HEALTHCARE PRACTITIONERS

AN INTERACTIVE GUIDE CHOLESTEROL MANAGEMENT GUIDE FOR HEALTHCARE PRACTITIONERS

DOWNLOAD/PRINT THE COMPLETE GUIDE IN PDF FORMAT CONTENTS Key Points/Introduction... 3 Section 1 Assessing ASCVD Risk in Adults............................ 4 Communicating Risk.... 6 Section 2 When and How to Prescribe Statins... 7 Four Major Statin Benefit Groups... 7 Statin Therapy Recommendations.... 8 Intensity of Statin Therapy... 15 Monitoring of Statin Therapy... 16 Safety Considerations for Statin Therapy.... 18 Patient Discussions About Side Effects... 19 Long-Term Management.... 21 Non-Statin Pharmacotherapy... 22 Section 3 Co-Developing a Lifestyle Plan to Lower Risk... 25 3-Step Focused Lifestyle Intervention... 25 Appendix 1: Statistics... 30 Appendix 2: Communicating with Patients... 32 Appendix 3: Additional Resources... 34 2

KEY POINTS Healthcare providers should assess atherosclerotic cardiovascular disease (ASCVD) risk in adults using evidence-based tools such as the ASCVD calculator to identify those at elevated risk who might benefit from treatment. Cholesterol, a main modifiable risk factor, should be considered along with other health and lifestyle factors when assessing and calculating ASCVD risk. Statins are the first line agents used to decrease cholesterol and reduce the risk of ASCVD events Evidence supports their use in four adult groups with demonstrated benefit. Statin therapy is safe when used properly and monitored. Engage patients in the discussion before initiating statin therapy and when discussing lifestyle changes. Initiate the appropriate intensity of statin therapy to reduce ASCVD risk and regularly monitor patients for adherence to lifestyle and appropriate intensity of statin therapy. Evidence does not support treating to a specific LDL-C or non HDL-C target. Nonstatin drug therapy may be considered in combination or as monotherapy in selected individuals. INTRODUCTION In 2013 the American Heart Association (AHA), in conjunction with the American College of Cardiology (ACC), released four new ASCVD prevention guidelines in an effort to help healthcare providers provide consistent, clear, and evidence-based guidance for treating patients at risk for ASCVD. These four guidelines cover risk assessment, treatment of blood cholesterol, lifestyle management, and obesity management. While all four guidelines are important for the prevention of ASCVD, this toolkit focuses on risk assessment and cholesterol management recommendations for primary prevention for those with elevated risk or high cholesterol levels. It contains recommendations and printable tools to help you: 1. Understand ASCVD risk assessment and the use of tools such as the ASCVD Risk Calculator. 2. Understand when and how to prescribe and manage statins. 3. Understand how to prescribe and manage lifestyle. 4. Overcome common barriers to treatment. DID YOU KNOW? The focus of the 2013 AHA/ACC Guideline for Treatment on Blood Cholesterol is on primary prevention strategies to reduce a patient s risk of future ASCVD. 3

SECTION 1 ASSESSING ASCVD RISK IN ADULTS PRINT SECTION 1 One in every 3 American adults has some form of cardiovascular disease. Given the scope of the problem and its impact on public health and healthcare costs, identifying adults at elevated risk for ASCVD and treating them early is an essential step in preventing and minimizing the adverse effects of this disease. The 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk outlines recommendations for estimating atherosclerotic disease risk. Included in this guideline is the ASCVD Risk Calculator. This is an easy and useful tool to help identify patients at risk for heart attack and stroke who might benefit from preventive treatment. Note that the ASCVD Risk Calculator is for use to identify patients who would benefit from primary prevention strategies, not secondary. The ASCVD Risk Calculator calculates risk using only a specific set of factors, which include: Age Sex Race Total cholesterol HDL cholesterol Systolic blood pressure History of diabetes Smoking status Treatment for blood pressure These factors assist in identifying patients who have not had a prior ASCVD event and assign a 10-year risk score. Patients are considered to be at elevated risk if the 10-year risk score is 7.5%. When to USE the calculator: Patients 40 to 79 years of age without ASCVD Patients with LDL levels 70 to 189 mg/dl without ASCVD and not on statin therapy When NOT to use the calculator: NOT for patients <40 years of age or >79 years of age NOT for patients with established ASCVD or with symptoms suggestive of CVD NOT for patients on hemodialysis NOT for patients with advanced congestive heart failure NOT for subgroups of high-risk patients, such as those with familial hypercholesterolemia 4

An update to the ASCVD Risk Calculator called the Million Hearts Longitudinal ASCVD Risk Assessment Tool was also launched in 2016. It builds on the 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk by allowing providers to estimate the baseline and updated 10-year ASCVD risk estimates for primary prevention patients and assist in their management. It emphasizes the use of four prevention therapies called the ABCS (aspirin therapy, blood pressure control, cholesterol management, and smoking cessation) and allows providers and patients to see how risk would be affected when implementing these therapies. The ASCVD Risk calculator (and related tools) are only starting points for assessing ASCVD risk. The resulting risk scores provide a baseline to initiate an open discussion with patients and guide decisionmaking regarding treatment options to prevent ASCVD, including lifestyle changes, risk factor management, and pharmacologic treatment (i.e., statin therapy). DID YOU KNOW? You can access resources, tools and a guidelines-to-go app at http://professional. heart.org/professional/educationmeetings/ CholesterolforProfessionals/UCM_491496_ Cholesterol-for-Professionals.jsp If, after quantitative assessment, a risk-based treatment remains uncertain, healthcare providers can integrate one or more of the following additional measures into the treatment decision-making process: Family history of premature CVD: Male <55 years of age or Female <65 years of age; (1st-degree relative) High-sensitivity C-reactive protein (hs-crp) level: 2 mg/l Coronary artery calcium (CAC) score: 300 Agostin units or 75th percentile for age, sex, and ethnicity Ankle brachial index (ABI): <0.9 Results from these additional measures may help to further determine whether patients are at elevated risk for ASCVD. Providers and patients can then use this information to help select the most appropriate and effective treatments to reduce ASCVD risk. 5

COMMUNICATING RISK There are multiple ways to communicate risk, and the way it is presented can greatly influence a patient s qualitative impression of it. Use the table below on best practices for communication of ASCVD risk to facilitate your discussion with your patients. PRINT TABLE 1 Table 1. Best practices for communication of ASCVD risk Recommendation Assess patient estimated risk at baseline. Use round numbers; avoid decimals. Maintain a consistent denominator when presenting proportions. Rationale Patients may have optimistic or pessimistic biases, which may require different communication strategies. Simple numbers are easier to understand. Larger numerators lead to higher perceived risk, regardless of the denominator: patients presented with a 1 in 10 chance may consider that lower than if it were presented as 10 out of 100. Avoid using excessively small percentages. Small numbers close to zero may be perceived as no risk. Provide context for risk estimates when available, that is, high risk is more than 7.5%. Consider alternatives to 10-year risk. Limit the number of statistics/graphics when discussing risk. Utilize decision aids and visual graphics, but explain them. Putting risk into context may help improve comprehension beyond just providing numeric estimates. Lifetime or 30-year risk may be more impactful in young adults; heart age may be more motivating for behavior change. Providing too many estimates can lead to information overload. Graphics can improve comprehension but may require explanation. Avoid using number needed to treat (NNT). NNT leads to poor comprehension of benefit. Note differences in responses to relative risk and absolute risk. Relative risk reductions are perceived as greater than when presented as absolute risk reductions. Absolute risk reductions allow for direct comparisons of risks and benefits. Patient discussion tip: Use examples to help patients understand what their ACSVD 10-year risk number means. If your 10-year ASCVD risk estimate is 10%, this means that of 100 patients with the same risk factors as you, 10 would be expected to have a heart attack or stroke in the next 10 years. 6

SECTION 2 WHEN AND HOW TO PRESCRIBE STATINS PRINT SECTION 2 Statins are a class of medications that inhibit production of cholesterol in the liver. Whereas previous cholesterol guidelines emphasized the use of statin therapy to treat to target cholesterol levels, the 2013 ACC/AHA guideline on treating blood cholesterol focuses instead on the use of statin therapy to address the broader goal of reducing ASCVD risk and events. For this reason, the guideline recommends the use of statin therapy as first-line treatment not only for highcholesterol patients but also for certain patients with known ASCVD or those with elevated risk for ASCVD. Before initiating statin treatment in any patient, it should be emphasized that lifestyle changes (i.e., following a heart-healthy diet, exercising regularly, quitting and avoiding tobacco use, and maintaining a healthy weight) are a critical component of ASCVD prevention as well as cholesterol management. These areas require a thorough discussion and implementation to the extent recommended by the patient s risk assessment and dictated by the patient s level of compliance. Statins are the next focus of cholesterol management and/or risk reduction. The guideline identifies four major groups of individuals ( 21 years old) as potentially benefitting from statins. For these groups, ASCVD risk reduction clearly outweighs the risk of adverse effects based on a strong body of evidence. Four Major Statin Benefit Groups 1. Individuals with clinical ASCVD (i.e. acute coronary syndrome, or a history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin) 2. Individuals with primary elevations of LDL-C 190 mg/dl 3. Individuals 40 75 years of age with diabetes and LDL-C 70 189 mg/dl without clinical ASCVD 4. Individuals without clinical ASCVD or diabetes who are 40 75 years of age and have LDL-C 70 189 mg/dl and an estimated 10-year ASCVD risk of 7.5%. (Clinician-patient discussion recommended before initiation of statin therapy). 7

Statin Therapy Recommendations Recommendations for statin therapy in the four major statin benefit groups are summarized here and in Table 2. The use of statins in the group with known ASCVD is considered secondary prevention; and the use of statins in the other groups without ASCVD is considered primary prevention. An algorithm for determining appropriate statin therapy for individuals in these groups is presented in Figure 5 (see page 14). PRINT FIGURE 1 Heart-healthy lifestyle habits are the foundation of ASCVD prevention A candidate for statin therapy Figure 1 STATIN MANAGEMENT CLINICAL ASCVD Not currently on statin therapy Initial evaluation prior to statin initiation H & P Fasting lipid panel* ALT Hemoglobin A1c (if diabetes status unknown) CK (if indicated) Consider evaluation for other secondary causes (Table 6) or conditions that may influence statin safety (Table 8, Rec 1). Evaluate and Treat Laboratory Abnormalities 1. Triglycerides 500 mg/dl 2. LDL-C 190 mg/dl Secondary causes (Table 6) If primary, screen family for FH 3. Unexplained ALT 3 x ULN Clinical ASCVD Age 75 y without contraindications, conditions or drug-drug interactions influencing statin safety, or a history of statin intolerance Age >75 y with conditions or drug-drug interactions influencing statin safety, or a history of statin intolerance Initiate high-intensity statin therapy Counsel on healthy lifestyle habits Initiate moderate-intensity statin therapy Counsel on healthy lifestyle habits 1. Potential for ASCVD risk-reduction benefits 2. Potential for adverse effects and drug-drug interactions 3. Heart-healthy lifestyle 4. Management of other risk factors No to statin Encourage adherence to lifestyle Manage other risk factors Monitor adherence Clinical Patient Discussion 5. Patient preferences 6. If decision is unclear, consider primary LDL-C 160 mg/ dl, family history of premature ASCVD, lifetime ASCVD risk, abnormal AC score or ABI or hs-crp 2 mg/l * Yes to statin Encourage adherence to lifestyle Initiate statin as appropriate intensity Manage other risk factors Monitor adherence and statin therapy * For those in whom a risk assessment is uncertain, consider factors such as primary LDL-C 160 mg/dl or other evidence of genetic hyperlipidemias, family history of premature ASCVD with onset <55 years of age in a first-degree male relative or <65 years of age in a first-degree female relative, hs-crp 2 mg/l, CAC score 300 Agatston units, or 75th percentile for age, sex, and ethnicity (for additional information, see http://www.mesa-nhlbi.org/ CACReference.aspx), ABI <0.9, or lifetime risk of ASCVD. Additional factors that may aid in individual risk assessment may be identified in the future. 8

PRINT FIGURE 2 Figure 2 STATIN MANAGEMENT INDIVIDUALS 21 YEARS OF AGE WITH LDL-C 190 MG/DL Heart-healthy lifestyle habits are the foundation of ASCVD prevention A candidate for statin therapy Not currently on statin therapy Initial evaluation prior to statin initiation H & P Fasting lipid panel* ALT Hemoglobin A1c (if diabetes status unknown) CK (if indicated) Consider evaluation for other secondary causes (Table 6) or conditions that may influence statin safety (Table 8, Rec 1). Evaluate and Treat Laboratory Abnormalities 1. Triglycerides 500 mg/dl 2. LDL-C 190 mg/dl Secondary causes (Table 6) If primary, screen family for FH 3. Unexplained ALT 3 x ULN LDL-C 190 mg/dl No diabetes No Clinical ASCVD High-intensity statin (Moderateintensity if not a candidate) 9

PRINT FIGURE 3 Heart-healthy lifestyle habits are the foundation of ASCVD prevention A candidate for statin therapy Figure 3 STATIN MANAGEMENT INDIVIDUALS 40 75 YEARS OF AGE WITHOUT DIABETES AND WITH LDL-C 70-189 MG/DL Not currently on statin therapy Initial evaluation prior to statin initiation H & P Fasting lipid panel* ALT Hemoglobin A1c (if diabetes status unknown) CK (if indicated) Consider evaluation for other secondary causes (Table 6) or conditions that may influence statin safety (Table 8, Rec 1). No diabetes Evaluate and Treat Laboratory Abnormalities 1. Triglycerides 500 mg/dl 2. LDL-C 190 mg/dl Secondary causes (Table 6) If primary, screen family for FH 3. Unexplained ALT 3 x ULN No Clinical ASCVD Estimate 10-y ASCVD risk every 4-6 y 7.5% 10-y ASCVD risk (Moderate- or high-intensity statin) 5% to <7.5% 10-y ASCVD risk (Moderate-intensity statin) * For those in whom a risk assessment is uncertain, consider factors such as primary LDL-C 160 mg/dl or other evidence of genetic hyperlipidemias, family history of premature ASCVD with onset <55 years of age in a first-degree male relative or <65 years of age in a first-degree female relative, hs-crp 2 mg/l, CAC score 300 Agatston units, or 75th percentile for age, sex, and ethnicity (for additional information, see http:// www.mesa-nhlbi.org/cacreference.aspx), ABI <0.9, or lifetime risk of ASCVD. Additional factors that may aid in individual risk assessment may be identified in the future. Clinical Patient Discussion 1. Potential for ASCVD risk-reduction benefits 2. Potential for adverse effects and drug-drug interactions 3. Heart-healthy lifestyle 4. Management of other risk factors 5. Patient preferences 6. If decision is unclear, consider primary LDL-C 160 mg/ dl, family history of premature ASCVD, lifetime ASCVD risk, abnormal AC score or ABI or hs-crp 2 mg/l * No to statin Yes to statin Encourage adherence to lifestyle Manage other risk factors Monitor adherence Encourage adherence to lifestyle Initiate statin as appropriate intensity Manage other risk factors Monitor adherence and statin therapy 10

PRINT FIGURE 4 Figure 4 STATIN MANAGEMENT INDIVIDUALS 40 75 YEARS OF AGE WITH DIABETES AND LDL-C 70-189 MG/DL Heart-healthy lifestyle habits are the foundation of ASCVD prevention A candidate for statin therapy Not currently on statin therapy Initial evaluation prior to statin initiation H & P Fasting lipid panel* ALT Hemoglobin A1c (if diabetes status unknown) CK (if indicated) Consider evaluation for other secondary causes (Table 6) or conditions that may influence statin safety (Table 8, Rec 1). Evaluate and Treat Laboratory Abnormalities 1. Triglycerides 500 mg/dl 2. LDL-C 190 mg/dl Secondary causes (Table 6) If primary, screen family for FH 3. Unexplained ALT 3 x ULN Diabetes No Clinical ASCVD 10 year ASCVD risk 7.5% NO YES Moderateintensity statin High-intensity statin 11

Table 2: Summary of Key Recommendations for the Treatment of Blood Cholesterol to Reduce ASCVD Risk in Adults Recommendations COR LOE A. Heart-healthy lifestyle habits should be encouraged for all individuals B. The appropriate intensity of statin therapy should be initiated or continued: 1. Clinical ASCVD a. Age 75 y and no safety concerns: High-intensity statin I A b. Age >75 y or safety concerns: Moderate-intensity statin I A 2. Primary prevention Primary LDL-C 190 mg/dl a. Rule out secondary causes of hyperlipidemia (Table 6) I B b. Age 21 y: High-intensity statin I B c. Achieve at least a 50% reduction in LDL-C IIa B d. LDL-C lowering nonstatin therapy may be considered to further reduce LDL-C IIb C 3. Primary prevention Diabetes 40 75 years of age and LDL-C 70 189 mg/dl a. Moderate-intensity statin I A b. Consider high-intensity statin when 7.5% 10-y ASCVD risk using the Pooled Cohort Equations 4. Primary prevention No diabetes 40 75 years of age and LDL-C 70 189 mg/dl IIa B a. Estimate 10-y ASCVD risk using the Risk Calculator based on the Pooled Cohort Equations in those NOT receiving a statin; estimate risk every 4 6 y b. To determine whether to initiate a statin, engage in a clinician-patient discussion of the potential for ASCVD risk reduction, adverse effects, drug drug interactions, and patient preferences c. Re-emphasize heart-healthy lifestyle habits and address other risk factors I A i. 7.5% 10-y ASCVD risk: Moderate- or high-intensity statin IIa B ii. 5 to <7.5% 10-y ASCVD risk: Consider moderate-intensity statin IIb C I IIa B C iii. Other factors may be considered : LDL-C 160 mg/dl, family history of premature ASCVD, hs-crp 2.0 mg/l, CAC score 300 Agaston units, ABI <0.9, or lifetime ASCVD risk 5. Primary prevention when LDL-C <190 mg/dl and age <40 or >75 y, or <5% 10-y ASCVD risk a. Statin therapy may be considered in selected individuals 6. Statin therapy is not routinely recommended for individuals with NYHA class II-IV heart failure or who are receiving maintenance hemodialysis IIb C Refer to page 35 for applying the Class of Recommendation and Level of Evidence. 12

Recommendations COR LOE C. Regularly monitor adherence to lifestyle and drug therapy with lipid and safety assessments 1. Assess adherence, response to therapy, and adverse effects within 4 12 wk following statin initiation or change in therapy a. Measure a fasting lipid panel I A b. Do not routinely monitor ALT or CK unless symptomatic IIa C I A c. Screen and treat type 2 diabetes according to current practice guidelines. Hearthealthy lifestyle habits should be encouraged to prevent progression to diabetes d. Anticipated therapeutic response: approximately 50% reduction in LDL-C from baseline for high-intensity statin and 30% to <50% for moderate-intensity statin i. Insufficient evidence for LDL-C or non-hdl-c treatment targets from RCTs ii. For those with unknown baseline LDL-C, an LDL-C <100 mg/dl was observed in RCTs of high-intensity statin therapy e. Less than anticipated therapeutic response: I IIa B B i. Reinforce improved adherence to lifestyle and drug therapy I A ii. Evaluate for secondary causes of hyperlipidemia if indicated (Table 6) I A iii. Increase statin intensity, or if on maximally-tolerated statin intensity, consider additions of nonstatin therapy in selected high-risk individuals f. Regularly monitor adherence to lifestyle and drug therapy every 3 12 mo once adherence has been established. Continue assessment of adherence for optimal ASCVD risk reduction and safety 1. If there are muscle or other symptoms, establish that they are related to the statin I B 2. For specific recommendations on managing muscle symptoms (Table 8) IIa B IIb I C A *Clinical ASCVD includes acute coronary syndromes, history of ML stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin. Estimated 10-year or hard ASCVD risk includes first occurrence of nonfatal MMI, CHD death, and nonfatal and fatal stroke as used by the Risk Assessment Work Group in developing the Pooled Cohort Equations (http://my.americanheart.org/ cvdriskcalculator and http://www.cardiosource.org/en/science-and-quality/practice-guidelines-and-quality-standards/2013- Prevention-Guidelines-Tools.aspx). These factors may include primary LDL-C 160 mg/dl or other evidence of genetic hyperlipidemias; family history of premature ASCVD with onset <55 years of age in a first-degree male relative or <65 years of age in a first-degree female relative; hs-crp 2 mg/l; CAC score 300 Agaston units or 75th percentile for age, sex, and ethnicity (for additional information, see http:// www.mesa-nhlbi.org/cacreference.aspx); ABI < 0.9; or lifetime risk of ASCVD. Additional factors that might aid in individual risk assessment could be identified in the future. High-risk individuals include those with clinical ASCVD, an untreated LDL-C 190 mg/dl suggesting genetic hypercholesterolemia, or individuals with diabetes 40 to 75 years of age and LDL-C 70 to 189 mg/dl. ABI indicates ankle-brachial index; ACC, American College of Cardiology; AHA, American Heart Association; ALT, alanine aminotransferase, a test of hepatic function; ASCVD, atherosclerotic cardiovascular disease; CAC, coronary artery calcium; CHD, coronary heart disease; CK, creatinine kinase, a test of muscle injury; COR, Class of Recommendation; HDL-C, high-density lipoprotein cholesterol; hs-crp, high-sensitivity C-reactive protein; LDL-C, low-density lipoprotein cholesterol; LOE, Level of Evidence; NHLBI, National Heart, Lung, and Blood Institute; NYHA, New York Heart Association; RCTs, randomized controlled trials; and TIA, transient ischemic attack. 13

Figure 5. Heart-healthy lifestyle habits are the foundation of ASCVD prevention (See 2013 AHA/ACC Lifestyle Management Guideline) Age 21 y and a candidate for statin therapy Yes Clinical ASCVD Yes Age 75 y High-intensity statin (Moderate-intensity statin if not candidate for high-intensity statin) No Yes Age >75 y OR if not candidate for highintensity statin Moderate-intensity statin Definitions of High- and Moderate- Intensity Statin Therapy * (See Table 5) High Daily dose lowers LDL-C by approx.. 50% Moderate Daily dose lowers LDL-C by approx.. 30% to <50% LDL-C 190 mg/dl No Yes High-intensity statin (Moderate-intensity statin if not candidate for high-intensity statin) Regularly monitor adherence to lifestyle and drug therapy with lipid and safety assessments (See Fig. 5) Diabetes LDL-C 70-189 mg/dl Age 40-75 y Yes Yes Moderate-intensity statin Estimated 10-y ASCVD risk 37.5% High-intensity statin No DM age <40 or >75 y or LDL-C <70 mg/dl Primary prevention (No diabetes, LDL-C 70 to 189 mg/dl, and not receiving statin therapy) Estimate 10-y ASCVD risk every 406 u using Pooled Cohort Equations <5% 10-y ASCVD risk Age <40 or >75 y and LDL-C <190 mg/dl 7.5% 10-y ASCVD risk (Moderate- or highintensity statin) 5% to <7.5% 10-y ASCVD risk (Moderate-intensity statin) In selected individuals, additional factors may be considered to inform treatment decision making Clinician-Patient Discussion Prior to initiating statin therapy, discuss 1. Potential for ASCVD risk-reduction benefits 2. Potential for adverse effects and drug-drug interactions 3. Heart-healthy lifestyle 4. Management of other risk factors 5. Patient preferences 6. If decision is unclear, consider primary LDL-C 160 mg/dl, family history of premature ASCVD, liftetime ASCVD risk or ABI, OR HS-CRP 2 MG/L Emphasize adherence to lifestyle Manage other risk factors Monitor adherence No to statin Yes to statin Encourage adherence to lifestyle Initiate statin at appropriate intensity Manage other risk factors Monitor adherence * (See Fig. 5) 14

Intensity of Statin Therapy Intensity of statin therapy is defined based on the average LDL-C response to a specific statin dose. High-intensity statin therapy reduces ASCVD events more than moderate-intensity therapy, but lower-intensity statin therapy has also been shown to reduce ASCVD events, although to a lesser degree. To ensure that patients receive the most benefit from statin therapy, patients should generally be treated with the maximum appropriate intensity of a statin that is tolerated, provided there are no contraindications or safety issues, such as drug-drug interactions. Table 3 provides a summary of the medications that constitute high-, moderate-, and low-intensity statin therapy and their recommended dosages. Table 3. High-, Moderate-, and Low-Intensity Statin Therapy (Used in the RCTs Reviewed by the Expert Panel) * High-Intensity Statin Therapy Moderate-Intensity Statin Therapy Therapy Daily dose lowers LDL-C, on average, by approximately 50% Atorvastatin (40 ) 80 mg Rosuvastatin 20 (40) mg Daily dose lowers LDL-C, on average, by approximately 30% to <50% Atorvastatin 10 (20) mg Rosuvastatin (5) 10 mg Simvastatin 20 40 mg Pravastatin 40 (80) mg Lovastatin 40 mg Fluvastatin XL 80 mg Fluvastatin 40 mg BID Pitavastatin 2 4 mg Low-Intensity Statin Daily dose lowers LDL-C, on average, by <30% Simvastatin 10 mg Pravastatin 10 20 mg Lovastatin 20 mg Fluvastatin 20 40 mg Pitavastatin 1 mg PRINT TABLE 3 Boldface type indicates specific statins and doses that were evaluated in RCTs included in CQ1, CQ2, and the Cholesterol Treatment Trialists 2010 meta-analysis included in CQ3. All these RCTs demonstrated a reduction in major cardiovascular events. Italic type indicates statins and doses that have been approved by the FDA but were not tested in the RCTs reviewed. BID indicates twice daily; CQ, critical question; FDA, Food and Drug Administration; LDL-C, low-density lipoprotein cholesterol; and RCTs, randomized controlled trials. *Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice. There might be a biological basis for a less-than-average response. Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in the IDEAL (Incremental Decrease through Aggressive Lipid Lowering) study. Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA because of the increased risk of myopathy, including rhabdomyolysis. 15

Monitoring of Statin Therapy Adherence to medication and lifestyle changes, therapeutic response to statin therapy, and adverse effects should be regularly assessed. This should also include a fasting lipid panel performed within 4 12 weeks after initiation or dose adjustment and every 3 12 months thereafter. Other safety measurements should be measured as clinically indicated. The algorithm in Figure 6 provides guidance for monitoring therapeutic response and adherence to statin therapy. Figure 6. Statin Therapy: Monitoring Theraputic Response and Asherence Assess medication and lifestyle adherence Fasting lipid panel* Anticipated therapeutic response? Indicators of anticipated therapeutic response and adherence to selected statin therapy: High-intensity statin therapy reduces LDL-C approx. >50% from the untreated baseline. Moderate-intensity statin therapy reduces LDL-C approx. 30% to <50% from the untreated baseline. Yes No Reinforce continued adherence Follow-up 3-12 mo Less-than-anticipated therapeutic response Yes Anticipated therapeutic response? No Intolerance to recommended dose of statin therapy? Yes Management of statin intolerance (Table 8, Rec 8) Reinforce improved adherence Increase statin intensity OR Consider addition of nonstatin drug therapy Follow-up 4-12 wk & thereafter as indicated No Reinforce medication adherence Reinforce adhereance to intensive lifestyle changes Exclude secondary causes of hypercholesterolemia (Table 6) Follow-up 4-12 wk * Fasting lipid panel preferred. In a non-fasting individual, a non HDL-C level 220 mg/dl may indicate genetic hypercholesterolemia that requires further evaluation or a secondary etiology. If non-fasting triglycerides are 500 mg/ dl, a fasting lipid panel is required. The Pooled Cohort Equations can be used to estimate 10-year ASCVD risk in individuals with and without diabetes. These factors may include primary LDL C >160 mg/dl or other evidence of genetic hyperlipidemias, family history of premature ASCVD with onset <55 years of age in a first degree male relative or <65 years of age in a first degree female relative, sensitivity-c-reactive protein >2 mg/l 300 Agatston units or 75 percentile for age, sex, and ethnicity (For additional information, see http://www.mesa-nhlbi.org/cacreference.aspx), ABI <0.9, or lifetime risk of ASCVD. Additional factors that may aid in individual risk assessment may be identified in the future. 1) Potential ASCVD risk reduction benefits (e.g., absolute risk reduction from moderate- or high-intensity statin therapy can be approximated by using the estimated 10-year ASCVD risk and the relative risk reduction of ~30% for moderate-intensity statin or ~45% for high-intensity statin therapy. 2) Potential adverse effects. The excess risk of diabetes is the main consideration in ~0.1 excess case per 100 individuals treated with a moderate-intensity statin for 1 year and ~0.3 excess cases per 100 individuals treated with a high-intensity statin treated patients for 1 year. Note: A case of diabetes is not considered equivalent to a fatal or nonfatal MI or stroke. Both statin-treated and placebo-treated participants experienced the same rate of muscle symptoms. The actual rate of statin-related muscle symptoms in the clinical population is unclear. Muscle symptoms attributed to statin should be evaluated in Table 8, Safety Rec 8. 16

HDL-C indicates high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; RCTs, randomized clinical trials; ABI, ankle-brachial index; ALT, alanine transaminase; ASCVD indicates atherosclerotic cardiovascular disease; CK, creatine kinase; FH, familial hypercholesterolemia; LDL C, lowdensity lipoprotein cholesterol; and ULN, upper limit of normal. Key Points to Monitoring Statin Effects and Side Effects include: First review heart-healthy lifestyle habits Assess adherence Response to therapy Adverse effects within 4 to 12 weeks following statin initiation or change in therapy Measure fasting lipid levels Unless symptomatic, do not routinely monitor creatine kinase levels If ALT and/or AST are 3x ULN, decrease or stop statin and consider other causes of liver disease; otherwise when statin dose is optimized and ALT and AST are 3x ULN normal liver enzymes do not need to be repeated. Screen for and treat type 2 diabetes according to current guidelines 17

Safety Considerations for Statin Therapy Side Effects Although statins are generally well tolerated and highly effective, some patients do experience side effects. The most common are myalgias (muscle aches, pains, weakness, or cramps). These side effects are often treatable and reversible. A detailed list of adverse effects that are associated with statins can be found here. Of the ones listed, hepatoxicity, myositis, rhabdomylosis, are the most serious. Recent research linking statin use with new-onset diabetes mellitus is also of concern. To address these issues, the guideline makes specific recommendations to assess for possible side effects related to statins in here. It is reasonable to evaluate and treat muscle symptoms including pain, tenderness, stiffness, cramping, weakness, or fatigue, for example. Screening for certain problems that can occur while taking statins (e.g. new-onset diabetes mellitus) is also advised. Table 4. How to Manage Statin Intolerance Make sure there is no reversible cause such as: Medication interaction Hypothyroidism With mild symptoms, try reducing the dose of statin With intolerable symptoms, stop the statin When symptoms resolve, attempt rechallenge: Low dose of same or different statin Dose statin intermittently, for instance, 2 3 times a week Use an alternative statin (eg, fluvastatin or pravastatin) plus ezetimibe or bile acid sequestrant If symptoms return, use non statin-based cholesterol-lowering medication such as ezetimibe or bile acid sequestrant (cholestyramine or colesevelam) Encourage a healthy lifestyle in any event in all patients such as smoking cessation, weight loss, diet low in saturated fat, increased physical activity 18

Statin Intolerance and Resulting Noncompliance Some patients develop statin intolerance, an inability to use a statin. Statin intolerance is a result of unacceptable side effects (real or perceived) experierened by the patients or due to evidence from lab tests (e.g. abnormal markers of liver or muscle function), which may indicate organ dysfunction related to the statin. Patients who present with side effects or problems that lead to statin intolerance may choose to stop the medication. When faced with this situation, providers need to engage in an active discussion with their patients to determine exactly what is occurring. True intolerance to statins, as opposed to dose-titration intolerance, is rare and may possibly be resolved by evaluating and treating underlying health problems contributing to statin intolerance. To facilitate resolving issues related to statin intolerance, the guideline advises a basic algorithm to follow: see recommendation no. 8, in Table 8 of the guideline. If and when symptoms resolve after discontinuing the statin, it is reasonable to consider a statin rechallenge, if the patient is willing. In many cases this drug holiday followed by a rechallenge can result in successful treatment. Some ways to rechallenge can include: Prescribing a low dose of the same or different statin. Dosing the statin intermittently Using an alternative statin (e.g. fluvastatin or pravastatin) with exetimibe or bile acid sequestant. If symptoms do return, use of a nonstatin-based cholesterol-lowering medication such as ezetimibe or bile acid sequestrant (cholestyramine or colesevelam) is recommended. See Table 4 for a list of additional alternatives. Additionally, reinforcing and encouraging a heart-healthy lifestyle as described on page 27 can also provide benefit to the patient. Patient Discussions About Side Effects Side effects and fear of side effects such as muscle aches, pains, weakness, or cramps, are one of the primary patient barriers to initiating medication and medication adherence. Start the discussion by clearly communicating the benefits of statins in reducing incidence and risk of major ASCVD events. Ensure that the patient understands measures that will be taken to screen for and anticipate side effects, such as measurement of transaminase (alanine transaminase; ALT) levels and regular diabetes screening. Then discuss possible 19

risks, potential side effects including the probabilities of their occurrence, and discuss an action plan for dealing with any side effects with the patient. Emphasize that most side effects are harmless side effects happen to few patients taking the drugs side effects abate when the medication is stopped. The most serious side effect, muscle breakdown (rhabdomyolysis), is quite rare (~1/10,000) and typically begins with moderately severe muscle aching. Urge the patient to report this complaint immediately, which may be a signal to stop taking the medication. With progression, myoglobinuria and renal insufficiency may ensue and require hospitalization. There is no withdrawal effect from suddenly stopping these medications. Revisit the conversation about side effects regularly. A discussion of the magnitude of these risks versus the loss of benefit from the statin is an integral part of the provider-patient relationship. Involving patients in the decision-making process to arrive at a solution may help increase their compliance with the treatment plan. Muscle complaints Warn patients taking statins to report worsening muscle pain without delay. Reassure them that prompt attention to this symptom can minimize an otherwise serious side effect. Liver complaints If ALT and/or AST are 3x ULN, decrease or stop statin and consider other causes of liver disease; otherwise when statin dose is optimized and ALT and AST are 3x ULN normal liver enzymes do not need to be repeated. Diabetes Statin treatment slightly increases the risk of developing diabetes. Patient discussion tip: Use open-ended questions to discuss the patient s fears about statin therapy. What are your fears or concerns regarding statins? 20

Long-Term Management In the 2013 ACC/AHA cholesterol guideline, there was no evidence found to support the continued use of specific LDL-C or non HDL-C treatment targets. Nor was there any evidence that titrated (dose-adjusted) statin therapy or combination drug therapy to achieve specific target levels or percent reductions improved ASCVD outcomes. In addition, there was no data to support the routine use of nonstatin drugs combined with statin therapy to further reduce ASCVD events. Moreover, no RCTs were found that assessed ASCVD outcomes in statin-intolerant patients. However, providers treating high-risk patients who have any of the three responses listed below may consider the addition of a nonstatin cholesterollowering therapy. Patients with a less-than-anticipated response to statins Patients who are unable to tolerate a less-than-recommended intensity of a statin Patients who are completely statin intolerant DID YOU KNOW? Two recent trials, IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE IT) and Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial have both recently demonstrated incremental benefit when a nonstatin agent is added to statin therapy. IMPROVE IT is the first trial demonstrating a reduction in cardiovascular events when a nonstatin agent (ezetimibe) is added to statin therapy and FOURIER showed a reduction of cardiovascular events when Evolocumab was added to statin therapy in elevated risk patients High-risk patients include those with ASCVD, LDL-C 190 mg/dl, or diabetes between 40 75 years of age. In these situations, this guideline recommends clinicians preferentially prescribe drugs that have been shown in RCTs to provide ASCVD risk reduction benefits that outweigh the potential for adverse effects and drug-drug interactions along with consideration of patient preferences. Whatever decision results, emphasize the substantial and safe benefits of hearthealthy lifestyle changes. That is where the emphasis should remain. Patient discussion tip: Treating to Risk, Not Numbers Using patient-friendly language, explain that you are not recommending getting LDL-C levels down to a specific target number but rather treating the risk of future heart attack and stroke 21

Non-Statin Pharmacotherapy A number of alternatives treatments to statin therapy have proven effective in both improving lipid profiles and reducing cardiovascular events. A list of these treatments along with, dosing, actions, side effects, contraindications and clinical trial result information can be found in the table below. Proprotein convertase subtilisin/kexin 9 (PCSK9) agents are the newest, most expensive, and most dramatic reducers of LDL-C. Each class of agents has its place in the lipid armamentarium. Your knowledgeable discussion of risks and benefits of each will guide your patients to the best regimen for their unique situation. Table 5. Drugs Affecting Lipid Metabolism PRINT TABLE 5 Bile acid sequestrants Cholestyramine (4 16 g) Questran, generics Colestipol (5 20 g Colestid, generics Colesevelam (2.6 3.8 g) Welchol Nicotinic acid Immediate-release crystalline nicotinic acid (1.5 3 g) Niacor, Nicolar Extended-release nicotinic acid (1 2 g) Niaspan Sustained-release nicotinic acid (1 2 g) Slo-Niacin Lipid/Lipoprotein Effects Side Effects Contraindications Side Effects LDL-C 15% 30% LDL particle number 15% 30% HDL-C 3% 5% TG no change or increase LDL-C 5% 25% LDL particle number 10% 25% HDL-C 15% 35% HDL-P no change TG 20% 45% GI distress Constipation Decreased absorption of other drugs Flushing Hyperglycemia Hyperuricemia (or gout) Upper GI distress Hepatotoxicity Absolute: Dysbetalipoproteinemia TG >400 mg/dl Relative: TG >200 mg/dl Absolute: Unexplained hepatic dysfunction, active peptic ulcer, arterial bleeding Relative: DM Hyperuricemia Peptic ulcer disease Reduced major coronary events and CHD deaths Reduced major coronary events and possibly total mortality 22

Table 5. Drugs Affecting Lipid Metabolism Fibric acids Gemfibrozil (600 mg bid) Lopid, generics Fenofibrate (various doses) Antara, Fenoglide, Lipanthyl, Lipofen, Lofibra, Tricor, Triglide, generics Clofibrate (1,000 mg bid) generics Fenofibric acid Trilipix (35 135 mg), Fibricor (35 105 mg) Ezetimibe Zetia Lipid/Lipoprotein Effects Side Effects Contraindications Side Effects LDL-C 5% 20% (may be increased in patients with high TG) LDL particle number 5% 20% HDL-C 10% 20% HDL-P 10% TG 20% 50% LDL-C 15% 20% LDL particle number 15 25% HDL-C 1% 2% Dyspepsia Gallstones Myopathy Unexplained non-chd deaths in WHO study using clofibrate Myalgia, rare LFT values increase Absolute: Severe renal dysfunction or dialysis Active liver disease & unexplained aminase elevation Gall bladder disease Nursing mothers Previous sensitivity Reduced major coronary events No outcome trials completed TG 10% Omega-3 Lovaza (EPA + DHA) (4 g) LDL-C neutral or increase LDL-P neutral to 3% 5% (not significant in multiple trials) HDL-C neutral to 10% HDL-P 2% TG 20% 45% ApoB 4% 5% Fishy taste bleeding time which does not exceed normal limits Relative: Fish hypersensitivity Reduced mortality and sudden death in patients with history of MI, as well as patients with congestive heart failure 23

Table 5. Drugs Affecting Lipid Metabolism Vascepa (EPA) (4 g) LDL-C not increased LDL particle number 4% 15% HDL-C neutral TG 20% 45% ApoB 8.5% Lipid/Lipoprotein Effects Side Effects Contraindications Side Effects Fishy taste bleeding time which does not exceed normal limits Relative: Fish hypersensitivity Reduced nonfatal MI in Japanese patients on low-dose statin treatment Proprotein convertase subtilisin/kexin 9 (PCSK9) Alirocumab Praluent (75 mg SC Q2W) Evolocumab Repatha (140 mg Q2W or 420 mg QM LDL-C 61% LDL-C 61% Rash, urticaria, hypersensitivity vasculitis, respiratory infection, injection site reactions Rash, urticarial, respiratory infections, back pain, injection site reactions, neurocognitive vents Lower incidence of major cardiovascular events Not reported 24

SECTION 3 CO-DEVELOPING A LIFESTYLE PLAN TO LOWER RISK Three critical components of a heart-healthy lifestyle that patients can modify are activity, diet and smoking. These three factors are high impact when a patient s activity levels are appropriate; when a patient is eating a heart-healthy diet; and when a patient is not smoking. The benefits can be seen not only for hypercholesterolemia but also for hypertension, diabetes, and ASCVD Summary of Recommendations for Lifestyle Management: click here. PRINT SECTION 3 Patient discussion tip: Explain what a risk factor is in patient-friendly language A risk factor is something that, when present, increases the chance of you having a heart attack or stroke in the future. Some risk factors, such as your age and sex, you cannot change. Other risk factors, such as smoking, you can change to lower your risk. 3-Step Focused Lifestyle Intervention As the diagnosing healthcare provider, you are in an optimal position to influence the patient s behaviors and therefore help reduce their risk. This can be done in three steps: STEP 1: Identify focus areas using a Lifestyle Interview Help the patient identify lifestyle areas to focus on. These lifestyle and nutrition questions provide guidance to quickly identify actionable areas for discussion with the patient. Using the tool is easy. Either go through the list of questions with the patient, or simply pick 3 5 questions that will best serve your patient. Use the patient s answers to help launch a short conversation about lifestyle changes. Patient discussion tip: Have the patient fill out the questionnaire as a part of the intake history. 25

Lifestyle Questionnaire PRINT THIS SHEET Physical Activity How many steps do you take each day? Do you have a regular exercise program? Do you typically take elevators or escalators or climb the stairs? Do you park as close as you can to your destination? What limits your level of physical activity? Have you been evaluated for this? Would you like to become more active? Nutrition How many servings of fruits and vegetables do you eat per day? How many servings of whole grains do you eat per day? How many servings of fish do you eat per week? How often do you eat dessert? What are your favorite snack foods? Do you eat because you re hungry? Do you weigh the most now that you ve ever weighed? Are you interested in losing weight? Your goal is to: Have the discussion as soon as you can after diagnosis. Support your points with credible, evidence-based and easy-to-understand educational materials and handouts. Provide patients with a summary and schedule a follow-up appointment. Patient discussion tip: Remember to explore what benefits of the lifestyle plan matter to the patient. You might be surprised to find that the patient is more motivated by focusing on the benefit of getting better sleep than the benefit of lowering cholesterol or ASCVD risk! 26

Step 2: Provide AHA Recommendations for Focus Areas Nutrition To prevent and treat cardiovascular risk factors, a heart-healthy dietary pattern is fundamental. Such a menu emphasizes intake of vegetables, fruits, and whole grains; includes low-fat dairy products, poultry, fish, legumes, non-tropical vegetable oils and nuts; and limits intake of sweets, sugar-sweetened beverages, and red meats. Any diet prescription must be adapted to the patient s calorie requirements, personal and cultural food preferences, and nutritional restrictions for other medical conditions (such as diabetes or kidney disease). Recommended plans such as the DASH dietary pattern, the USDA Food Pattern, or the AHA Diet can be found in the Resources section of this guide. DASH and Mediterranean-style eating plans Include fruits, vegetables, and whole grains in daily menu 30-35% fat intake <6% saturated fats, no trans fats Low sodium (<2400 mg/day) Cut out processed or pre-prepared food Promote healthy eating for a lifetime Patient discussion tip: Ask patients which focus areas THEY are interested in addressing what do they think they can start today? They may not be ready to commit to a complete lifestyle overhaul but are motivated to add more whole grains. Let the patient drive the action. 27

Physical Activity Engaging in regular physical activity has numerous benefits for cardiovascular health. It can lower cholesterol and blood pressure levels, help control diabetes, and manage weight all of which help to reduce ASCVD risk. To reduce cholesterol and blood pressure levels specifically, a proper prescription for exercise should include at least 40 minutes of moderate- to vigorousintensity aerobic exercise 3-4 times a week, carefully adjusted to each patient s physical limitations (Table 6). Table 6. AHA Physical Activity Recommendation For Overall Cardiovascular Health: At least 30 minutes of moderate-intensity aerobic activity at least 5 days per week for a total of 150 minutes OR At least 25 minutes of vigorous aerobic activity at least 3 days per week for a total of 75 minutes; or a combination of moderate- and vigorous-intensity aerobic activity AND Moderate- to high-intensity muscle-strengthening activity at least 2 days per week for additional health benefits. For Lowering Blood Pressure and Cholesterol An average 40 minutes of moderate- to vigorous-intensity aerobic activity 3 or 4 times per week Patient discussion tip: Encourage the patient to start with what they feel is achievable and then build up over time. Remind them that while 30-40 min of vigorous activity is the recommendation, starting any amount of physical activity is a positive first step. 28

Step 3: Understand and Overcome Common Barriers to Treatment Anticipate that treatment barriers for patients may arise. Be sure to include or address these during your discussions with the patient. Addressing barriers or fears early aids in developing more effective and actionable management plans with your patient. Table 7. Common Barriers to Treatment PRINT TABLE 7 Common Barrier Examples Lack of education Too much information Don t know where to go for information Think cholesterol can be fixed Healthcare provider has not discussed risk Fear Lack of peer-to-peer support Social determinants, such as food insecurity, cost of fruits and vegetables, unsafe neighborhood Strategy Examples to Help Patient Overcome the Barrier AHA provides patient-friendly resources written in plain language at appropriate reading levels for the average patient. AHA s patient site pares down the information, providing an evidence-based, credible place for information. The ASCVD risk calculator gives numerical values for fixing cholesterol risk by lifestyle changes and medication. The tools/information above can be used to discuss risk, particularly the risk calculator. Patients need to be encouraged to share their feelings. Once the cause is identified, information may abate the negative emotions. It is critical to discuss preferences and goals for care with patients, friends and family. Food banks have a wide variety of nutritious foods. In addition to patient barriers, barriers for providers also exist that are often incompletely recognized such as: 1. Lipid disorders are often undiagnosed, especially in younger individuals, although early attention to this lifelong condition reaps greater rewards. 2. Statins are underutilized relative to their effectiveness. 3. Public fears about statins exceed reality and add to providers reluctance to devote sufficient time and effort to addressing patient concerns through education. Patient discussion tip: Direct patients who smoke to resources that can help them quit. Centers for Disease Control and Prevention Quit Line: www.cdc.org or American Lung Association: Freedom From Smoking: www.lung.org 29

Appendix 1: Statistics Heart disease, which encompasses coronary heart disease, hypertension and stroke, continues to be the number one cause of death in the United States. According to the American Heart Association and American Stroke Association 2017 Heart Disease and Stroke Statistical report: About 92.1 million adults currently are living with heart disease or the aftereffects of stroke. Cardiovascular disease accounts for almost 801,000 deaths in the U.S. each year and is the leading cause of death, globally. Coronary heart disease accounts for 1 in 7 deaths in the U.S.; stroke accounts for 1 of every 20 deaths. It is estimated that 790,000 Americans have a heart attack each year and 795,000 have a new or recurrent stroke. Many patients with heart disease suffer from comorbidities, making care more complex and multifaceted. Additionally, the prevalence of patients with more than one comorbidity is strikingly high (see Table 1 below), further complicating treatment. Statistics reveal that : Adults with diabetes are 2 to 4 times more likely to die from heart disease than adults without diabetes. Nearly 1 of every 3 American adults have elevated levels of LDL-C About 94.6 million (39.7%) have total cholesterol levels of 200 mg/dl or higher About 28.5 million (11.9%) have total cholesterol levels of 240 mg/dl or higher. Approximately 85.7 million or 34 % of American adults have high blood pressure. Nearly half of this group (45.6%) do not have it under control. Projections show that by 2030, about 41.4% of US adults will have hypertension, an increase of 8.4% from 2012 estimates. 30

Table 8. The 10 Most Common Comorbidities for 4 Index Cardiovascular Conditions: 2012 Data for Medicare Beneficiaries 65 Years of Age 13 Comorbidity Ischemic Heart Disease* (N=8678 060) HF* (N=4 366 489) AF* (N=2 556 839) Stroke* (N=1 145 719) Hypertension 1 (81.3) 1 (85.6) 1 (84.5) 1 (89.0) Hyperlipidemia 2 (69.1) 3 (62.6) 2 (64.4) 2 (69.9) Diabetes 3 (41.7) 5 (47.1) 7 (37.1) 6 (41.5) mellitus Arthritis 4 (40.6) 6 (45.6) 6 (41.7) 5 (44.2) Anemia 5 (38.7) 4 (51.2) 5 (43.0) 4 (46.8) HF 6 (36.3) Index 4 (50.9) 7 (37.2) Ischemic heart Index 2 (72.1) 3 (63.5) 3 (58.1) disease Chronic kidney 7 (30.2) 7 (44.8) 8 (34.4) 8 (35.2) disease Cataract 8 (21.6) 10 (22.6) COPD 9 (21.0) 8 (30.9) 9 (23.8) AF 10 (18.7) 9 (28.8) Index Alzheimer s 10 (26.3) 9 (33.8) disease/ dementia Depression 10 (29.7) Stroke Index * Data shown as rank and percentage of persons with index condition who also had a comorbidity. The percentage is included parenthetically when applicable. Comorbidity was not in the top 10 for this index condition. 13 AF indicates atrial fibrillation; COPD, chronic obstructive pulmonary disease; and HF, heart failure. 31

Appendix 2: Communicating with Patients With the added complexity of cholesterol management guidelines requiring customization to address a patient s risk and risk factors, it s even more critical to engage in a meaningful patient-provider dialogue to individualize the treatment plan, identify actionable strategies with lifestyle changes, and promote medical adherence. Shared decision-making, motivational interviewing, and the provision of patient-centered care are three models for effective patient-provider communication. Employing these communication models can be challenging initially, but practice promotes ease of use. Select only one or two skills to implement at a time. Gradually increase your repertoire of skills as your comfort level grows. Integrate the patient discussion tips provided throughout this tool kit to enhance the discussion. Shared Decision-Making Shared decision-making (SDM) refers to the process by which a treatment decision is derived through an informed discussion between a patient and healthcare provider. The success of SDM depends on clinicians having a clear understanding of the patient s preferences and priorities (See Figure 7 on page 33). Ideally, employing tips from patient-centered care and techniques from motivational interviewing can guide the SDM discussion. For successful shared decision making: Use a patient-centered care approach with the discussion (see tips on page 33) Employ motivational interviewing techniques (see tips on page 33). Support the patient s decision, integrating an understanding of the patient s goals and concerns. Motivational Interviewing Motivational interviewing involves actively encouraging a patient to examine his or her own underlying reasons for resistance to or frustration with the treatment plan. Through motivational interviewing, the patient explores the reasons for adhering to the plan, identifies the obstacles to adherence and examines methods to address and overcome these obstacles. 32

3 quick tips for successful motivational interviewing Ask the patient to identify behaviors that he or she feels ready to change. Ask the patient about what might be interfering with or barring his or her ability or desire to change. Help the patient strategize ways to overcome the barriers. Patient-Centered Care Patient-centered care is care that is respectful and responsive to individual preferences, needs, and values. Patient-centered care focuses on what the patient views as important and ensures that what the patient values guides the treatment plan. 3 quick tips for providing patient-centered care Respect the patient s voiced preferences, needs and values. Provide reliable and understandable information to the patient. Involve the patient s family and friends, as appropriate. FIGURE 7 Shared decision-making for cardiovascular disease prevention. The figure shows four components of the patient-provider discussion addressing cardiovascular disease prevention. Patient perceived risk Severity and worry about CVD Self-efficacy/desire for autonomy Prior experience Cost factors Assess Complelling priorities patient priorities Risk factor burden and CVD risk Contraindications to therapy Guidelines and new clinical data trials Additional information for risk stratafication Determine recommendation Decision aids when Arrive at shared available decision Patient as maker Re-address at subsequent visits Monitor adherance/response Communicate Patient risk of CVD risks and Benefits of risk benefits reduction Alternatives to therapy Risks of therapy Strategies to minimize risk Other risk factors 33

Appendix 3: Additional Resources Table 9. Resources and Information for Dietary and Physical Activity DASH Eating Plan Your Guide to Lowering Your Blood Pressure AHA Diet and Lifestyle Recommendations 2013 Lifestyle Management Guideline Recommended Dietary Pattern to Achieve Adherence to the American Heart Association/American College of Cardiology (AHA/ACC) Guidelines: A Scientific Statement From the American Heart Association (2016) Mediterranean Diet Dietary Guidelines for Americans 2015-2020 Dietary Guidelines for Americans Physical Activity Be Active Your Way (Physical Activity Consumer Brochure) Office of Disease Prevention and Health Promotion: 2017 Physical Activity Guidelines American Heart Association Recommendations for Physical Activity in Adults 34

DOWNLOAD/PRINT THE COMPLETE GUIDE IN PDF FORMAT Table 10. Applying Classification of Recommendation and Level of Evidence A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even when randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. *Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. For comparative effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated. 35