Objectives. Background. Background. Estimating ASCVD Risk. ASCVD Major Risk Factors 2/20/2018

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1 Objectives Discuss risk stratification and non-pharmacologic means of reducing primary cardiovascular risk Compare and contrast pharmacologic agents for the prevention of cardiovascular disease Kevin T. Schleich, PharmD, BCACP Clinical Pharmacy Specialist, Department of Family Medicine University of Iowa Hospitals and Clinics Background Cardiovascular disease is the leading cause of death in the United States Atherosclerotic cardiovascular disease (ASCVD) afflicts ~33% of Americans as of 2017 Estimated it will affect up to 50% of Americans by 2030 ASCVD Acute coronary syndromes, history of myocardial infarction (MI), stable/unstable angina, coronary/arterial revascularization, stroke, transient ischemic attack (TIA), peripheral artery disease (of presumed atherosclerotic origin) Background Primary prevention Strategies utilized to prevent the initial occurrence of ASCVD Relative paucity of evidence to support strong recommendations for pharmacology Secondary prevention Strategies utilized to prevent subsequent ASCVD events More clear recommendations for pharmacologic therapy in patients with established ASCVD Circulation Mar 7;135(10):e146-e603 J Am Coll Cardiol. 2014;63(25): _heart_cartoon ASCVD Major Risk Factors Risk Factor > 45 years Age > 55 years < 55 years Family History* < 65 years < 40 mg/dl Low HDL < 50 mg/dl Current cigarette smoking Hypertension ( > 140/ > 90 mmhg, or treated) Diabetes *Family history of cardiovascular disease in first degree relatives Estimating ASCVD Risk Framingham Risk Calculator (2001) First risk assessment tool endorsed by National Cholesterol Education Panel (NCEP) Adult Treatment Panel (ATP-III) Tried to predict 10-year risk of MI/death Predominantly white population, therefore limited validity for a portion U.S. population Reynolds Risk Score (2008) Utilized framework of Framingham risk calculator, but added family history and high-sensitivity C-reactive protein (hs-crp) More accurately predicted CV risk in women Predicts 10-, 20- and 30-year risk of CV events J Am Coll Cardiol. 2014;63(25):

2 Estimating ASCVD Risk Further Risk Evaluation Pooled Cohort Equation (2013) Improved validity for U.S. population by including black patients Predicts 10-year and lifetime ASCVD risk Helps predict risk of stroke Lacks validity for other ethnicities Million Hearts Longitudinal ASCVD Risk Assessment Tool (2017) Predicts 10-year ASCVD risk Helps demonstrate the magnitude of effect of lifestyle modifications (i.e. starting aspirin, smoking cessation) _heart_measurement_cartoon Cardiovascular Risk Markers High-Sensitivity C-Reactive Protein (hs-crp) Non-specific biomarker that may indicate vascular inflammation When elevated to a specific degree, may be a reliable predictor of ASCVD risk 1-10 mg/l: possible vascular inflammation > 10 mg/l: acute illness, autoimmune disorders Can be helpful to further stratify risk in patients at perceived low-risk utilizing Pooled Cohort Equation hs-crp > 2 mg/l may warrant more aggressive prevention strategies N Engl J Med. 2008;359(21): Cardiovascular Risk Markers Coronary Artery Calcium (CAC) Score Calcification of coronary arteries is a risk factor for ASCVD Measurement of CAC can be done relatively quickly with a CT Elevated scores predict increased ASCVD risk > 300 Agatston units >75 th percentile for age, sex, race 2013 ACC/AHA guidelines suggested this was the most useful tool aside from traditional risk calculators Still not routinely recommended due to cost and radiation exposure J Am Coll Cardiol. 2014;63(25): J Am Coll Cardiol Jul 1;63(25 Pt B): Lifestyle Modifications Diet Mediterranean diet, DASH diet Fruits, vegetables, fish, nuts Exercise > 30 minutes of moderate-intensity exercise 5 days/week 25 minutes of vigorous aerobic activity 3 days/week Combination of two of the above days of resistance Tobacco Cessation Circulation. 2016;133: Med Sci Sports Exerc Jul;43(7):

3 Comorbid Disease Optimization Medication Management _medication How Smart Are We? AH is a 52 year-old male with no significant past medical history who comes to clinic for his annual physical exam. He takes no medications aside from a multivitamin and aspirin 81 mg daily. He recently heard on NBC Nightly News that aspirin is likely doing nothing for him except increasing his bleed risk. You tell him: a) He s probably right, the risk of aspirin likely exceeds the benefit for him b) I m interested to see where Lester Holt got his medical degree; keep taking the aspirin if you want to prevent a heart attack c) I probably want some more information about you before deciding what to do about the aspirin Aspirin Irreversibly inhibits platelet cyclooxygenase (COX) At low doses ( mg/day), aspirin will more selectively inhibit COX-1 and thromboxane A2 formation Inhibition of platelet aggregation Little to no effect on COX-2 mediated adverse effects Increased blood pressure, decreased renal function COX-1 inhibition increases risk of upper GI bleed Aspirin Efficacy vs Safety Aspirin Recommendation General Population < 50 y.o y.o y.o. > 70 y.o. Insufficient evidence to assess risk vs. benefit of aspirin for primary prevention Initiate low-dose aspirin for primary prevention in the following patients: ASCVD risk > 10% Low bleed risk Life expectancy > 10 years Willing to take aspirin daily for > 10 years *Individualized choice for the following patients: ASCVD risk > 10% Low bleed risk Life expectancy > 10 years Willing to take aspirin daily for >10 years* (Grade C) Insufficient evidence to assess risk vs. benefit of aspirin for primary prevention * patients who place a higher value on the potential benefits than the potential harms may choose to initiate low-dose aspirin.* Thrombosis Journal (2015) 13:38 3

4 Diabetes and ASCVD Adults with diabetes are 2-3 times more likely to develop ASCVD compared to those without diabetes Adults with diabetes are 2-4 times more likely to die from ASCVD than those without diabetes Deaths Among Patients With Diabetes (age > 65 ) 68% Heart Disease Other _heartanddiabetes_cartoon Aspirin Recommendation Patients With Diabetes Mellitus (DM) Aspirin ( mg/day) should be considered in patients > 50 y.o. with type 1 and type 2 DM at increased risk of ASCVD (> 1 risk factor) Family history of premature ASCVD Hypertension Dyslipidemia Current smoker Albuminuria (> 30 mcg/mg) Aspirin should not be recommended for patients with DM < 50 y.o. with no other major ASCVD risk factors Clinical judgement must be exercised when recommending aspirin for patients with DM < 50 y.o. with > 1 ASCVD risk factors Diabetes Care Volume 40, Supplement 1, January 2017 _hearthealth More Thinking TS is a 53 year-old female who comes to her appointment today saying her best friend just had a heart attack out of no where she seemed so healthy. TS wants to know if there are any medications she can take to prevent a heart attack. She has no significant past medical history. You tell her: a) Now you re talking my language, atorva 40 mg daily is just what the doctor ordered b) My -ometer suggests you would be a good candidate for atorva 10 mg daily c) People like you haven t really been shown to benefit from therapy you re too healthy d) I again, need more information to decide if there s anything I can offer you Utilize clinical judgement, but no evidence available to support use Adults age y.o. Insufficient evidence that screening for dyslipidemia before age of 40 has any effect on short or longer term CV outcomes Consider significant family history of early CV disease NO Adults > 76 y.o. Adults in this age group were not included in any RCTs of use for primary prevention Weak evidence suggests a potential association between very low cholesterol levels and increased mortality USPSTF Statin Recommendation Am Fam Physician Jan 15;95(2):online Is the patient between age of 40 75? YES NO Evidence does not support use Does patient have one or more of the following cardiovascular risk factors: 1. Dyslipidemia (LDL > 130 mg/dl; HDL < 40 mg/dl) 2. Diabetes 3. Hypertension 4. Smoker Calculate ASCVD Risk using pooled cohort calculator <7.5% 7.5% to 10% > 10% Evidence does not support use YES May offer a low to moderate dose (Grade C) Recommend a low to moderate dose 4

5 Statin Dose/Intensity Low-Intensity Moderate-Intensity High-Intensity Lowers LDL < 30% Lowers LDL ~30-50% Lowers LDL > 50% Simva 10 mg Atorva mg Atorva mg Prava mg Rosuva 5-10 mg Rosuva mg Lova 20 mg Simva mg Fluva mg Prava mg Pitava 1 mg Lova 40 mg Fluva XL 80 mg Fluva 40 mg twice daily Pitava 2-4 mg Younger Patients Younger than 40 years of age Screening for dyslipidemia < 40 years of age had no effect: Short-term cardiovascular outcomes Long-term cardiovascular outcomes No studies evaluated effects of: Screening vs. not screening Treating vs. not treating Delayed vs. earlier treatment USPSTF makes no recommendation for or against screening for dyslipidemia in those 21 to 39 years of age Risk vs. benefit analysis even more patient-specific in this age group J Am Coll Cardiol Nov 7. pii: S (13) _youngpatient Older Patients Trial Age Intervention Results PROSPER* y.o. Prava 40 mg/d 31% > 70 JUPITER y.o. (n~5000) HOPE-3 50% >65 y.o. (n~6300) Rosuva 20 mg/d Rosuva 10 mg/d STAREE > 70 y.o. Atorva 40 mg/d No effect on primary composite outcome of coronary death, nonfatal MI, fatal/nonfatal stroke Statins were protective against MI, unstable angina, stroke, arterial revascularization or CV death Rates of all-cause death not different Adverse events more common in group Statins were protective against death, CV death, nonfatal MI and stroke Two co-primary clinical endpoints 1. All-cause death, dementia, or development of disability 2. Major adverse CV events (MI, ischemic stroke, CV death) * Additional risk factors: smoking, HTN, DM CRP > 2.0 mg/l; stopped early which limits results with regards to adverse effects Ongoing trial in Australia; results expected around 2020; excluded those with DM JAMA November 15; 316(19): _heartanddiabetes_cartoon Statins: Patients With Diabetes Who Else Could Benefit? < 40 y.o y.o. > 75 y.o. Without additional ASCVD risk factors N/A Moderate-intensity (Grade A) Moderate-intensity With additional ASCVD risk factors Moderate- to highintensity (Grade C) High-intensity Moderate- to highintensity Diabetes Care Volume 40, Supplement 1, January 2017 Circulation. 2012;125:

6 Myalgias Statin Adverse Effects % reported incidence depending on agent Meta-analysis of RCTs demonstrated similar degree of myalgias in patients taking placebo Reasonable to obtain baseline creatinine kinase (CK); only check again if suspicious for rhabdomyolysis Can try alternative if myalgias develop Statin Adverse Effects New-onset diabetes Very small increased risk of developing new-onset DM Meta-analysis of primary prevention trials demonstrate: 0.1 cases/100 patients years with moderate-intensity 0.3 cases/100 patient years with high-intensity 33% of patients have ASCVD Heart disease deaths account for 23.5% of deaths as of 2008 Cognitive impairment No clear relationship between decreased cognitive function and use Am Heart J 2014; 168:6 _petergriffin_injury JAMA. 2016;316(19): Supplements Omega-3 fatty acids Docosahexaenoic acid (DHA): 1.25 to 4 grams daily Eicosapentaenoic acid (EPA): 600 mg three times daily (1.8 g/day) GI intolerance, belching, fishy taste, prolonged bleeding, bruising Ethyl-EPA only formulation shown to reduce mortality in patients with coronary artery disease (CAD) Supplements English walnuts Increased dietary consumption of walnuts and other nuts may decrease risk of CAD Basis behind much of the Mediterranean diet 8-11 walnuts per day (30-56 g/day) when substituted for other dietary fats Green tea Epidemiological evidence suggests a 28% reduction in CAD risk Dose/amount very difficult to ascertain for CV benefit Supplements A few other supplements have some data supporting their use in patients with established cardiovascular disease: Magnesium may decrease anginal symptoms in those with CAD L-carnitine may improve symptoms of heart failure Ribose may improve heart s tolerance to ischemia in those with CAD A number of supplements have been shown to be ineffective or have insufficient evidence to recommend for prevention of ASVCD Coconut oil, cranberry, DHEA, Dong Quai, garlic, L-arginine, pomegranate, Reishi mushroom, zinc, citrus bergamot, fenugreek, red yeast rice, Hawthorne extract, ginseng Importantly, a number of these have potentially severe adverse effects associated with them Cautious with caffeine content 6

7 Summary Primary prevention of cardiovascular disease is much less studied and understood compared to secondary prevention Appropriately stratifying a patient s perceived ASCVD risk is essential for helping guide decisions for ASCVD prevention Aspirin, when taken for > 10 years can be a viable option for preventing ASCVD in appropriately selected patients Statins, in a similar manner, can be effective at reducing ASCVD risk in patients who meet a prespecified risk criteria Discussions with patients about the risks and benefits of therapy are paramount in making appropriate therapeutic decisions 7

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