Transcript NCEP ATP IV Guidelines - Montana Pharmacy Association
NCEP ATP IV GUIDELINES:
2013 UPDATE
Kerry Haney, PharmD, BCACP, CPP UM Skaggs School of Pharmacy 1/12/13
Learning Objectives
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List three anticipated changes to the ATP IV guidelines Compare and contrast two validated risk assessment tools used to stratify risk of developing cardiovascular disease and individualize LDL-c goals Describe the primary treatment targets from the ATP III guidelines and potential changes for ATP IV
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
For more information or to check status: http://www.nhlbi.nih.gov/guidelines/indevelop.htm
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
U.S. Guidelines for Management of Dyslipidemias
2001 2004 2008 2011 2012 2013 NCEP ATP III guidelines NCEP ATP III implications ADA/ACCF Consensus Statement on Lipoprotein Management in Patients with Cardiometabolic Risk AHA/ACC guidelines for secondary prevention AACE Guidelines for the Management of Dyslipidemia and Prevention of Atherosclerosis ADA 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
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?
Overview of Potential Changes for ATP IV
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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
Lipoprotein
TC LDL-c HDL-c TG
ATP III Classification of Cholesterol Concentrations
Concentration (mg/dL)
< 200 200-239 ≥240 <100 100-129 130-159 160-189 ≥190 <40 ≥60 <150 150-199 200-499 ≥500
Interpretation
Desirable Borderline high High Optimal Near/above optimal Borderline high High Very high Low High Normal Borderline high High Very high
ATP III Treatment Targets
Primary Target: LDL-c Secondary Target: Non-HDL-c (Once LDL goal met and if TG ≥200) Exception: TG lowering is an immediate target if ≥ 500 mg/dL
NCEP ATP III: Determining LDL-c Goals
Presence of ASVD, DM ≥2 major CV risk factors* Yes No Yes No 10-year CHD risk: FRS High-Risk: <100mg/dL, optional <70mg/dL >20% 10-20% <10% High-Risk
:
<100mg/dL Mod-high Risk: <130mg/dL, optional <100mg/dL Moderate risk <130mg/dL Lower risk <160mg/dL
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
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
NCEP ATP III: Determining LDL-c Goals
Presence of ASVD, DM Yes No ≥2 major CV risk factors* Yes No 10-year CHD risk: FRS High-Risk: <100mg/dL, optional <70mg/Dl >20% 10-20% <10% High-Risk
:
<100mg/dL Mod-high Risk: <130mg/dL, optional <100mg/dL Moderate risk <130mg/dL Lower risk <160mg/dL
ATP III Risk Stratification for LDL-c Goal
• Determine presence of other major risk factors Age M en≥45 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 < 40mg/dL* (negative risk factor if HDL > 60)
If 2 or more risk points are present, then calculate FRS
NCEP ATP III: Determining LDL-c Goals
Presence of ASVD, DM Yes No ≥2 major CV risk factors* Yes No 10-year CHD risk: FRS High-Risk: <100mg/dL, optional <70mg/Dl >20% 10-20% <10% High-Risk
:
<100mg/dL Mod-high Risk: <130mg/dL, optional <100mg/dL Moderate risk <130mg/dL Lower risk <160mg/dL
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 <10%, Moderate 10-20%, High >20% Limitations • Predicts risk best • ages 30-65 • 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 • http://www.nhlbi.nih.gov/guidelines/cholesterol/atglance.pdf
• http://hp2010.nhlbihin.net/atpiii/calculator.asp
Framingham Risk Assessment Tool
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 • <1 mg/L low, 1-3 mg/L (intermediate), >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 • www.reynoldsriskscore.org
NCEP ATP III: Determining LDL-c Goals
Presence of ASVD, DM Yes No ≥2 major CV risk factors* Yes No 10-year CHD risk: FRS High-Risk: <100mg/dL, optional <70mg/Dl >20% 10-20% <10% High-Risk
:
<100mg/dL Mod-high Risk: <130mg/dL, optional <100mg/dL Moderate risk <130mg/dL Lower risk <160mg/dL
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
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 *Risk factors: dyslipidemia, smoking, HTN, family history of premature CAD Brunzell JD, et al. Diabetes Care 2008; 31:811-22 .
AACE LDLc Treatment Goals
Risk Category
Very High Risk
Patient Population
Established or recent hospitalization for coronary, carotid or peripheral vascular disease DM with ≥ additional risk factors
LDLc (mg/dL)
< 70 High Risk ≥ 2 major risk factors and FRS > 20% CHD risk equivalent ≥ 2 major risk factors and FRS 10-20% < 100 Moderately High Risk <130 Moderate Risk ≥ 2 major risk factors and FRS < 10% Low Risk CHD risk equivalent = DM, PAD, AAA, CAD ≤ risk factor Endocr Pract. 2012; 18 (Suppl 1) < 130 < 160
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)