consider this as part of the guideline Atorvastatin 20mg daily update with publication currently expected September 2023 • If patients on a high-intensity statin have side effects, offer a lower dose or an alternative statin TREATMENT TARGETS IN FH (see page 2 ‘Extent of lipid lowering with available therapies’) • Measure full lipid profile again after 3 months (non-fasting). If clinical diagnosis of FH and/or • High intensity statin treatment should achieve reduction of non-HDL-C > 40% from baseline. If If maximum tolerated dose of statin does not control non-HDL-C/LDL-C well enough after 3 months confirm not achieved after 3 months; other risk factors present follow the recommended treatment management statin adherence, then consider the following options based on shared decision making* with the patient - discuss treatment adherence, timing of dose, diet and lifestyle pathway for primary or secondary - If at higher risk (based on comorbidities, risk score or clinical judgement – see page 2 prevention as for non-FH, BUT ‘Additional Risk Factors’) consider increasing the dose every 2-3 months up to a maximum If recommended statin treatment is Ezetimibe 10mg Injectable therapies** dose of atorvastatin 80mg daily. Aim to achieve at least a 50% contraindicated or not tolerated - follow daily (NICE TA385). If non-HDL-C > 2.5mmol/L; reduction of LDL-C (or non-fasting AAC Statin Intolerance Algorithm for advice Reassess after three Arrange fasting blood test to - For how to increase in people with CKD see ‘Special Patient Populations’ (page 2). non-HDL-C) from baseline. regarding adverse effects (click here). months. If non-HDL-C measure LDL-C to assess remains > 2.5mmol/L; Consider specialist referral for eligibility: • If patients on a high-intensity statin have side effects, offer a lower dose or an alternative statin further treatment and/or If statin intolerance is confirmed, consider: consider injectable - Inclisiran - if fasting LDL-C (see page 2 ‘Extent of lipid lowering with available therapies’) - Ezetimibe 10mg monotherapy. Assess therapies arrange a ≥ 2.6mmol/L despite consideration of PCSK9i therapy IF fasting blood test and • If maximum tolerated dose of statin does not achieve non-HDL-C reduction > 40% of baseline - they are assessed to be at very high response after 3 months (TA385) assess eligibility maximum tolerated lipid value after 3 months consider adding Ezetimibe 10mg daily (NICE TA385) risk of a coronary event** - Ezetimibe 10mg/bempedoic acid 180 mg lowering therapy (TA733) - OR therapy is not tolerated combination when ezetimibe alone does not OR • If statin treatment is contraindicated or not tolerated; - OR LDL-C remains >5mmol/L control non-HDL-C sufficiently. (NICE TA694) - See AAC Statin Intolerance Algorithm for advice regarding adverse effects (click here) - PCSK9i - see overleaf for - Ezetimibe 10mg monotherapy may be considered. Assess response after 3 months. (primary prevention) * Seeoverleaf for informationtoLDL-C thresholds. (TA393/4) - Ezetimibe 10mg/bempedoic acid 180 mg combination may be considered when ezetimibe - OR LDL-C remains >3.5mmol/L If non HDL-C remains > 2.5mmol/L despite support shareddecisionmaking (secondary prevention) ** InclisiranandPCSK9i shouldIf eligibility criteria not met, alone does not control non-HDL-C/LDL-C well enough (NICE TA694). other lipid lowering therapies consider not beprescribedconcurrentlyconsider ezetimibe 10mg despite maximal tolerated statin and Injectable therapies - arrange a fasting blood test daily (if not previously ezetimibe therapy. and assess eligibility criteria (TA393/394, TA733) considered) If non-HDL-C reduction remains < 40% of baseline despite maximal tolerated lipid lowering **defined as any of the following: therapy (including people with intolerances and contraindications) consider referral to specialist • Established coronary heart disease Additional CV risk reduction considerations - check fasting triglycerides levels and consider icosapent lipid management clinic according to local arrangements • Two or more other CVD risk factors ethyl. See triglycerides section overleaf. MANAGEMENT EXTENT OF LIPID LOWERING WITH AVAILABLE THERAPIES TITRATION THRESHOLD / TARGETS This guidance applies to new patients and may also be taken into consideration Approximate reduction in LDL-C NICE titration threshold JBS3 for those already on statins at their annual review. If 40% reduction of non-HDL-C Primary not achieved, offer high intensity statins. Discuss with people who are stable on a Statin dose mg/day 5 10 20 40 80 prevention Intensify lipid lowering therapy if non-HDL-C low- or medium-intensity statin the likely benefits and potential risk of side effects Fluvastatin 21% 27% 33% non-HDL-C reduction from baseline <2.5mmol/L (LDL-C Secondary if changed to a high-intensity statin when they have a medication review and Pravastatin 20% 24% 29% Prevention is less than 40% <1.8mmol/L) agree with the person whether a change is needed. Simvastatin 27% 32% 37% 42% FH Optimise lipid lowering therapy to Ezetimibe, alirocumab, evolocumab or inclisiran can be added when patients’ Atorvastatin 37% 43% 49% 55% achieve at least 50% reduction in LDL-C levels are not lowered enough with the maximally tolerated dose LDL-C (or non-HDL-C.) of statins. Bempedoic acid with ezetimibe is an option when statins are Rosuvastatin 38% 43% 48% 53% contraindicated or not tolerated, and when ezetimibe alone does not control Atorvastatin + Ezetimibe 10mg 52% 54% 57% 61% If baseline cholesterol is unknown in the setting of secondary prevention use the use Joint British Societies’ JBS3 consensus recommendation. LDL-C well enough. Do not offer a fibrate, nicotinic acid, bile acid binder or Low intensity statins will produce an LDL-C reduction of 20-30% Non-HDL-C = TC minus HDL-C omega-3 fatty acids alone or in combination with statin, for the prevention of CVD LDL-C = non-HDL-C minus (Fasting triglycerides /2.2) (check NICE CG181 and TA805 for exceptions). Medium intensity statins will produce an LDL-C reduction of 31-40% a valid only when fasting triglycerides are less than 4.5 mmol/L High intensity statins will produce an LDL-C reduction above 40% PRIMARY PREVENTION RISK ASSESSMENT Simvastatin 80mg is not recommended due to risk of muscle toxicity SPECIALIST SERVICES QRISK3 is the current version of the QRISK calculator. www.qrisk.org/three Scope of specialist service available locally may include; lipid clinic, PCSK9i • Rosuvastatin may be used as an alternative to atorvastatin if compatible with - Do not use this risk assessment tool for people with established CVD or those clinic (offering initiation and subsequent follow up), FH genetic diagnosis and who are at high risk of developing CVD because of FH or other inherited other drug therapy. Some people may need a lower starting dose (see BNF). cascade testing, lipoprotein apheresis service. NICE eligibility criteria for PCSK9i disorders of lipid metabolism. • Low/medium intensity statins should only be used if intolerance or drug interactions. and fasting LDL-C thresholds are summarised below. - Do not use a risk assessment tool to assess CVD risk in people with type 1 • Ezetimibe when combined with any statin is likely to give greater reduction in NICE TA393 Alirocumab Without CVD With CVD diabetes, or eGFR less than 60 mL/min/1.73 m and/or albuminuria. non-HDL-C or LDL-C than doubling the dose of the statin. 1 2 • PCSK9i (NICE TA393, TA394) alone or in combination with statins or ezetimibe NICE TA394 Evolocumab High risk Very high risk - Consider people aged ≥ 85 at increased risk of CVD because of age alone Primary non-FH or mixed Not recommended LDL C > 4.0 LDL C > 3.5 particularly people who smoke or have raised BP. produce an additional LDL-C reduction of approximately 50% (range 25-70%). dyslipidaemia mmoL/L mmoL/L • Bempedoic acid when combined with ezetimibe (TA694) produces an additional Additional Risk Factors Primary heterozygous-FH LDL C > 5.0 LDL C > 3.5 LDL-C reduction of approximately 28% (range 22-33%) but no clinical outcome mmoL/L mmoL/L Note, standard CVD risk scores including QRISK may underestimate risk in evidence is currently available. 1 people who have additional risk because of underlying medical conditions or • Inclisiran (TA733) alone or in combination with statins or ezetimibe produces an History of any of t2e following: ACS; coronary or other arterial revascularisation procedures; CHD, treatments. These groups include the following groups of people; ischaemic stroke; PAD. Recurrent CV events or CV events in more than 1 vascular bed (that is, 2 additional LDL-C reduction of approximately 50% (range 48-52%) but no clinical polyvascular disease). • severe obesity (BMI>40kg/m ) increases CVD risk outcome evidence is currently available. Bempedoic acid/ezetimibe and inclisiran are available in primary care and do not • treated for HIV require initiation by specialist services.’ PCSK9i may be available for prescribing MONITORING • serious mental health problems in primary care: see local initiation pathways. • taking medicines that can cause dyslipidaemia such as antipsychotic Baseline Measurements medication, corticosteroids or immunosuppressant drugs In addition to full lipid profile, measure renal, thyroid and liver profiles (including TRIGLYCERIDES albumin) and HbA1c to exclude secondary causes and co-morbidities. • autoimmune disorders such as SLE, and other systemic inflammatory disorders Triglyceride Action • non-diabetic hyperglycaemia Measure baseline liver transaminase (ALT or AST) before starting a statin. concentration Measure CK if unexplained muscle pain before starting a statin. Greater than Refer to lipid clinic for urgent specialist review if not a result of • significant hypertriglyceridaemia (fasting triglycerides 4.5-9.9mmol/L) CK should not be measured routinely especially if a patient is asymptomatic. 20mmol/L excess alcohol or poor glycaemic control. At risk of acute pancreatitis. • recent risk factor changes e.g. quit smoking, BP or lipid treatment Primary Prevention Secondary prevention 10 - 20mmol/L Repeat the TG measurement with a fasting test (after an interval of 5 Consider socio-economic status as an additional factor contributing to CVD risk. days, but within 2 weeks) and review for potential secondary causes If QRISK < 10% over the next 10 years - Give lifestyle advice and ensure Lipid Profile ALT or AST Lipid Profile ALT or AST of hyperlipidaemia. Seek specialist advice if the TG concentration Baseline     regular review of CVD risk in line with guidance. remains > 10mmol/litre. At risk of acute pancreatitis 3 months     4.5 - 9.9mmol/L If non-fasting triglycerides are greater than 4.5mmol/L, repeat with SPECIAL PATIENT POPULATIONS a fasting TG measurement Be aware that the CVD risk may be 6-9months If <40% non-HDL-C reduction, up titration required. Repeat full lipid underestimated by risk assessment tools, optimise the management Type 1 Diabetes profile and ALT or AST within 3 months of each up-titration of statin While NICE recommends offering statins to patients with Type 1 diabetes as detailed dose or addition of ezetimibe as required of other CVD risk factors present and seek specialist advice if non- in the algorithm, it also states to consider statins in all adults with type 1 diabetes. 12 months HDL-C concentration is > 7.5 mmol/litre.     Chronic Kidney Disease Yearly * * Icosapent ethyl (TA805) •Check fasting triglycerides levels. Offer atorvastatin 20mg for the primary or secondary prevention of CVD to Provide annual medication reviews for people taking statins to discuss effectiveness of therapy, people with CKD (eGFR less than 60 mL/min/1.73m 2 and/or albuminuria) medicines adherence, lifestyle modification and address CVD risk factors. •Manage secondary causes of hypertriglyceridaemia. *Consider an annual non-fasting full lipid profile to inform the discussion around effective•Consider icosapent ethyl (TA805) if patient has established cardiovascular disease Increase the dose if a greater than 40% reduction in non-HDL-C is not achieved lowering therapy and any medicines non-adherence. and eGFR is 30 mL/min/1.73m or more. (secondary prevention) and ‡ Monitoring - on statins and fasting TG ≥ 1.7mmol/L and LDL-C* between 1.04 and ≤2.6mmol/L Agree the u2e of higher doses with a renal specialist if eGFR is less than 30 mL/ Repeat full lipid profile is non-fasting. • See table above and refer as appropriate. min/1.73m Measure liver transaminase within 3 months of starting treatment and then within * LDL-C cannot be calculated using Friedewald’s formula if TG >4.5. Discuss with your lab. Consider ABBREVIATIONS 3 months of every additional up titration and then again at 12 months, but not using an alternative equation (eg Sampson, doi: 10.1001/jamacardio.2020.0013) or beta-quantification. again unless clinically indicated. ‡ labs don’t report calculated LDL-C beyond one decimal point ALT: alanine aminotransferase LDL-C: low density lipoprotein cholesterol AST: aspartate aminotransferase non-HDL-C: non-high density lipoprotein cholesterol If ALT or AST are greater than 3 times the upper limit of normal then do not initiate a STATIN INTOLERANCE CHD: coronary heart disease PCSK9i: proprotein convertase subtilisin kexin 9 statin or discontinue statin therapy already prescribed and repeat the LFTs in a month. CKD: chronic kidney disease monoclonal antibody inhibitor If ALT or AST are elevated but are less than 3 times the upper limit of normal then: Statin intolerance is defined as the presence of clinically significant adverse effects from statin therapy that are considered to represent an unacceptable risk CVD: cardiovascular disease SLE: systemic lupus erythematosus • Continue the statin and repeat in a month. to the patient or that may result in adherence to therapy being compromised. FH: familial hypercholesterolaemia SPC: summary of product characteristics • If they remain elevated but are less than 3 times the upper limit of normal then TC: total cholesterol continue statin and repeat again in 6 months. For people who are intolerant of the recommended statin treatment see the NHSE AAC statin intolerance algorithm, available on the NHSE AAC page (Click here) References: Authors: Dr Rani Khatib & Dr Dermot Neely on behalf of the AAC Clinical Subgroup. JBS3. 2014. www.jbs3risk.com/pages/6.htm NICE 2016. TA385 www.nice.org.uk/guidance/ta385 NICE 2008. CG71 www.nice.org.uk/guidance/cg71 Nov 2022. Review date: Nov 2023. Kirsten et al. 2005. Hospital Pharmacy 40(8):687-692 NICE 2016. TA393 www.nice.org.uk/guidance/TA393 NICE 2021. TA694 www.nice.org.uk/guidance/TA694 Navarese et al. 2015. Annals of internal medicine 163(1):NICE 2016. TA394 www.nice.org.uk/guidance/TA394 NICE 2021. TA733 www.nice.org.uk/guidance/TA733 NICE confirmed that its guidance is accurately Soon Jun Hong et al. 2018. Clinical therapeutics 40(2): 2NICE 2014. CG181 www.nice.org.uk/guidance/CG181 NICE 2022. TA805 www.nice.org.uk/guidance/ta805 represented, Nov 2022.