South African Cholesterol Guidelines Compared

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1 South African Cholesterol Guidelines Compared Jacqueline van Schoor, Amayeza Info Centre While infectious diseases are currently the leading cause of death in South Africa, cardiovascular disease (CVD) is not far behind in terms of an important cause of death in our ever-increasingly urbanised population adopting unhealthier lifestyles. Although there are several major risk factors for cardiovascular disease, such as diabetes mellitus, hypertension and central obesity, there is no doubt that dyslipidaemia is a major cause of cardiovascular morbidity and mortality and that lipid-lowering therapy can save lives. number of guidelines on cardiovascular disease prevention A in clinical practice have been issued in recent years by different organisations, both internationally and locally. The South African Lipid Guidelines were published in the South African Medical Journal in 2000 by the South African Medical Association and the Lipid and Atherosclerosis Society of South Africa (LASSA). 2 According to these guidelines: Lipid-lowering drug therapy was recommended for patients with severe genetic dyslipidaemia, established vascular disease and for those at high risk for CVD i.e. a calculated 10-year risk for an acute coronary event 20% The recommended target for low-density lipoprotein (LDL) cholesterol was 3 mmol/l A reduction of at least 45% in LDL-cholesterol level was recommended as a minimum target for patients with severe dyslipidaemia but who were unable to meet the target of 3 mmol/l. The 2000 South African SAMA/LASSA dyslipidaemia guidelines were based on previous American (NCEP II) and European Guidelines, both of which were updated in 2001 (NCEP III) and 2003, respectively. 3,4 The guideline revisions were considered necessary in light of published data from large multicentre clinical trials that conclusively demonstrated the irrefutable benefits of cholesterol lowering for reducing death, myocardial infarction and stroke among patients with established CVD, as well as the beneficial effects of cholesterol lowering for decreasing the incidence of both cardiac and cerebrovascular events in at-risk patients without established CVD. 5 As a result, the indications for lipid-lowering therapy in the international guidelines were expanded to include patients without documented CVD but who are considered at high-risk for CVD (e.g. patients with diabetes mellitus). 5 The need for more aggressive lipid-lowering drug therapy was recognised and LDL-cholesterol goals were lowered to 2.6 mmol/l or even to 2.5 mmol/l in patients at high risk of CVD and in those with established disease. 5 It is expected that both the NCEP III and the 2003 European Guidelines on Cardiovascular Disease Prevention will be revised in late 2010 or early 2011 and it is very likely that the LDL-cholesterol goals will be lowered even further to 2 mmol/l or even 1.8 mmol/l in very high risk patients. The 2006 LASSA revision In 2006, LASSA and the South African Heart Association officially adopted the revised 2003 European guidelines on cardiovascular disease prevention in clinical practice. 1,4 It was acknowledged that limited health care resources in South Africa require lipid-lowering drug therapy to be targeted to those patients at highest cardiovascular risk, a concept supported by the European guidelines. As such, the LDL-cholesterol goals are lower in those with established cardiovascular disease and in those at highest risk. 1 See bullet points below. Cardiovascular disease risk is assessed in the European Guidelines by using the SCORE system. However, since European data may not be applicable to South Africans and until more accurate cardiovascular morbidity and mortality data are available for South Africa, LASSA has recommended that South African health professionals continue using the algorithm based on the Framingham Heart Study to estimate coronary heart disease risk. 1 The 2006 LASSA guide to lipid management in South Africa: Optimum lipid levels and treatment goals 1 Patients with established cardiovascular disease, type 2 diabetes mellitus, type 1 diabetes with microalbuminuria or those 46 SAPJOct10pp46-53.indd 46 10/14/ :39:36 AM

2 REVIEW with severe genetic lipid disorders, such as familial hypercholesterolaemia, are at high risk for a cardiovascular event and require intensive lifestyle intervention and drug therapy. The treatment goals are: Total cholesterol < 4.5 mmol/l LDL cholesterol < 2.5 mmol/l (See LASSA 2006 Revision Chart Category 1) In asymptomatic apparently healthy patients, the decision to start lipid-lowering drug therapy depends not only on the lipid levels but, more importantly, on the assessment of cardiovascular risk. A 10-year risk of non-fatal and fatal coronary heart disease 20% using the Framingham risk score is the cut-off point for intervention. See Framingham chart to calculate cardiovascular risk. The treatment goals for patients taking lipid lowering therapy are: Total cholesterol < 5 mmol/l LDL cholesterol < 3 mmol/l In patients where cardiovascular risk remains high despite lifestyle intervention and initial drug therapy, it may be appropriate to lower treatment goals to those as defined above for patients at high risk. (See LASSA 2006 Revision Chart Category 2) Assessment of CVD risk 1 The 10-year risk of non-fatal and fatal coronary heart disease of 20% as assessed using the algorithm based on the Framingham Heart study is the cut-off point for intervention. (See Chart Category 2). The Council for Medical Schemes Revision The Council for Medical Schemes Guideline for hyperlipidaemia was published in the Government Gazette in Although the Council for Medical Schemes have revised their guideline and have accepted an LDL-cholesterol goal of 2.5 mmol/l, the new guideline is still awaiting approval and as such, the 2003 LDL-cholesterol goal of < 3 mmol/l is still being used. The 2003 guideline as published in the Government Gazette is presented on page 51. The Essential Drug Programme standard treatment guideline for prevention of cardiovascular disease in primary care The Essential Drug Programme for South Africa published revised standard treatment primary health care guidelines in According to these guidelines 7 : All individuals with risk factors for ischaemic heart disease should be encouraged to make lifestyle changes, as appropriate, i.e. maintain ideal weight (body mass index < 25 kg/m 2 ), reduce alcohol intake to no more than two standard drinks per day, stop smoking, follow a prudent eating plan low in fat and high in fibre and unrefined carbohydrates, with adequate fresh fruit and vegetables and to perform regular aerobic exercise e.g. 30 minutes brisk walking three to five times per week. The absolute risk of myocardial infarction over 10 years (in the absence of ischaemic heart disease and monogenetic dyslipidaemia) should be calculated. Lipid-lowering drug therapy is indicated for patients with established cardiovascular disease i.e. ischaemic heart disease, peripheral vascular disease or atherothrombotic stroke. Lipid-lowering drug therapy should be administered in this setting, even if the cholesterol is normal. # Lipid-lowering drug therapy is recommended for patients with diabetes mellitus, even if the cholesterol level is normal. Lipid-lowering drug therapy is recommended for patients at high risk for myocardial infarction (i.e. greater than 20% in 10 years). ## In this group of patients, lipid-lowering drug therapy should only be continued if dyslipidaemia is not corrected with lifestyle modification. Recommended drug therapy should lower cholesterol by at least 25% e.g. simvastatin 10 mg daily. # Normal cholesterol levels are not provided in the guideline, although dyslipidaemia is described as a total cholesterol > 6.5 mmol/l or LDL-cholesterol of > 4 mmol/l. Nonetheless, a total cholesterol of > 5 mmol/l or LDL-cholesterol > 3 mmol/l may be considered acceptable cut-off levels for total and LDLcholesterol, respectively. ## Assessment of risk in the EDL guidelines is based on a calculation which estimates the absolute risk of myocardial infarction over 10 years, in the absence of ischaemic heart disease and monogenetic dyslipidaemia. If the absolute risk of myocardial infarction over the next 10 years is greater than 20%, then lipid lowering therapy is recommended, even if the cholesterol level is normal. 7 The risk assessment in the EDL is not the same as the Framingham risk assessment which calculates the 10-year risk of non-fatal and fatal coronary heart disease. See EDL Risk Assessment for Myocardial Infarction on page 52. Please refer to the Department of Health website for the Standard Treatment Guidelines and Essential Medicines List 2008 for further information. Conclusions Cardiovascular disease remains a major cause of premature death worldwide, including South Africa. Although pharmacists need to encourage lifestyle changes as first-line therapy because healthy eating, weight loss, stopping smoking and regular exercise can reduce cardiovascular risk, it is also important to treat patients with dyslipidaemia to a cholesterol level target in order to reduce cardiovascular risk associated with elevated cholesterol levels. However, the cholesterol target levels as prescribed by guidelines used in South Africa do not appear to be standardised.r 47 SAPJOct10pp46-53.indd 47 10/14/ :39:36 AM

3 16 ESC Guidelines CV Risk Stratification and Cholesterol targets LASSA 2006 Revision Chart Category 1 Framingham CHD Risk >20% Established atherosclerosis 1. Coronary heart disease 2. Cerebrovascular atherosclerotic disease 3. Peripheral vascular disease (equivalent to > 5% CVD mortality risk) Diabetes Type 2 Diabetes Type 1 diabetes with microalbuminuria or proteinuria Genetic dyslipidaemias e.g. Familial hypercholesterolaemia HIGH RISK Goal a No RISK scoring required Total cholesterol < 4.5 mmol/l LDL-cholesterol < 2.5 mmol/l Category 2 b Use Framingham Risk Assessment Tables c : Score: RISK scoring required (Use correct gender table) 1. Age Total cholesterol d Non-smoker/Smoker e HDL-Cholesterol Systolic BP 5. Point total: 10-year CHD event risk % f Initial CHD risk < 20% Initial CHD risk > 20% but reduced to < 20% with lifestyle changes Persistent CHD risk of > 20% despite lifestyle change and initial drug therapy Goal a Goal a Total cholesterol < 5 mmol/l LDL-cholesterol < 3 mmol/l Total cholesterol < 4.5 mmol/l LDL-cholesterol < 2.5 mmol/l 18 ESC Guidelines a Pharmacological treatment required if total-cholesterol and, more importantly, LDL-cholesterol remain above these levels despite lifestyle modification. At present statins are first line drugs for lowering LDL-cholesterol. b Secondary causes of dyslipidaemia should be excluded before progressing to risk assessment (see table on this sheet). c See limitations of Framingham Risk Assessment Score on this page. dtotal cholesterol level is used to assign risk score, but both Total cholesterol and, more importantly, LDL cholesterol are the targets of treatment. ecigarette smoking is defined as: Any cigarette smoking in the last month or a history of 20 cigarettes per day for 10 years (10 pack years). f For persons under the age of 60 years, risk should also be extrapolated to age 60 Limitations of the Framingham Risk Assessment Score charts 1. Patients who are classified in category 1 are high risk and do not require further risk score for management decisions. Other patients who fall into this category include those with severe hypertension (systolic BP >180 mmhg and/or diastolic BP >110 mmhg) or associated target organ damage and those with renal dysfunction. 2. Severe hypercholesterolaemia and hypertriglyceridaemia: The Framingham Risk Assessment chart is only accurate up to total cholesterol values of 7.25 mmol/l and cannot be used for patients with total cholesterol levels above this value. It also does not apply to hypertriglyceridaemia (Triglyceride > 5mmol/l). 3. Family history of early atherosclerotic disease is not taken into account. Clinicians should use their judgment in deciding whether to place a patient with an impressive family history in the high risk category, regardless of their Framingham score, or avoid calculating risk in these patients. 4. Hypertriglyceridaemia, impaired glucose tolerance and abdominal obesity are not taken into account in the risk score, despite these factors being important risk factors for CVD. Patients with features of the metabolic syndrome should be considered to be at higher risk and treated accordingly. 5. Women are assigned a lower risk than men. Physicians should exercise their clinical judgment and elevate the risk assessment if the patient has other risk factors for CVD or a strong family history of CVD. 6. Ethnicity: The Framingham Risk assessment charts are based on epidemiological data from a Caucasian North American population. Care should be advised when applying them to other patient populations and race groups. Physicians should exercise their clinical judgment in these patients. Secondary causes of dyslipidaemia 1. Diabetes mellitus 2. Hypothyroidism 3. Liver disease 4. Renal disease 5. Alcohol excess 6. Drugs Progestins Steroids Antiretroviral agents Retinoids Conversion from mg/dl Cholesterol: mmol/l=mg/dl x mg/dl = mmol/l x 38.7 Triglyceride: mmol/l=mg/dl x Mg/dl = mmol/l x 88.5 LDL-Cholesterol: Low Density Lipoprotein Cholesterol; HDL-C: High Density Lipoprotein Cholesterol; TG: Triglyceride; CHD: Coronary Heart Disease; CVD: Cardiovascular Disease; BP: Blood Pressure The Lipid Advisory Panel has been sponsored by an unrestricted educational grant from AstraZeneca (Pty) Ltd South Africa. 48 SAPJOct10pp46-53.indd 48 10/14/ :39:46 AM 14945

4 Framingham 10-year Risk Assessment Chart Estimate of 10-year risk for MEN: (Framingham point scores) Age (yr) Total Cholesterol (mmol/l) Age: < ! HDL (mmol/l) Age: Nonsmoker Smoker ! <1 2 Systolic BP (mmhg) If untreated If treated < ! Estimate of 10-year risk for WOMEN: (Framingham point scores) Age (yr) Total Cholesterol (mmol/l) Age: < ! HDL (mmol/l) Age: Nonsmoker Smoker ! <1 2 Systolic BP (mmhg) If untreated If treated < ! Point total 10-year risk % Point total 10-year risk % 10-year risk % < 0 < ! 17! year risk % < 9 < ! 25! 30 Framingham scoring system for calculating the 10-year risk of major coronary events in adults without diabetes. HDL denotes high-density lipoprotein cholesterol & BP blood pressure. All age ranges are given in years. Reprinted from National Institutes of Health, National Heart, Lung & Blood Institute. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High blood Cholesterol in Adults (Adult Treatment Panel III). Executive Summary. NIH Publication No ; May SAPJOct10pp46-53.indd 50 10/14/ :39:47 AM

5 REVIEW Council for Medical Schemes 2003 Guideline* * At the time of print the revised guideline from the Council for Medical Schemes was not yet approved. 51 SAPJOct10pp46-53.indd 51 10/14/ :39:50 AM

6 The EDL Risk Assessment for Myocardial Infarction Section A: Men Age (years) Section B: Women Age (years) Total cholesterol Total cholesterol < 4.1 mmol/l 3 < 4.1 mmol/l > > References 1. Raal FJ, Marais AD, Schamroth C. Adoption of the European guidelines on cardiovascular disease prevention in clinical practice guide to lipid management. SA Heart 2006:1 20. July. 2. South African Medical Association and Lipid and Atherosclerosis Society of Southern Africa working group. Diagnosis, management and prevention of the common dyslipidaemias in South Africa Clinical Guideline. S Afr Med J 2000;90: Expert Panel on detection, evaluation and treatment of high cholesterol in adults. Executive summary of the third report of the National Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001;285: De Backer G, Ambrosioni E, Borch-Johnson K, et al. European Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2003;24: Raal FJ, Schamroth C, Klug E, Mills P. The South African Lipid Guidelines: Is there a need for an update? Cardiovascular J S Afr 2004;15(2): Hyperlipidaemia. Government Gazette No October Department of Health. Primary Health Care. Standard Treatment Guidelines and Essential Medicines List. Essential Drug Programme. South Africa HDL cholesterol < 0.91 mmol/l > Blood pressure* < 120 / < / / / / Other Non-smoker 0 Smoker 2 Not diabetic 0 Diabetic 2 HDL cholesterol < 0.91 mmol/l > Blood pressure* < 120 / < / / / / Other Non-smoker 0 Smoker 2 Not diabetic 0 Diabetic 4 * Use the highest reading of either diastolic or systolic pressure (mmhg). Section C: Risk (% of cohort defi ned by the score who will have a myocardial infarction in 10 years) Total points Men (%) >53 Women (%) >27 The score is gender dependent: for example, 6 points for men and 10 for women both have a 10% risk. 52 SAPJOct10pp46-53.indd 52 10/14/ :39:55 AM

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