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THE POSITION OF STATINS IN THE NEW GUIDELINE. Suroto Dept of Neurology, Fac of Medicine, Sebelas Maret University. Stroke Risk Factors—Overview. Unmodifiable Risk Factors Age Male sex Race Family history of stroke/coronary heart disease Modifiable Risk Factors Smoking Diet

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THE POSITION OF STATINS IN THE NEW GUIDELINE


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    1. THE POSITION OF STATINS IN THE NEW GUIDELINE Suroto Dept of Neurology, Fac of Medicine, SebelasMaret University

    2. Stroke Risk Factors—Overview Unmodifiable Risk Factors • Age • Male sex • Race • Family history of stroke/coronary heart disease Modifiable Risk Factors • Smoking • Diet • Sedentary lifestyle • Alcohol/Drug abuse • Obesity • Carotid artery disease • Atrial fibrillation • Hypertension • Diabetes • Dyslipidemia Treatment Options Carotid endarterectomy Antiplatelet therapy Anticoagulation therapy Antihypertensive therapy Antidiabetic therapy Lipid-lowering therapies Goldstein LB et al. Stroke. 2001;32:280-299.

    3. HISTORY • Akira Endo and Masao Kuroda of Tokyo, Japan commenced research into inhibitors of HMG CoA reductase in1971. • This team reasoned that certain microorganism may produce inhibitors of the enzyme to defend themselves against other organism. • The first agent isolated wasMevastatin ( ML- 236 ). • The pharmaceutical company, Merck & Co showed an interest in the Japanese research in1976,and isolated Lovastatin(mevinolin, MK803), the first commercially marketed statin. • Dr Endo was awarded the 2006 Japan Prize for his work on the development of statins.

    4. Potential mechanisms of benefit of statins Reduction in chylomicron and VLDL remnants, IDL, LDL-C HMG Co A reductase inhibitor Statins* Pleitrophic effect Lipid lowering effect • Anti-inflammatory effects • Decreased thrombosis • Restore endothelial function • Maintain SMC function Macrophages Lumen Lipid core Smooth muscle cells

    5. Potential Time Course of Statin Effects in CAD / ACS Vulnerableplaquesstabilized LDL-C lowered* Inflammationreduced Cardiaceventsreduced* Ischemicepisodesreduced Endothelialfunctionrestored Hours-Days Weeks-Months * Time course established

    6. Hypertension Statin Evidence: Expanding Benefits Acute coronary event No history of CAD Unstable CAD Stable CAD 4 month AFCAPS / TexCAPS/WOSCOPS MIRACL CARE/LIPID t = 0 4S 3 month 6 month HPS ASCOT-LLA Primary prevention Secondary prevention

    7. TNT-PBO TNT-Rx Statinin primary and secondary prevention trials ; The lower the better 4S-PBO Secondary prevention Primary prevention 25 20 LIPID-PBO 4S-Rx With CHD event (%) CARE-PBO 15 HPS-PBO CARE-Rx LIPID-Rx 10 WOS-PBO HPS-Rx WOS-Rx 5 AFCAPS-Rx AFCAPS-PBO 0 50 70 90 110 130 150 170 190 210 PBO = Placebo Rx = Treated LDL-C (mg/dL)

    8. NCEP - ATP Guidelines

    9. The revised ATP-III was based on the review of five statin trials conducted since the release of ATP-III • LDL-C <70 mg/dL considered in extremely high risk patient. • LDL-C lowering drug indicated in addition to TLC if LDL-C > 100 mg/dL • The intensity of LDL-lowering drug tx in high – moderately high risk patients must be sufficient to achieve at least 30-40% reduction in LDL levels Revised ATP-III 2004 • se emphasis on 1st prevention • inclusion of high risk groups for 2nd prevention • new risk levels for major lipid measures ( LDL-C <100 mg/dL optimal level for all adults; HDL-C > 40 mg/dL and TG < 150 mg/dL ) • Important secondary target were non-HDL-C in patient with TG > 200 mg/dL and metabolic syndrome • New category “CHD risk equivalent” in diabetes and patients with > 20% CHD 10 year risk equivalent. • Global risk score based on Framingham Heart Study used for calculation of 10 year risk ATP - III 2001 • LDL-C target < 100 mg/dL • Focus on 2nd Prevention • Introduction of HDL-C as CHD risk ( <35 mg/dL ) • TG level<200 mg/dL was normal ATP - II 1993 • LDL-C target < 130 mg/dL • Focus on 1st Prevention ATP - I TLC : Therapeutic Lifestyle Changes 1988

    10. Comparison of Major Features of ATP II and ATP III ATP II ATP III < 100 mg/dL <70mg/dL in very high risk patients ( revised ) • LDL-C target for CHD or CHD Risk Equivalent : £ 100 mg/dL • LDL-C level in very high cholesterol : ³ 220 mg/dL ³ 190 mg/dL < 35 mg/dL < 40 mg/dL • Categorically low HDL-C : • Triglycerides : < 200 mg/dL < 150 mg/dL • Diabetes : Risk Factor CHD Equivalent • Completion of Framingham Risk Assessment : No Yes Total-C, HDL-C, LDL-C, and TG Total-C and HDL-C • Recommended lipid • profile : Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA. 1993;269:3015. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA. 2001;285:2486.

    11. ESC/EAS Guidelines

    12. ESC/EAS Guidelines for the management of dyslipidaemias Intervention strategies as a function of total CV risk and LDL-C level Lifestyle intervention, consider drug if uncontrlled <1 No lipid intervention No lipid intervention Lifestyle intervention Lifestyle intervention Lifestyle intervention, consider drug if uncontrlled Lifestyle intervention, consider drug if uncontrlled Lifestyle intervention, consider drug if uncontrlled >1 to <5 Lifestyle intervention Lifestyle intervention Lifestyle intervention, consider drug Lifestyle intervention, consider drug Lifestyle intervention, and immediate drug intervention Lifestyle intervention, and immediate drug intervention Lifestyle intervention, and immediate drug intervention >5 to <10, or high risk Lifestyle intervention, and immediate drug intervention Lifestyle intervention, and immediate drug intervention Lifestyle intervention, and immediate drug intervention Lifestyle intervention, consider drug Lifestyle intervention, and immediate drug intervention >10 or very high risk ESC/EAS : European Society of Cardiology /European Atherosclerosis Society European Heart Journal (2011) 32, 1769–1818

    13. + SCORE 5 15% and over 1 10-14% Age 5-9% 2 3-4% 2% 1% < 1% 10-year risk of fatal CVD in populations at high CVD risk 3 Total cardiovascular risk estimation 4 European Heart Journal (2011) 32, 1769–1818

    14. Risk will be higher than calculated in patients with additional conditions such as: • Diabetes • Evidence of subclinical atherosclerosis (CalciumScore, Carotid Screening) • Familial premature atherosclerotic disease • Chronic Kidney Disease • Increased Lp (a), AboB/ApoB1 ratio, low HDL-C, high TC

    15. •In patients at very high CV risk : established CVD, type 2 diabetes or type 1 diabetes with target organ damage, moderate to severe CKD or a SCORE level ≥10 % the LDL-C goal is <1.8 mmol/L(<~70 mg/ dL) and/or a ≥ 50 % LDL-C reduction when target level cannot be reached. •In patients at high CV risk : markedly elevated single risk factors, a SCORE level ≥5 - <10% the LDL-Cgoal <2.5 mmol/L (<~100 mg/dL). • In patients at moderate risk : SCORE level >1 to ≤5% the LDL-C goal <3.0 mmol/L (<~115 mg/dL). If drug treatment is indicated to decrease LDL-C, a statin is recommended, up to the highest tolerable dose, to reach the target level.

    16. 2013 ACC/AHA Guideline

    17. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults November 12, 2013 • First new guidelines since ATP III guideline update in 2004 • The most important statements or changes presented in these guidelines • No longer have therapeutic targets • New risk calculator • Use medications proven to reduce risk, ie statins • Avoid medications or supplements that may lower the cholesterol number, but have no data to decrease CV risk Circulation,published online November 12, 2013

    18. Overview of the Expert Panel’s guideline

    19. What has changed compared to ATP-III guideline? • Initiate either moderate-intensity or high-intensity statin therapy for patients who fall into the four categories • Unlike ATP-III, Do not titrate to a specific LDL cholesterol target • Measure lipids during follow-ups to assess adherence to treatment, not to achieve a specific LDL target

    20. Four Major Statin Benefit Groups • Individuals with clinical ASCVD • Individuals with LDL >190 • Individuals with Diabetes, 40-75 yowith LDL 70-189 and without clinical ASCVD • Individuals without clinical ASCVD or Diabetes, with LDL 70-189 and estimated 10-year ASCVD risk >7.5% ASCVD : AtheroSclerotic CardioVascular Disease

    21. Age < 75y High-intensity statin (Moderate-intensity if not candidate for high intensity Statin) Yes Clinical ASCVD Adults age > 21y and A candidate for Statin Tx Yes Age > 75y or if not candidate for high intensity Statin Moderate-intensity statin Yes No No Cardiovascular risk calculator High-intensity statin (Moderate-intensity if not candidate for high intensity Statin) LDL-C > 190 mg/dL Yes No Moderate-intensity statin Yes Moderate-intensity statin • Diabetes • Age 40-75 y Estimated 10-y ASCVD risk >7.5% High intensity statin Yes No Cardiovascular risk calculator Estimate 10-y ASCVD risk With Pooled Cohort Equation • > 7.5% estimated 10-y ASCVD risk • Age 40-75 y Moderate-to- high intensity statin Yes

    22. Intensity of Statin Therapy High-Moderate-and Low-Intensity Statin Therapy (Used in the RCTs reviewed by the Expert Panel) RCT : Randomized Control Trials Circulation,published online November 12, 2013

    23. Risk Assessment : Sex M or F Age Years ( 40-79 ) Race AA ( Afro american ) or WH ( White or others ) Total Cholesterol mg/dL ( 130 - 320 ) HDL-Cholesterol mg/dL ( 20 – 100 ) Systolic blood pressure mmHg ( 90 – 200 ) Treatment for High blood pressure Y ( Yes ) or N ( No ) Diabetes Y ( Yes ) or N ( No ) Smoker Y ( Yes ) or N ( No ) http://my.americanheart.org/cvriskcalculator

    24. This calculator only provides 10-year risk estimates for individuals 40-79 years of age Risk Assessment : Your 10 year ASCVD Risk (%) 10 year ASCVD Risk (%) for someone with optimal risk factor ( Col E ) Column Chart Your lifetime ASCVD Risk (%) Lifetime ASCVD Risk (%) for someone with optimal risk factor ( Col E )

    25. STATIN Safety recommendations (1) • Select the appropriate dose • If high or moderate intensity statin not tolerated, use the maximum tolerated dose instead • Conditions that could predispose patients to statin side effect: • Impaired renal or hepatic function • History of previous statin intolerance or muscle disorder • Age >75 • Unexplained ALT elevation > 3x ULN • History of hemorrhagic stroke • Asian ancestry

    26. STATIN Safety recommendations (2) • Check baseline ALT prior initiating the statin (Grade B) • Check LFTs if patient develops Symptoms of hepatic dysfunction (Grade E) • If 2 consecutive LDL <40, Consider decreasing the statin dose (Grade C, weak recommendation) • It may be harmful to initiate simvastatin 80mg, or increase the dose of simvastatin to 80mg (Grade B)

    27. Case 1 50 year old white female • Total cholesterol 180 • HDL: 50 • SBP: 130 • taking anti-hypertension meds • + diabetic • + smoker Calculated 10 yr ASCVD: 9.1%

    28. 9.1 Your 10 year ASCVD Risk (%) 0.8 10 year ASCVD Risk (%) for someone with optimal risk factor ( Col E ) Your lifetime ASCVD Risk (%) 50.0 Lifetime ASCVD Risk (%) for someone with optimal risk factor ( Col E ) 8.0 Lifetime ASCVD Risk (%) for someone with optimal risk factor ( Col E ) 10 year ASCVD Risk (%) for someone with optimal risk factor ( Col E ) Your 10 year ASCVD Risk (%) Your Lifetime ASCVD Risk (%)

    29. Age < 75y High-intensity statin (Moderate-intensity if not candidate for high intensity Statin) Yes Clinical ASCVD Adults age > 21y and A candidate for Statin Tx Yes Age > 75y or if not candidate for high intensity Statin Moderate-intensity statin Yes No High-intensity statin (Moderate-intensity if not candidate for high intensity Statin) LDL-C > 190 mg/dL Yes No Moderate-intensity statin Yes Moderate-intensity statin • Diabetes • Age 40-75 y Estimated 10-y ASCVD risk >7.5% High-intensity statin Yes No Cardiovascular risk calculator Estimate 10-y ASCVD risk With Pooled Cohort Equation • > 7.5% estimated 10-y ASCVD risk • Age 40-75 y Moderate-to- high intensity statin Yes

    30. Case 2 48 year white female • Total cholesterol 180 • HDL: 55 • SBP: 130 • Not taking anti-hypertension meds • + diabetic • Non-smoker Calculated 10 yr risk ASCVD : 1.8%

    31. Your 10 year ASCVD Risk (%) 1.8 10 year ASCVD Risk (%) for someone with optimal risk factor ( Col E ) 0.7 Your lifetime ASCVD Risk (%) 39.0 Lifetime ASCVD Risk (%) for someone with optimal risk factor ( Col E ) 8.0 Your 10 year ASCVD Risk (%) 10 year ASCVD Risk (%) for someone with optimal risk factor ( Col E ) Your Lifetime ASCVD Risk (%) Lifetime ASCVD Risk (%) for someone with optimal risk factor ( Col E )

    32. Age < 75y High-intensity statin (Moderate-intensity if not candidate for high intensity Statin) Yes Clinical ASCVD Adults age > 21y and A candidate for Statin Tx Yes Age > 75y or if not candidate for high intensity Statin Moderate-intensity statin Yes No High-intensity statin (Moderate-intensity if not candidate for high intensity Statin) LDL-C > 190 mg/dL Yes No Moderate-intensity statin Yes Moderate-intensity statin • Diabetes • Age 40-75 y Estimated 10-y ASCVD risk >7.5% High intensity statin Yes No Cardiovascular risk calculator Estimate 10-y ASCVD risk With Pooled Cohort Equation • > 7.5% estimated 10-y ASCVD risk • Age 40-75 y Moderate-to- high intensity statin Yes

    33. Case 3 22 year white male • LDL- cholesterol 195 • SBP: 120 • Not taking anti-hypertension meds • Non-diabetic • Non-smoker

    34. Age < 75y High-intensity statin (Moderate-intensity if not candidate for high intensity Statin) Yes Clinical ASCVD Adults age > 21y and A candidate for Statin Tx Yes Age > 75y or if not candidate for high intensity Statin Moderate-intensity statin Yes No No Cardiovascular risk calculator High-intensity statin (Moderate-intensity if not candidate for high intensity Statin) LDL-C > 190 mg/dL Yes No Moderate-intensity statin Yes Moderate-intensity statin • Diabetes • Age 40-75 y Estimated 10-y ASCVD risk >7.5% High intensity statin Yes No Estimate 10-y ASCVD risk With Pooled Cohort Equation • > 7.5% estimated 10-y ASCVD risk • Age 40-75 y Moderate-to- high intensity statin Yes

    35. Summary • The statins (or HMG-CoA reductase inhibitors) form a class of Hypolipidemic drugs used to lower cholesterol levels in people with or at risk of Cardiovascular disease. • Based on clinical trials (RCT), the National Cholesterol Education Program / Adult Treatment Panel (NCEP-ATP) had developed guidelines, focus on aggressively lowering LDL-cholesterol. • The statins continue to play an important role in both the primary and secondary prevention of ASCVD. • End of 2013 the ACC and AHA , collaborate with the National Heart, Lung, and Blood Institute (NHLBI) develop new clinical practice guidelines for assessment of CV risk, lifestyle modifications to reduce CV risk, and management of blood cholesterol. • This guideline focuses on treatments to reduce ASCVD events. ASCVD : AtheroSclerotic CardioVascular Disease RCT : Randomized Control Trial