APPENDIX 2F Management of Cholesterol

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1 Patients with established CVD: Coronary heart disease Cerebrovascular disease Peripheral vascular disease APPEDIX 2F Management of Cholesterol Patients at high risk of cardiovascular events: Chronic kidney disease or micro/macroalbuminuria Familial hypercholesterolemia Over the age of 40 and have diabetes Patients requiring risk assessment: All adults aged 40 years or above Individuals at any age with a first degree relative who has premature atherosclerotic cardio vascular disease Under the age of 40 and have diabetes with at least 20 years duration of disease, or target organ damage Familial dyslipidaemia Lifestyle advice Check base-line LFT s Offer: atorvastatin 80mg daily Lifestyle advice Check base-line LFT s Offer: atorvastatin 20mg daily Assess CVD risk using ASSIG Score: Age Sex Postcode FH CHD/Stroke (/) Diabetes (/) Rheumatoid arthritis (/) Smoker (/) Systolic BP Total Cholesterol HDL Cholesterol Check non-hdl cholesterol and LFTs after 3 months Is CVD 10 year risk >20%? Secondary Prevention: Target achieved (greater than 40% reduction in non HDL cholesterol) Primary Prevention: Target achieved (greater than 40% reduction in non HDL cholesterol) Lifestyle Advice Re-calculate CVD risk score every 5 years Check medication adherence Re-enforce diet and lifestyle measures. See accompanying notes for further treatment options. otes to Ac Continue with current medication regimen and diet and lifestyle measures. Annual review Check medication adherence. Re-enforce diet and lifestyle measures. Consider increasing dose of atorvastatin. See accompanying notes for further treatment options.

2 otes 1. IDETIFIG AD ASSESSIG CARDIOVASCULAR DISEASE (CVD) RISK People with an estimated 10 year risk of CVD > 10% should undergo full CVD risk assessment. Please consider that these tools only approximate risk and interpretation should reflect informed clinical judgement Clinical Assessment This will focus on secondary causes, other vascular risk factors and evidence of end organ damage. History personal and/or family history of CVD, lifestyle including alcohol, smoking and diet Drug history thiazides, beta blockers, retinoids, anti-retrovirals and synthetic oestrogen/progesterone Examination blood pressure, BMI, arrhythmias. Peripheral vascular disease, heart failure, signs of hyperlipidaemia and fundoscopy Urine blood, protein and glucose ECG if clinically indicated 1.2. Biochemical tests (all can be taken non fasting) Full lipid profile - total cholesterol, LDL, HDL and triglycerides (see section 5 for further details) Createnine/eGFR LFTs focussing on ALT and ygt Blood Glucose Thyroid function 1.3. Estimation of CVD risk Primary prevention ASSIG (http;//cvrisk.mvm.ed.ac.uk/calculator/calc.asp, select CVD ASSIG) is the preferred calculator in Scotland. QRISK2 ( is an alternative. CVD risk calculators should be used to assess 10 year cardiovascular risk in those years old (inclusive). Please be aware that CVD risk calculators underestimate risk up to 2-fold in those with obesity, HIV, systematic inflammatory conditions and in certain ethnic populations, particularly south asian men. Do not use the CVD risk assessment calculators in those with CKD or familial hypercholesterolaemia (FH), ASSIG cannot be used to calculate risk in those with diabetes mellitus but QRISK2 can Secondary prevention do not use the CVD risk assessment calculators in those with established CVD. 2. MAAGEMET 2.1. Lifestyle modification may help: (i) improve lipid profile; (ii) reduce BP; and (iii) reduce overall CVD risk. Weight aim for BMI but even modest weight loss reduces morbidity. Diet reduced salt, saturated fat. Increased consumption of fruit, vegetables and oily fish Exercise - ideally 30 plus minutes 3 times per week Alcohol weekly limits (male <14 units; female <14 units) Smoking cessation vital to reduce overall CVD risk, RT may help Do not routinely recommend plant stanols/sterols to patients at risk of CVD Pharmacological management Atorvastatin is now the first line agent (based on evidence, cost and efficacy) Primary prevention: Atorvastatin 20 mg daily Secondary prevention: Atorvastatin mg daily Patients with CKD: Atorvastatin 20 mg daily. If the person has not achieved a greater than 40% reduction in non-high density lipoprotein (HDL) cholesterol after 3 months of treatment: o For people with an egfr of 30 ml/min/1.73 m 2 or more, consider increasing the dose of atorvastatin up to a maximum of 80 mg daily (if tolerated)

3 o For people who have an egfr of 30 ml/min/1.73 m 2 or less, seek specialist advice from a nephrologist before increasing the dose of atorvastatin Patients with Type 1 or Type 2 diabetes: consider atorvastatin 20mg daily. Most people with type 2 diabetes aged over 40 should receive treatment with a statin and it should be considered in Type 1 diabetes. A positive decision OT to prescribe statin may be considered at ages when there are no other CVD risk factors. Patients with evidence of nephropathy are at high CVD risk and should be treated intensively Aims of treatment and targets Primary prevention provide annual medication reviews for people taking statins. Use these reviews to discuss adherence with medications, lifestyle modification and address CVD risk factors. Consider a non-fasting total cholesterol and LDL to inform the discussion. There are no specific targets identified for primary prevention Secondary prevention and those taking high intensity statin treatment i.e. > 40mg atorvastatin or > 20mg rosuvastatin. Measure total cholesterol, non HDL cholesterol in all people who have been started on a statin treatment at 3 months of treatment and aim for a LDL cholesterol of <2 mmol/l. If this target is not achieved, discuss adherence, optimise lifestyle measures and increase the dose. Atorvastatin 80 mg daily is the target dose in those that have not encountered adverse effects. Treatment thresholds in primary prevention cardiovascular risk >20% Offer statin treatment cardiovascular risk 10-20% Discuss lifestyle modification and consider statin treatment. cardiovascular risk <10% Reassess at intervals based on clinical judgement. Annual assessment in those requiring treatment is recommended. Treatment of older patients (> 85 years) in primary prevention is a judgement based on frailty and benefit from treatment (reduces non-fatal myocardial infarction). 3. MOITORIG ADVERSE EFFECTS AD ITOLERACE Consider using a lower dose of atorvastatin if any of the following apply: potential drug interactions, high risk of adverse effects (detailed in section 3.2) or patient preference Statin-drug interactions: atorvastatin and simvastatin are prodrugs metabolised predominantly by the cytochrome P450 system; therefore, drugs that induce/inhibit these enzymes will affect plasma statin concentrations (pravastatin and rosuvastatin are not metabolised by P450). Advise patients that some drugs (warfarin, macrolides e.g. clarithromycin; calcium channel blockers e.g. amlodipine), foods (grapefruit juice) and supplements (St. John s Wort) may interfere with statin metabolism. Further advice is available from the MHRA regarding simvastatin and atorvastatin drug interactions. Remind patients to always consult the patient information leaflet, a pharmacist or prescriber before starting any new medication (for further advice consult the BF).

4 3.2 Monitoring adverse effects Liver function tests measure baseline LFTs before starting a statin. Measure again within 3 months of starting treatment and at 12 months, but not again unless clinically indicated Managing abnormal LFT results in people taking statins If LFTs are less than three times the upper limit of normal: o Continue the statin but recheck LFTs within 4 6 weeks to exclude further increases in transaminase levels. o o extra monitoring is required if values are stable. If transaminase levels are three or more times the upper limit of normal: o Consider the following options: Stop the statin and recheck LFTs within 4 6 weeks to ensure that values settle (consider re-introducing the statin cautiously at a later date), or Reduce the statin dose (if the person is taking a high dose) and recheck LFTs within 4 6 weeks, or Change to a statin in a lower intensity group (for example change to a medium-intensity statin if the person is taking a high-intensity statin) and recheck LFTs within 4 6 weeks. If transaminase levels continue to be three times the upper limit of normal or more, stop the statin Myopathy if a patient is complaining of generalised muscle pain prior to commencing statin treatment, check a CK. If CK > 5 x upper limit of normal, investigate for myopathy and postpone statin treatment Statin intolerance statins are more effective that any other lipid lowering option. If someone reports adverse effects when taking statins discuss: (i) stopping the statin and trying again when the symptoms have resolved check if the symptoms are related to the statin; (ii) reducing the dose within the same intensity group; or (iii) changing the statin to a lower intensity group, as detailed in Ezetimibe there may be a role for ezetimibe in secondary prevention in patients who are statin intolerant (intolerance to > 3 agents) or those who fail to achieve target LDL on maximum tolerated dose of statin. SIG 149 states ezetimibe and bile sequestriant therapy should only be considered for primary prevention in patients at elevated CVD risk in whom statin therapy is contraindicated, and in patients with hypercholesterolaemia. Ezetimibe and bile acid sequestrant therapy should be considered for secondary prevention in combination with maximum tolerated statin therapy if LDL cholesterol is considered to be inadequately controlled. Consider referral for specialist advice Other drugs PCSK9 inhibitors (alirocumab, evolocumab) may only be initiated by the Lothian Lipid Clinic Pregnancy Statin use is strictly contraindicated in pregnancy. 4. SPECIALIST REFERRAL All referrals to Lothian and Tayside are dictated by Dr Francis, typed and sent in letter form to the appropriate consultant with a copy to the GP. Definite or probable heterozygous familial (FH) Intolerance to > 3 different statins Complex risk assessment Please exclude and manage possible common secondary causes of dyslipidaemia (such as excess alcohol, uncontrolled diabetes, hypothyroidism, liver disease and nephritic syndrome) before referring for specialist review Familial Hypercholesterolaemia (FH) patients with the condition are at especially high risk of premature CVD. It has an autosomal dominant inheritance and is defined using the Simon Broome criteria: Definite FH: Total cholesterol > 7.5 mmol/ or LDL > 4.9 mmom/l PLUS Tendon xanthomas in the patient or a 1 st /2 nd degree relative. Probable FH: Total cholesterol > 7.5 mmol/l or LDL > 4.9 mmom/l PLUS one of either

5 Family history of MI: < 60 years in a 1 st degree relative or < 50 in a second degree relative. OR Cholesterol > 7.5 mmol/l in a 1 st /2 nd degree relative.

Primary Prevention Patients aged 85yrs and over

Primary Prevention Patients aged 85yrs and over Rotherham Guideline for the management of Non-Familial Hypercholesterolaemia Type 1 Diabetes Offer lifestyle advice Over 40yrs of age? Diabetic for more than 10 years? Established nephropathy? Other CVD