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NCEP ATP IV GUIDELINES: 2013 UPDATE Kerry Haney, PharmD, BCACP, CPP UM Skaggs School of Pharmacy 1/12/13.

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Presentation on theme: "NCEP ATP IV GUIDELINES: 2013 UPDATE Kerry Haney, PharmD, BCACP, CPP UM Skaggs School of Pharmacy 1/12/13."— Presentation transcript:

1 NCEP ATP IV GUIDELINES: 2013 UPDATE Kerry Haney, PharmD, BCACP, CPP UM Skaggs School of Pharmacy 1/12/13

2 Learning Objectives 1. List three anticipated changes to the ATP IV guidelines 2. Compare and contrast two validated risk assessment tools used to stratify risk of developing cardiovascular disease and individualize LDL-c goals 3. Describe the primary treatment targets from the ATP III guidelines and potential changes for ATP IV

3 National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) Guidelines U.S. guidelines for the detection, evaluation, and treatment of hyperlipidemia in adults Developed by an expert panel for the National Heart, Lung, and Blood Institute (NHLBI) Division of National Institutes of Health (NIH) Long history of developing clinical practice guidelines First JNC report published 1976 ATP release history: ATP I First released in 1988 ATP II 1993 ATP III 2001

4 For more information or to check status:

5 Potential Changes for ATP IV Current guidelines ATP III Focus on LDL-c Greatest intensity of treatment for patients at highest risk Other dyslipidemia management guidelines Changes in LDL-c targets for those at highest risk Some modifications of risk factors Direction from expert panel for ATP IV Critical questions Scientific evidence from clinical trials

6 U.S. Guidelines for Management of Dyslipidemias 2001NCEP ATP III guidelines 2004NCEP ATP III implications 2008ADA/ACCF Consensus Statement on Lipoprotein Management in Patients with Cardiometabolic Risk 2011AHA/ACC guidelines for secondary prevention 2012 AACE Guidelines for the Management of Dyslipidemia and Prevention of Atherosclerosis 2013ADA Standards of Medical Care in DM AACE = American Association of Clinical Endocrinologists, ACC = American College of Cardiology, ACCF = American College of Cardiology Foundation, ADA = American Diabetes Association, AHA= American Heart Association

7 Critical Questions for ATP IV What evidence supports LDL-c goals for secondary prevention? What evidence supports LDL-c goals for primary prevention? What is the impact of the major cholesterol drugs on efficacy/safety in the populations?

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9 Overview of Potential Changes for ATP IV Modification of CVD Risk Estimation Adjustment of major risk factors and CHD risk equivalents Alternative risk assessment tool to Framingham Risk Score (FRS) Changes in Treatment Targets Changes in LDL-c goals More aggressive treatments in those at elevated risk of CHD Changes in target emphasis Recommended Pharmacologic Treatment Continued use of statins at optimal dosing Highlight lack of CV outcome evidence for adjunctive therapies

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11 ATP III Classification of Cholesterol Concentrations LipoproteinConcentration (mg/dL)Interpretation TC< Desirable Borderline high High LDL-c< Optimal Near/above optimal Borderline high High Very high HDL-c<40 60 Low High TG< Normal Borderline high High Very high

12 ATP III Treatment Targets Exception: TG lowering is an immediate target if 500 mg/dL Primary Target: LDL-c Secondary Target: Non-HDL-c (Once LDL goal met and if TG 200)

13 NCEP ATP III: Determining LDL-c Goals Yes No Presence of ASVD, DM High-Risk: <100mg/dL, optional <70mg/dL 2 major CV risk factors* 10-year CHD risk: FRS >20%10-20%<10% High-Risk: <100mg/dL Mod-high Risk: <130mg/dL, optional <100mg/dL Moderate risk <130mg/dL Lower risk <160mg/dL

14 ATP III 2004 Implications Very high risk definition: Presence of CVD plus: Multiple major risk factors (DM) Severe and poorly controlled risk factors (smoking) Metabolic syndrome ACS Optional goal of LDL-c < 70

15 Potential Change for ATP IV CHD Risk Equivalents Chronic kidney disease (CKD) Potentially added as a CHD risk equivalent Increased risk of CHD and premature CHD Evidence suggests patients with CKD have expected 10-yr risk CHD > 20% Guidelines National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) Group 2003 AHA supported recommendation 2003

16 NCEP ATP III: Determining LDL-c Goals Yes No Presence of ASVD, DM High-Risk: <100mg/dL, optional <70mg/Dl 2 major CV risk factors* 10-year CHD risk: FRS >20%10-20%<10% High-Risk: <100mg/dL Mod-high Risk: <130mg/dL, optional <100mg/dL Moderate risk <130mg/dL Lower risk <160mg/dL

17 ATP III Risk Stratification for LDL-c Goal Determine presence of other major risk factors Age Men45 Women 55 Family history of premature CHD First degree relative with heart disease in males before 55 or women before 65 Hypertension 140/90 or on antihypertensive medications Cigarette smoking Low HDL 60) If 2 or more risk points are present, then calculate FRS

18 NCEP ATP III: Determining LDL-c Goals Yes No Presence of ASVD, DM High-Risk: <100mg/dL, optional <70mg/Dl 2 major CV risk factors* 10-year CHD risk: FRS >20%10-20%<10% High-Risk: <100mg/dL Mod-high Risk: <130mg/dL, optional <100mg/dL Moderate risk <130mg/dL Lower risk <160mg/dL

19 Framingham Risk Assessment Tool Background Derived from the Framingham Heart Study Validated method to predict 10-year risk of hard coronary heart disease (nonfatal MI or coronary death) Used in those without ASVD or risk equivalents (DM) Score Low 20% Limitations Predicts risk best ages Less precise in those with diabetes, pre-diabetes, severe HTN, LVH, younger men and women, and some racial groups – Japanese-Americans, Hispanic men, and Native American women. Limited to estimation of 10-year risk Available

20 Framingham Risk Assessment Tool

21 Alternative Risk Assessment Tools Reynolds Risk Assessment (RRS) Tool has been developed to improve 10-year risk estimation FRS may underestimate risk in the young and in women who are classified as low risk Utilizes 7 risk factors: age, SBP, TC, HDL-c, smoking hs-CRP 3 mg/L (high risk) parental history of premature MI An optional assessment tool in the Canadian Cardiovascular Society guidelines 2009 and 2012 AACE Dyslipidemia Guidelines

22 NCEP ATP III: Determining LDL-c Goals Yes No Presence of ASVD, DM High-Risk: <100mg/dL, optional <70mg/Dl 2 major CV risk factors* 10-year CHD risk: FRS >20%10-20%<10% High-Risk: <100mg/dL Mod-high Risk: <130mg/dL, optional <100mg/dL Moderate risk <130mg/dL Lower risk <160mg/dL

23 Anticipated Changes to LDL-c Goals Optional goals will become new treatment goals LDLc goal < 70 for very high risk High risk and moderate risk less clear Several clinical trials have shown consistent reduction in CHD events (patients with CHD or ACS) when achieving LDL-c of 60-80mg/dL compared to LDL-c levels of 100mg/dL PROVEIT-TIMI22, A-to-Z, TNT, IDEAL One study has also shown coronary atheroma regression when LDL-c levels are lowered below 80mg/dL (average 60.8mg/dL) with high potency statins Asteriod Two studies have shown continuous risk reduction in patients with moderate risk taking statins ASCOT, JUPITER

24 ADA/ACCF Consensus Statement Lipoprotein Management in Patients with Cardiometabolic Risk LDLc (mg/dL) Non-HDLc (mg/dL) Apo B (mg/dL) Very High Risk Established CVD DM and 1 major CVD risk factors* <70<100<80 High Risk No CVD and 2 major CVD risk factors* DM and no major CVD risk factors* <100<130<90 Brunzell JD, et al. Diabetes Care 2008; 31: *Risk factors: dyslipidemia, smoking, HTN, family history of premature CAD

25 AACE LDLc Treatment Goals Risk CategoryPatient PopulationLDLc (mg/dL) Very High RiskEstablished or recent hospitalization for coronary, carotid or peripheral vascular disease DM with additional risk factors < 70 High Risk 2 major risk factors and FRS > 20% CHD risk equivalent < 100 Moderately High Risk 2 major risk factors and FRS 10-20%<130 Moderate Risk 2 major risk factors and FRS < 10%< 130 Low Risk risk factor< 160 CHD risk equivalent = DM, PAD, AAA, CAD Endocr Pract. 2012; 18 (Suppl 1)

26 Treatment Strategies Statins Recommended first line: Most robust data for efficacy in reducing CHD events LDL lowering with statin therapy correlates with 30-35% CVD relative risk reduction Lowers LDL 21-63% Pleiotropic effects Improves endothelial function Inhibits platelet aggregation Decreases LDL oxidation Reduces vascular inflammation Stabilizes atherosclerotic plaques CV event reduction has been disappointing when adding on other lipid lowering therapies Enhance, SEAS – statin plus ezetimibe AIM-HIGH – statin plus niacin ACCORD – fenofibrate plus simvastatin (in DM)

27 Questions


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