NEW LIPID GUIDELINES:WHAT HAS CHANGED? ASSOC.PROF.DR. OKAN GULEL ONDOKUZ MAYIS UNIVERSITY FACULTY OF MEDICINE CARDIOLOGY DEPARTMENT SAMSUN, TURKEY Novel/Important Aspects-1 Treatment of dyslipidemia should not be considered as an isolated process, but rather within the context of integrated prevention of cardiovascular disease in each patient →the SCORE system Anguita M, et al. Rev Esp Cardiol. 2011 Dec;64(12):1090-5. SCORE Scale The preference for the SCORE system over other risk scales is based on the fact that it was designed and evaluated using representative European cohorts. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. SCORE Scale The SCORE scale allows for estimating the 10-year risk of the first fatal atherosclerotic complication based on the following risk factors: Age Gender Smoking Systolic blood pressure Total cholesterol ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. SCORE Scale Charts for high and low risk regions in Europe. The low risk charts→in Belgium, Germany, Finland, France, Greece, Italy, Spain, Denmark, The Netherlands, United Kingdom, Sweden, Norway, Iceland, Ireland, Austria, Malta, Portugal, Slovenia, Monaco, San Marino. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. SCORE Scale The high risk charts→in Bulgaria, Macedonia, Russia, Moldova, Ukraine, Belarus, Latvia. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. SCORE Scale SCORE database has shown that HDL-C modifies risk at all levels of risk as estimated from the SCORE cholesterol charts. Risk will be higher than indicated in the charts in individuals with low HDL-C. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. SCORE Scale Risk will also be higher than indicated in the charts in; *Socially deprived individuals *Sedentary subjects and those with central obesity *Individuals with diabetes *Individuals with low apo A1, increased triglyceride, fibrinogen, homocysteine, apo B, and lipoprotein(a) levels, familial hypercholesterolaemia, or increased hs-CRP *Asymptomatic individuals with preclinical evidence of atherosclerosis *Those with impaired renal function *Those with a family history of premature CVD ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. SCORE Scale A particular problem relates to young people with high levels of risk factors. Although the absolute SCORE risk can be low in young patients, if several risk factors are present, the relative risk will be high. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Risk Levels Very High Risk: A calculated SCORE ≥10% Documented CVD by invasive or non-invasive testing Type 2 diabetes, type 1 diabetes with target organ damage Moderate to severe CKD ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Risk Levels High Risk: A calculated SCORE ≥5 to <10% Markedly elevated single risk factors Moderate Risk: A calculated SCORE ≥1 to <5% Low Risk: A calculated SCORE <1% ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Intervention Strategies ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Novel/Important Aspects-2 Recommendations for lipid analysis as treatment targets in the prevention of CVD and strengthening of strict LDL cholesterol targets for patients with very high, high, and intermediate risk levels Anguita M, et al. Rev Esp Cardiol. 2011 Dec;64(12):1090-5. Treatment Targets • LDL-C→recommended as target for tx (class I A) • TC→considered as tx target if other analyses are not available (class IIa A) • TG→analysed during the tx of dyslipidaemias with high TG levels (class IIa B) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Treatment Targets • Non-HDL-C→considered as a secondary tx target (class IIa B) • Apo B→considered as a secondary tx target (class IIa B) • HDL-C or the ratios→not recommended as targets for tx (class III C) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Treatment Targets for LDL-C • In patients at VERY HIGH CV risk→the LDL-C goal is <1.8 mmol/L (<~70 mg/dL) and/or ≥50% LDL-C reduction when target level can not be reached (class I A) • In patients at HIGH CV risk→the LDL-C goal <2.5 mmol/L (<~100 mg/dL) should be considered (class IIa A) • In patients at MODERATE CV risk→the LDL-C goal <3.0 mmol/L (<~115 mg/dL) should be considered (class IIa C) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Treatment Targets Other Than LDL-C • If non-HDL-C is used, the targets should be; <2.6 mmol/L (<~100 mg/dL) in those at VERY HIGH CV risk and <3.3 mmol/L (<~130 mg/dL) in those at HIGH CV risk (class IIa B) • If apo B is available, the targets are; <80 mg/dL in those at VERY HIGH CV risk and <100 mg/dL in those at HIGH CV risk (class IIa B) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Novel/Important Aspects-3 Choice of lipid-lowering drugs in the management of dyslipidaemias Anguita M, et al. Rev Esp Cardiol. 2011 Dec;64(12):1090-5. Pharmacological Treatment of Hypercholesterolaemia • Statin→prescribe up to the highest recommended dose or highest tolerable dose to reach the target level (class I A) • Statin intolerance→bile acid sequestrants or nicotinic acid (class IIa B) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Pharmacological Treatment of Hypercholesterolaemia • Statin intolerance→a cholesterol absorption inhibitor, alone or in combination with bile acid sequestrants or nicotinic acid (class IIb C) • Target level is not reached→statin combination with a cholesterol absorption inhibitor or bile acid sequestrants or nicotinic acid (class IIb C) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Pharmacological Treatment of Hypertriglyceridaemia ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Drugs Affecting HDL-C Nicotinic acid→the most efficient drug to raise HDL-C and should be considered (class IIa A) Statins and fibrates→raise HDL-C with similar magnitude and may be considered (class IIb B) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Drug Combinations for the Management of Mixed Dyslipidaemias • ↑ in HDL-C and ↓ in TG on top of ↓ in LDL-C can be achieved by statins. • Statin+nicotinic acid→the adverse effect of flushing may affect compliance • Statin+fibrate→monitor for myopathy; combination with gemfibrozil should be avoided • TG are not controlled by statins or fibrates→n3 fatty acids to decrease TG further ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Novel/Important Aspects-4 Detailed description of treatment targets and prescriptions in special clinical situations Anguita M, et al. Rev Esp Cardiol. 2011 Dec;64(12):1090-5. Management of Dyslipidaemias in Different Clinical Settings Familial dyslipidaemias Children Women The elderly Metabolic syndrome and diabetes mellitus Patients with acute coronary syndrome and patients undergoing percutaneous coronary intervention Heart failure and valvular disease Autoimmune diseases Renal disease Transplantation patients Peripheral arterial disease Stroke Human immunodeficiency virus patients ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Diabetes Mellitus Type 1 DM and in the presence of microalbuminuria and renal disease LDL-C lowering (at least 30%) with statins as the first choice (eventually drug combination) irrespective of the basal LDL-C concentration (class I C) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Diabetes Mellitus ●Type 2 DM+CVD or CKD ●Type 2 DM without CVD+age>40 years+≥1 other CVD risk factors or markers of target organ damage ●Primary goal for LDL-C is <1.8 mmol/L (<~70 mg/dL) ●Secondary goal for non-HDL-C is <2.6 mmol/L (~<100 mg/dL) and for apo B is <80 mg/dL (class I B) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Diabetes Mellitus Type 2 DM ●LDL-C <2.5 mmol/L (<~100 mg/dL) is the primary target ●Non-HDL-C <3.3 mmol/L (<~130 mg/dL) and apo B <100 mg/dL are the secondary targets (class I B) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Moderate to Severe Chronic Kidney Disease Primary target of therapy→LDL-C reduction LDL-C lowering ↓ CVD risk in CKD patients Statins→slow the rate of kidney fx loss modestly and thus protect against the development of ESRD requiring dialysis (class IIa C) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Moderate to Severe Chronic Kidney Disease Statins→beneficial effect on pathological proteinuria (>300 mg/day); considered in stage 2-4 CKD patients (class IIa B) Statins (as monotherapy or in combination with other drugs)→considered to achieve LDL-C <1.8 mmol/L (<~70 mg/dL)(class IIa C) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Familial Hypercholesterolaemia FH is suspected in subjects with CVD aged <50 years (♂) or <60 years (♀), relatives with premature CVD, known FH in the family. Confirm the diagnosis with clinical criteria or with DNA analysis. Family screening is indicated when a patient with HeFH is diagnosed. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Familial Hypercholesterolaemia HeFH→high dose statin (whenever needed in combination with cholesterol absorption inhibitors and/or a bile acid sequestrant)(class I C) Treatment targets; For high risk subjects→LDL-C<2.5 mmol/L (<~100 mg/dL) For very high risk subjects→LDL-C<1.8 mmol/L (<~70 mg/dL) If targets can not be reached, max reduction of LDL-C by drug combinations in tolerated doses (class IIa C) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Heart Failure and Valvular Diseases n-3 PUFAs (1 g/day)→to be added to optimal tx in patients with HF (class IIb B) Cholesterol-lowering therapy by statins→not indicated in patients with moderate to severe HF (NYHA IIIIV)(class III A) Lipid-lowering tx→not indicated in patients with valvular disease without CAD (class III B) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Peripheral Arterial Disease PAD is a high risk condition and lipid- lowering therapy (mostly statins) is recommended (class I A) Statins→recommended to reduce the progression of carotid atherosclerosis (class I A) Statins→recommended to prevent the progression of aortic aneurysm (class I C) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. The Elderly Tx with statins→recommended for elderly patients with established CVD in the same way as for younger patients (class I B) Elderly people often have comorbidities and have altered pharmacokinetics Recommended to start lipid-lowering medication at a low dose and then titrate with caution to achieve target lipid levels which are the same as in the younger subjects (class I C) ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Women Statin tx→recommended for primary prevention of CAD in high risk women Statins→recommended for secondary prevention in women with the same indications and targets as in men Lipid-lowering drugs should not be given when pregnancy is planned, during pregnancy or during the breast-feeding period ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Novel/Important Aspects-5 Relevance of lifestyle changes not just in the reduction of total risk, but also in the specific treatment of dyslipidemias. Anguita M, et al. Rev Esp Cardiol. 2011 Dec;64(12):1090-5. Lifestyle Changes The guidelines place a great amount of emphasis on the effects of lifestyle changes on the different plasma lipids associated with the atherosclerotic process. The recommendations related to lifestyle changes are presented in detail, including which foods are more or less advisable, physical activity, and smoking cessation. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Lifestyle Changes Consumption of fruits, vegetables, legumes, nuts, wholegrain cereals and bread, fish (especially oily). Saturated fat should be replaced with those foods and with monounsaturated and polyunsaturated fats from vegetable sources. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Lifestyle Changes Energy intake should be adjusted to prevent overweight and obesity. Reduce energy intake from: total fat to <35% saturated fat to <7% trans fats to <1% dietary cholesterol to <300 mg/day The intake of beverages and foods with added sugars, particularly soft drinks, should be limited. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Lifestyle Changes Dietary supplements and functional foods: 2 g/day of phytosterols→lower TC and LDL-C by 7–10% when consumed with the main meal. Foods enriched with water-soluble fibres→recommended for LDL-C lowering (5–15 g/day). 2–3 g/day of fish oil (rich in long chain n-3 fatty acids)→reduce TG levels by 25–30%. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Lifestyle Changes Salt intake <5 g/day Alcohol consumption: <10-20 g/day for women <20-30 g/day for men Regular physical exercise for at least 30 minutes/day every day Use and exposure to tobacco products should be avoided ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2011 Jul;32(14):1769-818. Guidelines are Nothing without Implementation We should develop implementation strategies bearing always in mind that the aim of the guidelines is to assist the physicians in selecting the best management strategies for treating dyslipidaemia in an individual patient and having a reliable guidance in this is definitely better than having none. Reiner Z. Eur J Cardiovasc Prev Rehabil. 2011; 18(5): 724-7. THANK YOU ONDOKUZ MAYIS UNIVERSITY, SAMSUN, TURKEY