Lipid Modification

Quality:MK Quality:MK Lipid Modification Prescribing Toolkit By Jas Janjuha Quality MK Clinical Effectiveness Pharmacist Supporting Primary Care Clinicians to adopt an evidence-based approach to Lipid Modification health:mk April 09 1 Title Description Lipid Modification Prescribing Toolkit A toolkit to support an evidence based approach to lipid modification in primary care, including background clinical information, the evidence base, patient letters, flowchart and poster consolidating latest NICE guidelines. Primary care clinicians across Milton Keynes PCT July 2009, v2.1 Target Audience Date of issue & Version Number Review date Created by July 2010 Jas Janjuha MSc, MRPharmS, Quality MK Clinical Effectiveness Pharmacist, Jas.janjuha@miltonkeynes.nhs.uk Approved /ratified by Sponsored by Available from Janet Corbett, Chief Pharmacist, Milton Keynes PCT Quality MK programme Anne Gray, Commissioning Librarian NHS Milton Keynes Sherwood Place Sherwood Drive Bletchley Milton Keynes MK3 6RT Commissioning.librarian@miltonkeynes.nhs.uk Online at: www.qualitymk.nhs.uk Jas Janjuha Jas.janjuha@miltonkeynes.nhs.uk Feedback to Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 2 of 19 Table of Contents Table of Contents ................................................................................................................................3 Introduction.........................................................................................................................................4 Summary of Evidence Base .................................................................................................................4 Clinical Considerations when switching from atorvastatin to simvastatin .........................................5 Key trials ..............................................................................................................................................6 Bibliography.........................................................................................................................................9 Simvastatin Patient Information Leaflets ..........................................................................................10 Patient Decision Aid ..........................................................................................................................10 Patient sample letters .......................................................................................................................11 Standard Operating Procedure for Switching Atorvastatin 10mg and 20mg to Simvastatin 40mg .14 Statin induced myopathy – overview and management ..................................................................15 Poster which includes flowchart, key messages & patient decision aid ...........................................18 Flowchart consolidating NICE Guidance CG 67 & 71 ........................................................................19 Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 3 of 19 Introduction This toolkit has been produced to help support an evidence based approach to lipid modification. It contains background clinical information, the evidence base, patient letters, a standard operating procedure (SOP), flowchart and poster consolidating the latest NICE guidelines (endorsed by Dr Asif Ali, Consultant in Diabetology and Endocrinology, Milton Keynes Hospital NHS Foundation Trust) and information on the use of a patient decision aid. Summary of Evidence Base Current national NICE guidelines1 2 recommend simvastatin 40mg as first line choice for primary and secondary prevention of cardiovascular disease. The Framingham equation should be used to assess CV risk in people without established disease, within a systematic strategy to identify people aged over 40 at high risk. Lipid management should be only part of the strategy to reduce risk, along with smoking cessation, healthy eating, exercise, and other modifiable risk factors. In primary prevention no specific target levels are advocated (i.e. a “fire and forget” approach). In secondary prevention, simvastatin 80mg may be considered where total cholesterol does not fall below 4mmol/l. It must be remembered that more than 50% of patients will not fall below 4mmol/l. Aggressive target chasing with more expensive statins is not cost-effective and therefore not recommended. Patients with acute coronary syndrome should be offered high intensity statins, but note that no targets are recommended. 1 National Institute for Health and Clinical Excellence. Lipid modification. Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. Clinical Guideline 67. May 2008. http://www.nice.org.uk/Guidance/CG67 2 National Institute for Health and Clinical Excellence. Identification and management of familial hypercholesterolaemia. Clinical Guideline 71. August 2008. http://www.nice.org.uk/Guidance/CG71 Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 4 of 19 Clinical Considerations when switching from atorvastatin to simvastatin  Using information available from the Curves study (summary on page 6), comparing potency of the various statins, simvastatin 40mg produces a 32% fall in total cholesterol (40% fall in LDL) compared to atorvastatin 10mg which produces a 28% fall in total cholesterol (38% fall in LDL). Simvastatin 40mg also has the greatest amount of clinical evidence to support its use of all the statins, both in terms of safety and efficacy, including one of the earliest landmark studies, the 4S(summary on page 7), and, more recently, the Heart Protection Study (summary on page 8). GPs can therefore be confident that this switch should not deteriorate cholesterol control in their patients, which would obviously be a concern clinically and in terms of QOF. Simvastatin should always be taken at night and it is vital that this instruction is clear on the prescription (atorvastatin is the only statin that can be taken at any time of day due to its long half-life). The dose of simvastatin should not exceed 20mg daily in patients receiving concomitant medication with amiodarone, verapamil or diltiazem due to an increased risk of myopathy and rhabdomyolysis. Patients taking any of these drugs should not be switched. The SPC for simvastatin advises against use with with fibrates, nicotinic acid (although these combinations sometimes do occur, usually under specialist supervison) or cyclosporin, because of the increased risk of myopathy. Patients taking atorvastatin concurrently with fibrates, nicotinic acid or cyclosporin should be excluded from the switch. Other patients who should also be excluded from the switch are detailed in the Standard Operating Procedure. Dose titration. It is recommended that patients are switched directly to 40mg and that they are not titrated up from 10mg. If this is done there is a possibility that some patients may inadvertently remain on a dose that is too low. More importantly, in the Heart Protection Study, over 10,000 patients were put straight on to 40mg simvastatin, without dose titration, yet the annual rate of myopathy was 0.01% (and this was in patients not previously exposed to a statin). It is recommended that all patients switched to simvastatin have a follow up blood test 3 months after the switch occurs to check LFTs and total cholesterol.          Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 5 of 19 Key trials Curves Study Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study). Am J Cardiol. 1998 Mar 1;81(5):582-7. TYPE OF TRIAL: Multicenter, randomized, open-label, parallel-group AIM of trial: To evaluate the comparative dose efficacy of the statins: atorvastatin 10, 20, 40, and 80 mg compared with simvastatin 10, 20, and 40 mg, pravastatin 10, 20, and 40 mg, lovastatin 20, 40, and 80 mg, and fluvastatin 20 and 40 mg. PATIENT SELECTION: 534 hypercholesterolemic patients (low-density lipoprotein [LDL] cholesterol > or = 4.2 mmol/L and triglycerides < or = 4.5 mmol/L). DURATION OF TRIAL: 8-week study EFFICAY END POINTS: Mean percent change in plasma LDL cholesterol (primary), total cholesterol, triglycerides, and high-density lipoprotein cholesterol concentrations from baseline to the end of treatment. SAFETY: All statins studied had similar tolerability. There were no incidences of persistent elevations in serum transaminases or myositis. BOTTOM LINE: Simvastatin 40mg produces a 32% fall in total cholesterol (40% fall in LDL) compared to atorvastatin 10mg which produces a 28% fall in total cholesterol (38% fall in LDL). Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 6 of 19 Scandiandian Simvastatin Survival Study Trial The Scandinavian Simvastatin Survival Study Group. Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344:1383-1389. Type of trial: Double-blind RCT AIM of trial: To determine whether simvastatin can reduce cardiovascular events in those with established coronary heart disease (angina or myocardial infarction and raised cholesterol) PRIMARY OUTCOME: Effect on total mortality SECONDARY OUTCOME: Time to major coronary events PATIENT SELECTION: 4444 patients with angina pectoris or previous myocardial infarction and serum cholesterol 5.5-8.0 mmol/L on a lipid-lowering diet were randomized to double-blind treatment with simvastatin (20-40mg)or placebo. DURATION OF TRIAL: 5.4 years SAFETY: Few adverse effects. RESULTS: Simvastatin produced mean changes:    Total cholesterol -25% Low-density-lipoprotein cholesterol -35% and High-density-lipoprotein cholesterol of +8%. Outcomes Coronary death All major coronary events Non-fatal MI Need for coronary revascularisation Relative Risk Reduction 42% 34% 37% 37% BOTTOM LINE: The first landmark statin trial and the first to demonstrate a statistically significant reduction in overall mortality secondary to lipid intervention (simvastatin) ie long-term treatment with simvastatin is safe and improves survival in CHD. Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 7 of 19 Heart Protection Study Heart Protection Study (HPS) Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebocontrolled trial. Lancet. 2002; 360 (9326):7-22. TYPE OF TRIAL: RCT AIM of trial: To determine the effect of simvastatin 40mg on morbidity and mortality of high risk adults PATIENT SELECTION: 20,536 UK adults (aged 40-80 years) with coronary disease, other occlusive arterial disease, or diabetes DURATION OF TRIAL: Mean of 5-years PRIMARY OUTCOME: Mortality and fatal or non-fatal vascular events SECONDARY OUTCOME: Major coronary and vascular events, such as stroke RESULTS: ENDPOINTS Coronary death Non-fatal MI Any stroke Any revascularisation Any major vascular event Simvastatin 5.7% 3.5% 4.3% 9.1% 19.8% Placebo 6.9% 5.6% 5.7% 11.7% 25.2% Ie Baseline risk over 5yrs NNT 5yrs 83 48 71 38 19 Derived from HPS, Lancet 2002;360:7-22 SAFETY: The annual excess risk of myopathy with this regimen was about 0.01%. There were no significant adverse effects on cancer incidence or on hospitalisation for any other non-vascular cause. BOTTOM LINE: “30% reduction in MI, stroke, revascularisation procedure or other major vascular event irrespective of cholesterol level (or age, or gender, or other treatments)”. Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 8 of 19 Bibliography 1. Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study). Am J Cardiol. 1998 Mar 1;81(5):582-7. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/9514454 2. Heart Protection Study (HPS) Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebocontrolled trial. Lancet. 2002; 360 (9326):7-22. Abstract: http://www.ncbi.nlm.nih.gov/pubmed/12114036 3. MeReC Bulletin. Lipid-modifying treatment. December 2008. Volume 19 No 3. http://www.npc.co.uk/ebt/merec/cardio/cdlipids/merec_bulletin_vol19_no3.html 4. National Institute for Health and Clinical Excellence. Identification and management of familial hypercholesterolaemia. Clinical Guideline 71. August 2008. http://www.nice.org.uk/Guidance/CG71 5. National Institute for Health and Clinical Excellence. Lipid modification. Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. Clinical Guideline 67. May 2008. http://www.nice.org.uk/Guidance/CG67 6. The Scandinavian Simvastatin Survival Study Group. Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344:1383-1389. Abstract:http://www.ncbi.nlm.nih.gov/pubmed/7968073 7. Sathasivam S , Lecky B. Statin induced myopathy. (Review) BMJ 2008 Nov;337:a2286 Copies of these articles are available on the Quality MK website www.qualitymk.nhs.uk or from Anne Gray Commissioning.librarian@miltonkeynes.nhs.uk (Milton Keynes PCT staff only) Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 9 of 19 Simvastatin Patient Information Leaflets Click on icon to access Milton Keynes PCT Patient Information Leaflet SIMVASTATIN SIMVASTATIN.pdf Primary prevention.pdf Copies available on the Quality MK website www.qualitymk.nhs.uk or from Anne Gray Commissioning.librarian@miltonkeynes.nhs.uk (Milton Keynes PCT staff only) Patient Decision Aid This may be used by health care professionals during consultations with patients to clarify visually the absolute benefits and harms of taking a statin at standard doses eg simvastatin 40mg, based on their baseline risk of having a cardiovascular event. National Prescribing Centre. Using patient decision aids. MeReC Extra 2008; No. 36 http://www.npci.org.uk/therapeutics/cardio/cdlipids/resources/pda_Lipids.pdf Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 10 of 19 Patient sample letters Atorvastatin to simvastatin switch and FAQs (Please use practice headed paper) Date Dear We have recently been reviewing patient’s medication records as part of our ongoing effort to provide the best patient care. There has been an alteration to your repeat prescription. The Atorvastatin 10mg tablets, which you used to take to reduce your cholesterol, have been changed to an alternative similar medication called Simvastatin 40mg tablets. These tablets must be taken “ONE tablet at NIGHT”. The dose of Simvastatin is different to the Atorvastatin, but it is equivalent and will be as, if not more, effective at reducing your cholesterol. Please book an appointment with your surgery to have a Liver Function and Cholesterol blood test when you have been taking the new tablets for 3 months. This is a fasting (starving) blood test. Please use up any remaining atorvastatin tablets before starting your new prescription for simvastatin. The Primary Care Trust, along with your Doctor’s Practice, has decided to change this medication due to the significant reduction in cost of this medicine to the NHS. The money saved will be used to invest in other local health services for patients like you. Any changes to patient’s prescriptions are made after careful consideration of each patient’s medical record and therefore the change will not apply to all patients. If you have any queries about this, please contact your pharmacy, surgery or speak to your doctor. Yours sincerely Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 11 of 19 Frequently Asked Questions Why Is My Medicine Being Changed? As a result of negotiations by the Department of Health there has been a very substantial reduction in the price of simvastatin, a well-established and clinically effective alternative to atorvastatin. This has led to a decision to prescribe simvastatin by all general practices throughout Milton Keynes Primary Care Trust and Milton Keynes General Hospital. What Is The Difference Between These Two Medicines? Atorvastatin and simvastatin have both been available for many years work in exactly the same way and result in the same cholesterol-lowering effect. The only difference is that they are manufactured by two different pharmaceutical companies whose prices vary. Will The New Tablets Cause More Side-Effects? It is highly unlikely that this will happen. Simvastatin was actually the first medicine of this type to be introduced and has a very good safety record – so much so, that lower doses are available without a doctor’s prescription. All the medicines in this class can very occasionally cause unexplained muscle pain – if this happens you should tell your doctor. Why Is A Simvastatin 40mg Tablet, Compared With A 10mg Atorvastatin Tablet? Although both drugs reduce cholesterol, to get the same effect from simvastatin as you do with atorvastatin, you need to take a 40mg tablet. Do I Have To Take The Simvastatin At Night? Yes, in order for simvastatin to work effectively it needs to be taken at night. This can be at any time from about 6pm onwards; maybe after your evening meal or when you go to bed, depending on when it’s easiest for you to remember. Is There Anything Else I Need To Know? Grapefruit juice can affect the way that simvastatin works and so should be avoided at the same time. Remember, if you have any other queries or concerns please ask, either at the surgery or the pharmacy, when you have your prescription dispensed. Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 12 of 19 Titrating up from simvastatin 10mg to 40mg (Please use practice headed paper) Date Dear «PATIENT_Title» «PATIENT_Surname» We have been reviewing your medication as part of a continual effort to provide the best possible care and treatment for our patients. You will notice the next time you collect your prescription for your cholesterol lowering tablet simvastatin, it has been changed from 10mg “one tablet taken at night” to 40mg “one tablet taken at night”. This is because the higher strength has been shown to be more effective at reducing your risk of having a heart attack or stroke. Approximately 3 months after you start taking the increased dose of simvastatin tablets we would like you to make an appointment with our Health Care Assistant to have a blood test to check your cholesterol level and liver function. This is a fasting (starving) blood test. Please use up any remaining lower strength simvastatin tablets before starting your new prescription. Should you have any queries please contact the pharmacy, surgery or speak to your doctor. Thank you, Yours sincerely On behalf of the doctors at ...................... Surgery Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 13 of 19 Standard Operating Procedure for Switching Atorvastatin 10mg and 20mg to Simvastatin 40mg 1. A search on the Practice computer is carried out on all patients prescribed Atorvastatin 10mg 2. Using individual patient records, ensure that the patient has not taken Simvastatin previously and has stopped due to a side effect or adverse reaction. These patients should be exempt from the switch. 3. Using individual patient records, ensure that the patient has not been prescribed Atorvastatin so that the dose can be taken in the morning rather than at night due to insomnia or concordance issues. These patients should be exempt from the switch. 4. Using individual patient records, ensure that the patient doesn’t also take (also see Appendix 1 of the BNF):  Amiodarone  Antibacterials – Clarithromycin, Erythromycin, Telithromycin, Fusidic Acid (oral)  Warfarin  Antifungal – Itraconazole, Ketoconazole  Antiviral (HIV) medications  Calcium Channnel Blockers – Diltiazem, Verapamil  Ciclosporin  Fibrates  Ezetimibe  Nicotinic acid These patients should be excluded from the switch. 5. Ensure GP authorisation for each patient switch. 6. Change Atorvastatin 10mg to Simvastatin 40mg on the repeat prescribing record (Simvastatin 40mg Heart Protection Study evidence) and make a note on the patient record stating this. 7. Send a letter (please feel free to adapt the sample letter) to the patient stating that the change has been made and the reasons as to why. 8. Note in the records that the patient needs to have their Liver Function Tests (LFTs) and cholesterol checked after 3 months of taking the Simvastatin. Liaise with relevant practice staff regarding the organisation of this. 9. Inform the local community pharmacy and/or GP dispensary about the change but stress that not all patients will be changed to simvastatin, especially if they are concerned about their stock holding of atorvastatin. Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 14 of 19 Statin induced myopathy – overview and management The following is based on an article published in the BMJ (Sivakumar Sathasivam and Bryan Lecky. Statin induced myopathy. BMJ 2008 Nov;337:a2286) and gives an overview of statin induced myopathy and its management. How common is statin induced myopathy? In one large, population based cohort study of patients from general practices in the United Kingdom between 1991 and 1997, the mean incidence of myopathy (defined in this trial as muscle weakness and raised concentrations of creatine kinase) in patients taking statins was 1.2 per 10,000 person years (95% confidence interval 0.3 to 4.7). What is the clinical spectrum of statin induced myopathy? The clinical spectrum of statin induced myopathy includes myalgia, myositis, rhabdomyolysis, and an asymptomatic increase in the concentration of creatine kinase. Muscle related adverse events can be difficult to describe because the terminology used is inconsistent, but the proposed definitions in the table provide a useful guide. The term myopathy is often used to include the entire spectrum of muscle related adverse events (as in this article), but other definitions are common, especially when the term is used in clinical trials. Terminology Myalgia Myositis Definition Muscle pain or weakness without raised CK Muscle symptoms with raised CK, typically less than 10 times the upper limit of normal Muscle symptoms with markedly raised CK, typically more than 10 times the upper limit of normal Raised CK without muscle symptoms Rhabdomyolysis Asymptomatic raised creatine kinase What are the clinical features of statin induced myopathy? Symptoms of statin induced myopathy include fatigue, muscle pain, muscle tenderness, muscle weakness, nocturnal cramping, and tendon pain. The muscle symptoms tend to be proximal, generalised, and worse with exercise. In a small retrospective study of 45 patients, the mean duration of statin therapy before onset of symptoms was 6.3 (SD 9.3) months (range 1 week to 4 years). In this study, the mean duration of myalgia after stopping statin therapy was 2.3 (SD 3.0) months (range 1 week to 4 months). Muscle symptoms that develop in a patient who has been taking statins for several years are unlikely to have been caused by these drugs. What are the risk factors for statin induced myopathy? Evidence from well designed randomised controlled trials shows that myopathy correlates most closely with dose of statins and is independent of reductions in low density lipoprotein cholesterol. Several risk factors have been proposed, mainly by experts on the basis of published evidence (box 1). No clear data are available about the relative risks associated with individual factors, since the dose, and possibly the type, of statin affects the risk of precipitating myopathy. Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 15 of 19 Any factor that increases the serum concentration of a statin has the potential to increase the risk of myopathy. Therefore, factors that affect the pharmacokinetics of statins, leading to increased concentrations of the drugs in blood or tissue, may predispose to myopathy. Is measuring creatine kinase necessary before starting statin therapy and during treatment? NICE Guidance suggests that creatine kinase should not be routinely monitored in asymptomatic people who are being treated with a statin. People who are being treated with a statin should be advised to seek medical advice if they develop muscle symptoms (pain, tenderness or weakness). If this occurs, creatine kinase should be measured. How is statin induced myopathy managed? If a patient’s history, physical examination, and creatine kinase measurements show features of statin induced myopathy, first line management is to stop statins, observe symptoms, and monitor creatine kinase. A repeat challenge with statins may be attempted to assess whether features of statin induced myopathy return; many patients with myalgia or myositis will tolerate reintroduction of the same statin, preferably at a lower dose, after symptoms resolve. If muscular symptoms are tolerable and creatine kinase is not raised, or is less than 10 times the upper limit of normal, statins may be continued, with frequent monitoring of symptoms and creatine kinase, as long as symptoms are not progressive. In patients with tolerable muscle related problems and creatine kinase concentration more than 10 times the upper limit of normal, or in those with rhabdomyolysis, statin therapy should be discontinued and its risks and benefits should be assessed. An alternative class of lipid lowering drug might need to be considered, or statin therapy could be resumed if the benefits seem to outweigh the risks. Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 16 of 19 Factors that may increase the risk of statin induced myopathy         Advanced age (>80 years old) Female sex Advanced age (>80 years old) Low body mass index Multisystem diseases (for example, diabetes mellitus) Diseases affecting kidney or liver function Hypothyroidism (untreated) Drug interactions, especially with drugs that are inhibitors or substrates of the cytochrome P450 pathway (for example, fibrates, nicotinic acid, calcium channel blockers, ciclosporin, amiodarone, thiazolidinediones, macrolide antibiotics, azole antifungals, protease inhibitors, warfarin) Vigorous exercise Excess alcohol Intercurrent infections Major surgery or trauma Diet (excessive grapefruit or cranberry juice) Genetic factors (for example, polymorphisms of the cytochrome P450 isoenzymes or drug transporters, inherited defects of muscle metabolism, traits that affect oxidative metabolism of fatty acids) Diagnosis and management of statin induced myopathy       TIPS  Slightly increased creatine kinase is common in the general population  Myopathy that develops after a patient has been taking statins for several years is unlikely to have been caused by these drugs  Statin-induced myopathy correlates most closely with the dose of statins, but any factor that increases the serum concentration of a statin potentially increases the risk of myopathy  If a patient presents with features suggesting statin induced myopathy, first line management is to stop statin therapy and observe any effect on symptoms and concentration of creatine kinase   Thyroid stimulating hormone should be checked in patients on statins who develop a myopathy because hypothyroidism is a common cause of hypercholesterolaemia and raised creatine kinase If muscle-related symptoms or raised creatine kinase concentrations persist after statin therapy is stopped, consider Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 17 of 19 Poster which includes flowchart, key messages & patient decision aid (A3 version available on request) Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 18 of 19 Flowchart consolidating NICE Guidance CG 67 & 71 Prescribing strategies for lipid modification in adults Baseline lipids & LFTs (rpt LFTs at 3 & 12 months only unless clinically indicated) Pharmacological therapy (in conjunction with lifestyle advice)  Exclude any contraindications and secondary causes (e.g. renal, TFTs).  Baseline full, fasting lipid profile, LFTs (rpt at 3 & 12 months only unless clinically indicated).  Initiate Simvastatin 20-40mg at night or  Pravastatin 20-40mg at night if prescribed warfarin or other interacting medicines (see BNF for details)  Use audit level to guide treatment: TC<5.0, LDL<3 Lifestyle Advice Include where needed:  Smoking cessation  Exercise  Dietary advice  Alcohol reduction  Weight management Optimise management of other modifiable risk factors Simvastatin 40mg at night (or pravastatin if interacting medicines) Primary Prevention* Secondary Prevention including Type 2 Diabetes Mellitus “Dose & dump” strategy If TC >4 or LDL>2 If statin intolerance If TC >7.5 or LDL>4.9 *At high risk: primary prevention of Check compliance & concordance Depending on severity of side effects:  S/Es may be transient. Stop & rechallenge statin.  Try reducing dose or  Another statin or  Ezetimibe / fibrate / anion exchange resin or  Seek advice  Consider increasing to simvastatin 80mg at night taking into account, concordance, co-morbidities, polypharmacy, absolute benefit & risks  Consider higher intensity statin or ezetimibe in Type 2 diabetes (Recognise that 50% patients will not achieve 4/2; NICE do not recommend aggressive target chasing).  In Acute Coronary Syndrome do not delay high intensity statin until lipid levels are available Familial hypercholesterolaemia:  Offer referral to a specialist or seek advice CVD for adults >40 with 20% or greater risk of developing CVD within 10 years (based on Framingham 1991 risk calculator or if this is not available for certain groups of people, by clinical assessment. e.g. diabetics, high risk ethnic groups, familial dyslipidaemia). Lipid Modification Prescribing Toolkit, v2.1 July 2009 Page 19 of 19