4/24/15. AHA/ACC 2013 Guideline Key Points

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1 Review of the ACC/AHA 2013 Guidelines Anita Ralstin, MS, CNS, CNP Next Step Health Consultant, LLC 1! Discuss the rationale for the change in lipid guidelines and how that affects the decision to implement pharmacologic therapy.! Identify the 4 groups recommended for lipid management.! Implement the use of the risk calculator to identify those patients who need statin therapy.! Name statin medications and doses in the high, intermediate and low intensity categories.! Review patient education regarding side effects and how to manage.! Discuss the need for follow up testing in monitoring statin therapy.! Discuss barriers to medication adherence. 2 AHA/ACC 2013 Guideline Key Points Encourage adherence to a heart-healthy lifestyle. Statin therapy is recommended for adults in groups demonstrated to benefit. Statins have an acceptable margin of safety when used in properly selected individuals and appropriately monitored. Engage in a clinician-patient discussion before initiating statin therapy, especially for primary prevention. 1

2 Key Points (cont.)! Use the newly developed Pooled Cohort Equations for estimating 10-year ASCVD risk.! Initiate the appropriate intensity of statin therapy to reduce ASCVD risk.! Evidence is inadequate to support treatment to specific LDL-C or non-hdl-c treatment goals.! Regularly monitor patients for adherence to lifestyle and appropriate intensity of statin therapy.! n-statin drug therapy may be considered in selected individuals.! Goal: treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults, currently the leading cause of death and disability in America! About 610,000 people die of heart disease in the US every year that s 1 in every 4 deaths.! Heart disease is the leading cause of death for both men and women.! Coronary heart disease is the most common type of heart disease, killing over 370,000 per year.! Every year about 735,000 Americans have a heart attack. Of these, 525,000 are a first heart attack. Adapted from: Centers for Disease Control 6 2

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4 Liver (Intake) (Excretion) ABCA1 (Esterification) HMG CoA Reductase (Synthesis) (Bile Acids) (Micellar Cholesterol) (Uptake) 11! Improve endothelial function! Enhance the stability of atherosclerotic plaques! Decrease oxidative stress and inflammation! Inhibit the thrombogenic response.! Beneficial extrahepatic effects on the immune system, CNS, and bone. 12 4

5 ! Initiate either moderate-intensity or high-intensity statin therapy for patients who fall into the four categories! Unlike ATP-III, Do not titrate to a specific LDL cholesterol target! Measure lipids during follow-ups to assess adherence to treatment, not to achieve a specific LDL target! Individuals with clinical ASCVD! Individuals with LDL >190! Individuals with DM, y.o. with LDL and without clinical ASCVD! Individuals without clinical ASCVD or DM with LDL and estimated 10-year ASCVD risk >7.5% Summary of Statin Initiation Recommendations to Reduce ASCVD Risk (Revised Figure) 5

6 Summary of Statin Initiation Recommendations to Reduce ASCVD Risk (Revised Figure) Risk-Estimator/ 17 Intensity of Statin Therapy *Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice. There might be a biologic basis for a less-than-average response. Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in IDEAL (Pedersen et al). Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA due to the increased risk of myopathy, including rhabdomyolysis. 6

7 ! Select the appropriate dose.! Keep potential side effects and drug-drug interaction in mind (grade A).! If high or moderate intensity statin not tolerated, use the maximum tolerated dose.! Conditions that could predispose patients to statin side effect: o Impaired renal or hepatic function o History of previous statin intolerance or muscle disorder o Age >75 o Unexplained ALT elevation > 3x ULN o History of hemorrhagic stroke o Asian ancestry! Check baseline ALT prior initiating the statin (Grade B)! Check LFTs if patient develops symptoms of hepatic dysfunction! If 2 consecutive LDL <40, Consider decreasing the statin dose (Grade C, weak recommendation)! It may be harmful to initiate simvastatin 80mg, or increase the dose of simvastatin to 80mg (Grade B) 7

8 62 year old African American male! Total cholesterol: 140! HDL: 35! SBP: 130 mmhg! t taking anti-hypertensive medications! n-diabetic! n-smoker 23 Heart-healthy lifestyle habits are the foundation of ASCVD prevention. Age 21 years and a candidate for statin therapy. Clinical ASCVD Age 75 Age 75 or if not candidate for high - intensify statin Moderate -Intensity LDC-C 190 (Moderate -intensity if note candidate for high-intensity DM LDL-C Age Estimated 10 year ASCVD risk 7.5% High Intensity statin Primary prevention ( diabetes, LDL-C , and not receiving statin therapy) Estimate 10 year ASCVD risk every 4-6 years 7.5 % 10 year ASCVD risk Moderate -intensity or high-intensity statin 5% to 7.5% 10 year ASCVD risk From ACC/AHA 2013 Lipid Guidelines 24 8

9 Intensity of Statin Therapy *Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice. There might be a biologic basis for a less-than-average response. Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in IDEAL (Pedersen et al). Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA due to the increased risk of myopathy, including rhabdomyolysis. 50 year old white female! Total cholesterol 180! HDL: 50! SBP: 130! taking anti-htn meds! +diabetic! +smoker 27 9

10 Heart-healthy lifestyle habits are the foundation of ASCVD prevention. Age 21 years and a candidate for statin therapy. Clinical ASCVD Age 75 Age 75 or if not candidate for high - intensify statin Moderate -Intensity LDC-C 190 (Moderate -intensity if note candidate for high-intensity DM LDL-C Age Estimated 10 year ASCVD risk 7.5% High Intensity statin Primary prevention ( diabetes, LDL-C , and not receiving statin therapy) Estimate 10 year ASCVD risk every 4-6 years 7.5 % 10 year ASCVD risk Moderate -intensity or high-intensity statin 5% to 7.5% 10 year ASCVD risk From ACC/AHA 2013 Lipid Guidelines 28 Intensity of Statin Therapy *Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice. There might be a biologic basis for a less-than-average response. Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in IDEAL (Pedersen et al). Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA due to the increased risk of myopathy, including rhabdomyolysis. 48 year old white female! Total cholesterol 180! HDL: 55! SBP: 130! t taking anti-htn meds! +diabetic! n-smoker 10

11 31 Heart-healthy lifestyle habits are the foundation of ASCVD prevention. Age 21 years and a candidate for statin therapy. Clinical ASCVD Age 75 Age 75 or if not candidate for high - intensify statin Moderate -Intensity LDC-C 190 (Moderate -intensity if note candidate for high-intensity DM LDL-C Age Estimated 10 year ASCVD risk 7.5% High Intensity statin Primary prevention ( diabetes, LDL-C , and not receiving statin therapy) Estimate 10 year ASCVD risk every 4-6 years 7.5 % 10 year ASCVD risk Moderate -intensity or high-intensity statin 5% to 7.5% 10 year ASCVD risk From ACC/AHA 2013 Lipid Guidelines 32 Intensity of Statin Therapy *Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice. There might be a biologic basis for a less-than-average response. Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in IDEAL (Pedersen et al). Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA due to the increased risk of myopathy, including rhabdomyolysis. 11

12 22 year old white male! LDL: 195! HDL: 30! SBP: 120! t taking anti-htn meds! n-diabetic! n-smoker 35 Heart-healthy lifestyle habits are the foundation of ASCVD prevention. Age 21 years and a candidate for statin therapy. Clinical ASCVD Age 75 Age 75 or if not candidate for high - intensify statin Moderate -Intensity LDC-C 190 (Moderate -intensity if note candidate for high-intensity DM LDL-C Age Estimated 10 year ASCVD risk 7.5% High Intensity statin Primary prevention ( diabetes, LDL-C , and not receiving statin therapy) Estimate 10 year ASCVD risk every 4-6 years 7.5 % 10 year ASCVD risk Moderate -intensity or high-intensity statin 5% to 7.5% 10 year ASCVD risk From ACC/AHA 2013 Lipid Guidelines 36 12

13 Intensity of Statin Therapy *Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice. There might be a biologic basis for a less-than-average response. Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in IDEAL (Pedersen et al). Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA due to the increased risk of myopathy, including rhabdomyolysis. 66 year old white female! High Total cholesterol: 230! HDL: 85! SBP: 100! t taking anti-htn meds! n-diabetic! n-smoker 39 13

14 40 Heart-healthy lifestyle habits are the foundation of ASCVD prevention. Age 21 years and a candidate for statin therapy. Clinical ASCVD Age 75 Age 75 or if not candidate for high - intensify statin Moderate -Intensity LDC-C 190 (Moderate -intensity if note candidate for high-intensity DM LDL-C Age Estimated 10 year ASCVD risk 7.5% High Intensity statin Primary prevention ( diabetes, LDL-C , and not receiving statin therapy) Estimate 10 year ASCVD risk every 4-6 years 7.5 % 10 year ASCVD risk Moderate -intensity or high-intensity statin 5% to 7.5% 10 year ASCVD risk From ACC/AHA 2013 Lipid Guidelines 41! Statin therapy NOT recommended! Lifestyle modification (adhering to a heart healthy diet, regular exercise habits, avoidance of tobacco products, and maintenance of a healthy weight) remains a critical component of health promotion and ASCVD risk reduction! Monitor for adherence 14

15 New Perspective on LDL& n HDL Lack of RCT evidence to support titration of drug therapy to specific LDL-C and/or non HDL-C goals Strong evidence that appropriate intensity of statin therapy should be used to reduce ASCVD risk in those most likely to benefit Quantitative comparison of statin benefits with statin risk n-statin therapies did not provide ASCVD risk reduction benefits or safety profiles comparable to statin therapy Why t Continue to Treat to Target? Current RCT data do not indicate what the target should be Unknown magnitude of additional ASCVD risk reduction with one target compared to another Unknown rate of additional adverse effects from multidrug therapy used to achieve a specific goal Therefore, unknown net benefit from treat-totarget approach Clinical ASCVD: Initiating Statin Therapy *Fasting lipid panel preferred. In a nonfasting individual, a nonfasting non-hdl C 220 mg/dl may indicate genetic hypercholesterolemia that requires further evaluation or a secondary etiology. If nonfasting triglycerides are 500 mg/dl, a fasting lipid panel is required. It is reasonable to evaluate the potential for ASCVD benefits and for adverse effects, and to consider patient preferences, in initiating or continuing a moderate- or highintensity statin, in individuals with ASCVD >75 years of age. 15

16 Monitoring Response-Adherence NO RECOMMENDATIONS ON STATIN THERAPY FOR PTS WITH NYHA CLASS II-IV OR ESRD ON DIALYSIS! Muscle Pain! Diabetes Evaluate for metabolic syndrome! Cognitive Changes Data equivocal! Individual Concerns! Cost 48 16

17 It is reasonable to evaluate and treat muscle symptoms including pain, cramping, weakness, or fatigue in statin-treated patients To avoid unnecessary discontinuation of statins, obtain a history of prior or current muscle symptoms to establish a baseline before initiating statin therapy and check baseline CK level If unexplained severe muscle symptoms or fatigue develop during statin therapy: Promptly discontinue the statin Address possibility of rhabdomyolysis with: CK Creatinine Urinalysis for myoglobinuria If mild-to-moderate muscle symptoms develop during statin therapy: Check CK and have patient discontinue the statin for 2 weeks and have patient evaluate symptom level. If symptoms resolve, restart statin. If symptoms return, considered change in statin or dose. If symptoms don t resolve, evaluate the patient for other conditions* that might increase the risk for muscle symptoms *Hypothyroidism, reduced renal or hepatic function, rheumatologic disorders such as polymyalgia rheumatica, steroid myopathy, vitamin D deficiency or primary muscle diseases 17

18 Statin-Treated Individuals n-statin Therapy Considerations Use the maximum tolerated intensity of statin Consider addition of a nonstatin cholesterollowering drug(s) If a less-than-anticipated therapeutic response persists Only if ASCVD risk-reduction benefits outweigh the potential for adverse effects in higher-risk persons: Clinical ASCVD <75 years of age Baseline LDL-C 190 mg/dl Diabetes mellitus 40 to 75 years of age n-statin cholesterol-lowering drugs shown to reduce ASCVD events in RCTs are preferred! niacin! fibrates gemfibrozil-avoid with statin therapy! ezetimide IMPROVE-IT Study 2014! Omega-3 fatty acids! bile acid sequestrants 53! Do not focus on LDL-C or non HDL-C levels as treatment goals Use lipid panel to monitor adherence! Use medications proven to reduce ASCVD risk! Risk decisions in primary prevention require a clinician-patient discussion to evaluate the benefits and harms for the individual patient Optimal lifestyle emphasized Clinician-patient discussion needed for appropriate shared decision-making 18

19 Questions? 55 Heart-healthy lifestyle habits are the foundation of ASCVD prevention. Age 21 years and a candidate for statin therapy. Clinical ASCVD Age 75 Age 75 or if not candidate for high - intensify statin Moderate -Intensity LDC-C 190 (Moderate -intensity if note candidate for high-intensity DM LDL-C Age Estimated 10 year ASCVD risk 7.5% High Intensity statin Primary prevention ( diabetes, LDL-C , and not receiving statin therapy) Estimate 10 year ASCVD risk every 4-6 years 7.5 % 10 year ASCVD risk Moderate -intensity or high-intensity statin 5% to 7.5% 10 year ASCVD risk From ACC/AHA 2013 Lipid Guidelines 56! A downloadable spreadsheet enabling estimation of 10-year and lifetime risk for ASCVD and a webbased calculator are available at my.americanheart.org/cvriskcalculator and practice-guidelines-and-quality-standards/2013- prevention-guideline-tools.aspx.! Published guidelines found at circ.ahajournals.org/content/early/ 2013/11/11/01.cir a 57 19