Sanger Heart & Vascular Institute Symposium 2015 Cardiovascular Update For Primary Care Physicians William E. Downey, MD FACC FSCAI Medical Director, Interventional Cardiology Sanger Heart & Vascular Institute New Lipid Management Guidelines: Lipids Meet Science
Disclosures None 1/26/2015 2
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Multiple Guidelines 1/26/2015 5
2013 ACC/AHA Guideline Development: What data did they use? Randomized controlled trials with clinical endpoints published before 2012 All of these compared relatively fixed doses of statins either to placebo or to other statins. No RCT data on a treat-to-target approach. 1/26/2015 6
Why focus on RCTs with clinical endpoints? Examples of discordant finding from observational and randomized studies: Niacin and cardiovascular disease Hormone replacement therapy and cardiovascular disease Folate and cardiovascular disease Vitamin E and cardiovascular disease β-carotene and cardiovascular disease β-carotene and cancer Vitamin E and lung cancer Bisphosphonates and breast cancer prevention Statins for prevention of COPD exacerbations Inhaled glucocorticoids for reduction in COPD mortality 1/26/2015 7
Who Benefits from LDL reduction? Established clinical atherosclerosis (secondary prevention). Primary prevention in people with: LDL 190. Diabetes + age 40-75 + LDL 70. Age 40-75 with estimated 10 year ASCVD risk 7.5%. Age 40-75 with estimated 10 year ASCVD risk 7.5%. Consider: LDL 160 Family history of premature atherosclerosis hscrp 2 mg/dl Coronary calcium score 300 or 75 th %ile ABI < 0.9 1/26/2015 8
Specific subgroups with insufficient data for recommendation CHF NYHA class II-IV Patients on hemodialysis 1/26/2015 9
Statin Risks Increased incidence of diabetes Moderate intensity statin increases risk by 0.1/100 patient years Moderate intensity statin increases risk by 0.3/100 patient years 1/26/2015 10
Myopathy Statin Risks 0.01/100 patient years JUPITER trial (rosuvastatin 20mg vs placebo) Muscle symptoms in 16.0% vs 15.4% Hemorrhagic stroke 0.01/100 patient years Liver toxicity Rare. Check baseline ALT but no further monitoring unless symptoms suggestive of liver disease develop. 1/26/2015 11
Intensity of statin therapy High intensity statin Moderate intensity statin Lowers LDL 50% Lowers LDL 30-50% Atorvastatin 80 (40) mg daily Rosuvastatin 20 (40) mg daily Atorvastatin 10-20mg daily Rosuvastatin 5-10mg daily Simvastatin 20-40mg daily Lovastatin 40mg daily Fluvastatin XL 80 mg daily Fluvastatin 40mg bid Pitavastatin 2-4mg daily Source: Consumer Reports, High Cholesterol and Heart Disease, 2014 1/26/2015 12
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Simple 2013 ACC/AHA Lipid Guidelines Practical Data driven Patient Centric 1/26/2015 15
Sanger Heart & Vascular Institute Symposium 2015 Cardiovascular Update For Primary Care Physicians Cheryl Russo, MD, FACC Adult Cardiology ACC/AHA Lipid Guidelines for Primary Prevention Unvarnished Truth
Disclosures None 1/26/2015 17
Discussion Strategies 1. Focus on what looks good. 2. Bash the subject. 3. Redirect attention to a better alternative. 4. Speak unvarnished truth. 1/26/2015 18
Areas of Concern 1. Risk Assessment 2. Randomized Controlled Trials 3. Exclusion of Groups 4. No Targets 1/26/2015 19
Risk Assessment Equations Gender/Race Recommend Age 40 ASCVD and Stroke, not CHF Generation Population changes: Smoking, Trans Fat, Medications MESA Threshold Statin Treatment Family History Stroke 1/26/2015 20
Decreased Trans Fat Decreased Smoking Population Trends Decreased Trans Fat Increase in Preventive Medicine Increase in Preventive Medicine 1/26/2015 21 Cardiovascular Update For Primary Care Physicians 2015
Framingham, Mass 1950 ATP-III Modified FRS 1/26/2015 22 Cardiovascular Update For Primary Care Physicians 2015
American Diversity Equations for non-hispanic white, black and women Pooled data Framingham and offspring, ARIC, CHS, CARDIA 1/26/2015 23 Cardiovascular Update For Primary Care Physicians 2015
MESA 6 Communities Men and Women 45-84 yr old 1/3 white, ¼ AA, ¼ Hispanic, 1/10 Asian Prevalence and Progression of Subclinical CV disease Improvement Risk Discrimination Event Rate 0 RF/CAC >300 3.5X 3 RF/CAC 0 1/26/2015 24
Calcium Score Cheap 1mSv Predicts Risk Individual 1/26/2015 25
Statin Treatment Thresholds High Risk ATP-III >20% 10 yr risk 10 yr risk of 7.5% Intermediate Risk ATP-III 10 yr risk 10-20% 10 yr risk 5-7.5% Narrow, minimizes gains from imaging 1/26/2015 26
We all ask about it Family History Considered, did not improve models Did not distinguish premature CVD Predictor of subsequent events Canadian Cardiovascular Society Guidelines doubles risk 1/26/2015 27
Risk Assessment Refine with additional testing Family history CRP (>2) Coronary Artery Calcium (>300, >75%ile) ABI (<0.9) No evidence downgrade 1/26/2015 28
Stroke Risk Estimator more sensitive to age Leads to overtreatment Example: 65 yr old white man, TC 150, HDL 50, SBP 120 9.4% RCT (AFCAPS) no benefit 40mg lovastatin 40% Stroke are of large vessel atherosclerotic source Embolic Hemorrhagic 1/26/2015 29
Randomized Controlled Trials Incorporate available data and draw conclusions Perfect RCT? Lifestyle interventions elsewhere Areas not adequately explored by RCT Combined drug therapy Patient groups 1/26/2015 30
Metabolic Syndrome Exclusion of Groups Elderly Inflammatory Disease Pre-eclampsia 2011 AHA Women s Guidelines major risk factors 1/26/2015 31
Elderly No age cut off for intervention Increase risk threshold? SAGE Study Assessing Goals in the Elderly PROSPER Prospective Evaluation of Pravastatin in the Elderly 1/26/2015 32
No Target Goals How do we evaluate risk reduction? What is the patient s goal? Performance Metrics based LDL targets 1/26/2015 33
Areas of Concern 1. Risk Assessment 2. Randomized Controlled Trials 3. Exclusion of Groups 4. No Targets 1/26/2015 34
Current under-treatment of hypercholesterolemia Maddox et al. JACC 2014; 64: 2183 1/26/2015 35
How can we improve on this? Patient activation Better education of risks and benefits Risk tools with visual explanations Education tools Financial education Clinical support Pathways Non-physician support Population management Tableau 1/26/2015 36
Mayo Statin Decision Aid 1/26/2015 37
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Statin Costs High intensity statin Moderate intensity statin Lowers LDL 50% Lowers LDL 30-50% Atorvastatin 80 (40) mg daily ($18 Costco) Rosuvastatin 20 (40) mg daily ($207) Atorvastatin 10-20mg daily ($17 Costco) Rosuvastatin 5-10mg daily ($201) Simvastatin 20-40mg daily ($4 Kmart, Walgreen, Costco) Lovastatin 40mg daily ($4 Target, Kmart, Walmart, Walgreen) Fluvastatin XL 80 mg daily ($217) Fluvastatin 40mg bid ($235) Pitavastatin 2-4mg daily ($180) NB: Pill splitting halves cost for everything but top doses Source: Consumer Reports, High Cholesterol and Heart Disease, 2014 1/26/2015 40
Medication-related financial advice I can t afford my statin! $18 per month at Costco. We need to know that in real time and prescribe accordingly. 1/26/2015 41
Tableau Pt name 1/26/2015 42
Tableau 1/26/2015 43
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Tableau Provider Names 1/26/2015 45
Lipid Management in the Future Outcome-driven Cost-conscious Population-based Patient Centric 1/26/2015 46