Oxfordshire CCG Lipid Management Guidance Updated April Inside this issue: guidelines.

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1 Prescribing Points A NEWSLETTER FOR ALL HEALTH CARE PROFESSIONALS IN OXFORDSHIRE, WRITTEN BY THE MEDICINES MANAGEMENT TEAM, OXFORDSHIRE CCG, JUBILEE HOUSE, OXFORD BUSINESS PARK SOUTH, OXFORD, OX4 2LH. Date of issue: April 2013 Written by Kathryn Buchanan & Laura Tully. VOLUME No: Updated lipid guidelines Inside this issue: Updated lipid guidelines 1 Oxfordshire CCG Lipid Management Guidance Updated April 2013 Simvastatin and atorvastatin have the most compelling evidence for clinical outcomes. Until recently simvastatin has the best balance of safety, efficacy and costs compared to the other statins, but now that atorvastatin is available generically, it is also a preferred statin choice. The local consensus guidelines for the secondary prevention of CHD recommend starting atorvastatin 40mg. For primary prevention of CHD, APCO recommends simvastatin 40mg or atorvastatin 10mg regardless of initial cholesterol levels. Key points: QRISK2 is the CCG preferred risk assessment tool; those with a risk score of 20% or more should be offered treatment in primary prevention Avoid CVD risk calculation in high risk patients or in cases where familial conditions are expected; instead use clinical judgement as below (risk tools underestimate the risk) It is important to involve the patient in the decision to commence treatment. For primary prevention start with simvastatin 40mg or atorvastatin 10mg. There are no lipid targets Patients with diabetes over the age of 40 and those with chronic renal failure are considered high risk and as such should be treated as secondary prevention For secondary prevention start with atorvastatin 40mg; there is no evidence to support starting lower and titrating up. Consider further intensification to meet lipid targets. There is no need to switch patients who are treated to target on simvastatin If Simvastatin or Atorvastatin is not tolerated, then try lower doses or switch to the other recommended statin. 3 rd line options include pravastatin for primary prevention, rosuvastatin for secondary prevention. Intolerance to initial statin therapy should be 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 compliance with therapy being compromised. Adverse effects should be interpreted and balanced against the individual CV risk of the patient. Adverse effects include evidence of new-onset muscle pain (often associated with levels of muscle enzymes in the blood indicative of muscle damage), significant gastrointestinal disturbance or alterations of liver function tests. See Monitoring section for further detail Alternatives to Simvastatin, Atorvastatin or Pravastatin should not normally be considered for primary prevention. Statins are unlikely to be the first line treatment in cases with plasma triglyceride concentrations above 10 mmol/l, see Hypertriglyceridaemia guidelines. So What For new primary prevention patients simvastatin 40mg or atorvastatin 10mg are recommended as first line options regardless of initial cholesterol levels. Existing patients do not need to be switched. For new secondary prevention patients atorvastatin 40mg is recommend as the first line option. Existing patients do not need to be switched unless they are not currently being treated to target.

2 Who to consider for Statin Treatment? 1. First priority for treatment - patients with clinical atherosclerotic disease (secondary prevention). These patients are at highest risk of a vascular event: history of myocardial infarction (MI), angina, or coronary revascularisation, peripheral vascular disease (PVD), transient ischaemic attack (TIA) or ischaemic stroke, and patients with type I and II diabetes over the age of 40. In addition patients with chronic renal failure are considered to be high risk. These patients do not need a formal coronary risk assessment because they are at a high enough risk to warrant treatment. Those with familial hypercholesterolaemia (FH) or other clear familial conditions associated with CVD, should not have a risk assessment and should be considered for treatment as they are at high risk. Consider FH if cholesterol >7.5 mmol/l and LDL >4.9 and there is family history of either early MI or raised cholesterol. The presence of tendon xanthoma in the patient or a relative is pathognomonic. The majority of people with cholesterol >9 mmol/l, and normal triglycerides, will have FH. Since 50% of first-degree relatives will also be affected (autosomal dominant inheritance) family screening is advised. Consider Familial Combined hyperlipidaemia (FCH) in cases with combined hyperlipidaemia (TG >2 mmol/l and cholesterol >6 mmol/l if there is a clear family history of early MI. Decision on statin treatment of such cases should not be based on CVD risk scores either. Use clinical judgement or consult the Lipid Clinic. Lifestyle changes should be initiated in parallel with drug treatment; smoking cessation is the most important. 2. The second priority - patients with a high risk of a cardiovascular disease (CVD) event but who do not have clinical features of vascular disease (primary prevention). High risk is defined as an absolute CVD risk of 20% or more over 10 years (approx. 15% coronary heart disease [CHD] risk). Absolute CVD risk is estimated by the QRISK2 10 year risk equation. CVD Risk = 10 year risk of fatal and non fatal stroke, including TIA + 10 year risk of CHD A formal assessment must be done treatment based on a lipid level alone is not appropriate. Lipid levels alone are a poor predictor of risk. Individuals likely to be at high risk are those with a family history of premature CVD (i.e. a father or brother who had a vascular event before the age of 55, or a mother or sister before the age of 65), clinical signs of hyperlipidaemia, those originating from the Indian subcontinent, smokers, and hypertensives. Consider presence of familial hypercholesterolaemia and familial combined hypercholesterolaemia; these conditions are the first priority. Other high risk groups include patients on long-term antipsychotics, those with rheumatoid arthritis, or with systemic lupus. In primary prevention, smoking cessation alone may reduce absolute CHD risk sufficiently to eliminate the need for statin treatment. 3. Treating patients with a less than 20% 10-year CVD risk is NOT recommended. Patients at lower risk require lifestyle advice, including smoking cessation support. Follow-up may be appropriate. This applies even if hypertension is present; it is just one risk factor for CVD and is included in the risk calculation. Statin Choice Patients need to be given information about their absolute risk of CVD and the likely absolute benefits and harms of treatment in ways meaningful to them. (See attached Statins - a guide for patients) The decision to initiate statin therapy should be made after informed discussion between clinician and patient. Pravastatin (up to 40mg) is a third line alternative for primary prevention and Rosuvastatin a third line option for secondary prevention. Unlike atorvastatin and simvastatin, they are not metabolised via P450 CyP3A4 (so no interaction with amiodarone, macrolides, CCBs; diltiazem, verapamil, anti-retrovirals etc). They are hydrophilic rather than lipophilic this may alter side effect patterns but in relation to muscle side effects this is not clear. It is prudent to use lower doses of statins in patients with pre-existing muscle disease. In August 2012, MHRA guidance highlighted the potential interaction between simvastatin and amlodipine and diltiazem and the increased risk of myopathy. Consequently the maximum recommended dose of simvastatin is now 20mg if used in conjunction with either drug. For secondary prevention patients on a drug with potential to interact, a switch from simvastatin 40mg to atorvastatin 10mg is recommended.

3 Atorvastatin has hepatic excretion and is therefore favoured over higher simvastatin doses in patients with impaired kidney function. Atorvastatin 80mg has a similar incidence of myopathy to atorvastatin 10mg but a higher incidence of raised LFTs (2%) (TNT study) Simvastatin 80mg should only be used under exceptional circumstances as it is clearly associated with myopathy side effects. (SEARCH study & MHRA guidance 2010) Please refer to SPCs for more detailed prescribing information on the individual statins. Any statin (even lower doses) is preferred to none as the benefit of monotherapy with Ezetimibe or a fibrate, or the two in combination, instead of statin treatment has a very limited evidence base. Daily dose (mg) Statin 5mg 10mg 20mg 40mg 80mg Atorvastatin 31% 37% 43% 49% 55% Rosuvastatin 38% 43% 48% 53% 58% Simvastatin 23% 27% 32% 37% 42% Fluvastatin 10% 15% 21% 27% 33% Lovastatin _ 21% 29% 37% 45% Pravastatin 15% 20% 24% 29% 33%

4 Statin Treatment Primary Prevention There is little evidence to support aggressive treatment to arbitrary cholesterol targets in primary prevention. NNTs for statins are much higher than for secondary prevention. There is no QOF indicator for cholesterol targets for primary prevention of CVD with statins. Once the patient is on a therapeutic dose of statin (simvastatin or atorvastatin) it is not necessary to escalate treatment to achieve target cholesterol levels in primary prevention of CVD. 1 st line choice simvastatin 40mg or atorvastatin 10mg If patient cannot not tolerate or side effects Consider reduced dose of simvastatin or atorvastatin or switch to pravastatin For primary prevention, NICE guidance gives no specific targets and advocates a fire and forget approach. Repeat lipid measurement is unnecessary. Clinical judgement and patient preference should guide the review of drug therapy and whether to review the lipid profile Secondary Prevention (includes diabetes) 1 st line choice Atorvastatin 40 mg Treatment strategy Treat to target (TC <4mmol/l or LDL-C <2mmol/l) but please note; NICE guidance says to consider intensification of treatment if TC >4mmol/l and also LDL-C >2mmol/l. NICE recognises that this is ambitious and acknowledges that it is not achievable in all cases. Age should be a key factor: the younger the high risk patient, the more ambitious the treatment should be. Decisions on use of statin and intensity of treatment should take into account the patient s informed preference, comorbidities, multiple drug therapy, and the absolute benefit and risks of treatment. For secondary prevention if the patient is taking atorvastatin 40mg, has stopped smoking, is taking aspirin/acei/betablocker & has good BP control, then it is important to consider whether their absolute risk be further reduced by a significant amount by further intensifying therapy. Acute coronary syndromes (ACS) : NICE guidance supports use of atorvastatin 80mg but because of the higher incidence of side effects (see statin choice) a starting dose of atorvastatin 40mg is recommended locally. Titrating up to 80mg atorvastatin can then be done on an individual patient basis. Intensive lipid lowering therapy results in higher discontinuation rates, adverse effects, more drug interactions and requires more monitoring. It is also important to note that single lipid measurements may over or under estimate true lipid levels by around 14%

5 Pt on maximum tolerated dose of statin (80mg atorvastatin can be tried) TC > 4mmol/L and LDL-C > 2mmol/L on a fasting sample (if either target met there is no need to intensify). Adherence assured Clinical decision made to further intensify lipid lowering treatment Are fasting TG > 2.2mmol/L? YES Statin + fenofibrate 200mg od. (avoid max statin dose with fenofibrate). Check lipids at 8 weeks TC > 4 and LDL-C >2 Further advice from lipid clinic ( or referral) NO Continue treatment, monitor as advised TC <4 or LDL-C <2 Statin + ezetimibe 10mg od. Check li- TC > 4 and LDL-C Further advice from lipid clinic ( or Continue treatment, monitor as advised TC <4 or LDL-C <4 Monitoring Baseline Bloods and Clinical Assessment should include: smoking status alcohol consumption blood pressure body mass index or other measure of obesity fasting total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides (if fasting levels are not already available) fasting blood glucose renal function liver function (transaminases) thyroid-stimulating hormone (TSH) if dyslipidaemia is present. For secondary prevention only: lipid profile at baseline, 12 weeks after initiation and then annually. Lipid monitoring is not usually required for primary prevention If a person has acute coronary syndrome, statin treatment should not be delayed until lipid levels are available. A fasting lipid sample should be taken about 3 months after the start of treatment. Creatine kinase should not be routinely monitored in asymptomatic people who are being treated with a statin. In patients with muscle weakness or pain CK should be measured to assess severity of muscle damage and aid decision to continue treatment. If symptoms are tolerable and CK is not raised or is less than 5 times the upper limit of normal, statins may be continued, with frequent monitoring of symptoms and CK, as long as symptoms are not progressive. In patients with CK concentration more than 5 times upper limit or those with rhabdomyolysis, statin therapy should be discontinued immediately. An alternative class of lipid lowering drug may need to be considered or statin therapy could be resumed if benefits seem to outweigh risks. This is rare and expert advice should be sought. Baseline liver enzymes should be measured before starting a statin. Liver function (transaminases) should be measured within 3 months of starting treatment and at 12 months, but not again unless clinically indicated. People who have liver enzymes (transaminases) that are raised but are less than 3 times the upper limit of normal should not be routinely excluded from statin therapy.

6 Statin Intolerance Symmetric muscle ache/muscle fatigue soon after starting statin therapy could be causally related. Elevated CK is sometimes seen (see above). Muscular symptoms of statin therapy may arise after some time of treatment, but is then often associated with some other pathology (weight gain, deterioration of diabetic control, addition of a new medication etc. Try or consider the following approaches: 1. Stop treatment for 2 weeks and rechallenge 2. Try a reduced dose of the alternative preferred statin 3. Switch to pravastatin (primary prevention only) 4. low dose rosuvastatin (5mg alternate days) for high risk patients only For other non-muscular side effects it is reasonable to try a low dose of an alternative before pronouncing true statin intolerance. Other Lipid Regulating Drugs These lipid lowering drugs are all usually initiated for patients with complex dyslipidaemias. They should be reserved for high risk patients who do not get to target cholesterol levels with a statin alone. In general, the evidence for an effect on outcomes is less robust than for statin therapy. Additional monitoring may be required, particularly when used in combination with statins. Further Lipid clinic strategies may include using alternative combinations to those already highlighted or adding fibrates, ezetemibe, colesevelam, or fish oils. Fibrates Fibrates should not be used as first line lipid-lowering drugs for primary or secondary prevention of cardiovascular disease in line with MHRA advice. This follows a risk-benefit review which found only limited data to support a long term clinical benefit from fibrates in these indications. Given the robust evidence for statins for primary and secondary prevention, the use of fibrates should be seen as add-on therapy in secondary prevention and in type 2 diabetes. Fibrate in monotherapy should only be used for type III hyperlipidaemia and for extreme hypertriglyceridaemia with a risk of pancreatitis (specialist care, see Hypertriglyceridaemia guideline) Fenofibrate (200mg caps od) is the fibrate of choice. Emerging evidence suggest specific benefit beyond lipid modification by fenofibrate in type II diabetes (retinopathy). Together with the commonly seen modest hypertriglyceridaemia in type II diabetes, fenofibrate should be seen as the statin add-on priority one therapy Monitoring: The combination of statin plus fibrate does increase the risk of side effects including rhabdomyolysis. Annual monitoring of CK and LFTs is recommended Ezetimibe Ezetimibe lowers cholesterol but there is no clear evidence to show that it produces beneficial clinical outcomes. Ezetimibe is a cholesterol uptake inhibitor and lowers cholesterol to a modest degree (15-20% when prescribed as 10mg monotherapy) If statins are not tolerated (at all, or not at higher doses), or where statins are contra-indicated, ezetimibe may be considered but is not an alternative that is supported by a body of evidence Ezetimibe has no effect on lipid fractions other than LDL-C and should only be used to further reduce LDL-C when the cholesterol targets are not met in secondary prevention. If decision is made to use ezetimibe, a 6 week trial is recommended as there is a wide inter- patient variance in response. If prescribing ezetimibe with a statin, prescribe components separately as it is more cost effective.

7 Colesevalam Colesevalam is a new tablet formulation of anion-exchange inhibitor, and as such it has a good evidence base, although the LDL-C lowering potency is only in the same range as Ezetimibe (15-20%). The drug is not absorbed and works by binding cholesterol and bile acids in the intestine. A small increase in plasma TG is often seen. There is a small but consistent improvement of glycaemic control so the drug could be preferentially used in type 2 diabetes if the TG is not too elevated. Cost is > 1000 per year. Colesevelam should only be used in line with the agreed Oxfordshire Shared Care Protocol. Coenzyme Q Although it has been shown that statin therapy could reduce the skeletal muscle content of Coenzyme Q, there is no evidence base for benefit by supplementing with Coenzyme Q. Statins a guide for patients A guide for patients is also included within the full Oxfordshire CCG Lipid Management Guidance and can be accessed via this link: Oxfordshire CCG Lipid Management Guidance

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