Conflict of Interest Disclosure. Learning Objectives. Learning Objectives. Guidelines. Update on Lifestyle Guidelines

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1 Conflict of Interest Disclosure Updates for the Ambulatory Care Pharmacist: Dyslipidemia and CV Risk Assessment No conflicts of interest to disclose 2014 Updates to the Updates in Ambulatory Care Pharmacy Webinar Cardiology II Updates for Ambulatory Care Pharmacists Karen J. McConnell, PharmD, FCCP, BCPS (AQ Cardiology) Kaiser Permanente Colorado University of Colorado Skaggs School of Pharmacy February 26, 2014 Learning Objectives Recommend lifestyle management to reduce cardiovascular risk based on the 2013 ACC/AHA guidelines Calculate 10 year and lifetime risk of atherosclerotic cardiovascular disease (ASCVD) using the pooled cohort equation from the 2013 ACC/AHA guidelines Learning Objectives Create an evidence-based medication regimen to treat cholesterol for primary and secondary prevention based on the 2013 ACC/AHA cholesterol guidelines Develop a treatment strategy for dyslipidemia for patient with chronic kidney disease based on the 2013 Kidney Disease Improving Global Outcomes (KDIGO) guidelines 2013 ACC/AHA Guideline for Cholesterol Treatment 2013 ACC/AHA Guideline for Lifestyle Management to Reduce CV Risk 2013 ACC/AHA Guideline on the Assessment of CV Risk 2013 KDIGO Guideline for Lipid Management in Chronic Kidney Disease Update on Lifestyle Consume a diet that Emphasizes vegetables, fruits, and whole grains Includes low-fat dairy products, poultry, fish, legumes, nontropical vegetable oils and nuts Limits intake of sweets, sugar-sweetened beverages and red meats AHA/ACC guideline on lifestyle management. Circulation. 2013;00:

2 Update on Lifestyle Aim for a dietary pattern that achieves 5% to 6% of calories from saturated fat. Reduce percent of calories from saturated fat. Reduce percent of calories from trans fat. Update on Lifestyle BP Lowering Limit to no more than 2.4 g of sodium/day Further reduction of sodium intake to 1,500 mg/day is associated with even greater BP reduction Reduce intake by at least 1 g/day since that will lower BP Physical Activity 3 to 4 sessions weekly, averaging 40 minutes each, with moderate-to-vigorous intensity physical activity AHA/ACC guideline on lifestyle management. Circulation. 2013;00: AHA/ACC guideline on lifestyle management. Circulation. 2013;00: ASCVD Risk Assessment primary prevention Assess adults years of age at least once every 4 6 years. Age Assess risk factors. Age Use Pooled Cohort Equations. Pool cohort equation available at quality/practice-guidelines-and-quality-standards/2013- prevention-guideline-tools.aspx. Non-Hispanic African Americans and whites have sex- and race-specific Pooled Cohort Equations to predict 10-year risk of ASCVD. Consider using the non-hispanic white Pooled Cohort Equation for other populations. If risk-based treatment decisions remain unclear, consider family history, hs-crp, coronary artery calcium score, or ABI (example) Risk Factor Units Value Sex M (for males) or F (for females) f Acceptable range of values M or F Age years Race AA (for African Americans) or WH (for whites or others) wh AA or WH Optimal values Total Cholesterol mg/dl HDL-Cholesterol mg/dl Systolic Blood Pressure Treatment for High Blood Pressure (if SBP >120) Diabetes Smoker mm Hg Y (for yes) or N (for no) Y (for yes) or N (for no) Y (for yes) or N (for no) n Y or N N n Y or N N n Y or N N Your 10-Year ASCVD Risk (%) Year ASCVD Risk (%) for Someone Your Age with Optimal Risk Factor Levels Your Lifetime ASCVD Risk* (%) Lifetime ASCVD Risk (%) for Someone at Age 50 with Optimal Risk Factor Levels 10.8 This calculator only provides lifetime risk estimates for individuals 20 to 59 years of age *This is the lifetime ASCVD risk for an individual at age 50 years with your risk factor levels. In rare cases, 10-year risks may exceed lifetime risks given that the estimates come from different approaches

3 Predicted Risk (%) 10-Year and Lifetime ASCVD Risks Your 10-Year ASCVD Risk 10-Year ASCVD Risk (%) Your Lifetime ASCVD Lifetime ASCVD Risk (%) (%) for Someone Your Age with Risk* (%) for Someone at Age 50 with Optimal Risk Factor Levels Optimal Risk Factor Levels Patient Case 1 A 62-year-old African American man with HTN who smokes 1 pack/day presents to your clinic. He is currently taking amlodipine 5 mg/day. The primary care physician would like your help in addressing his cholesterol. The patient would prefer to lower his cholesterol without medications, if possible. Fasting laboratory results reveal total cholesterol 187, TG 157, HDL 43, LDL 113, non-hdl 144, FBG 85, SCr 1.0, ALT 25, Na 140, and K 4.7. His BMI is 32.5 and today his BP is 138/85 mmhg. Patient Case 1 continued 1.1. Which one of the following is the best estimate of his 10 year CV risk? A. Less than 5%. B. 5 to 10%. C. 10 to 20%. D. Greater than 20%. Risk scoring Your 10-Year ASCVD Risk (%) Year ASCVD Risk (%) for Someone Your Age with Optimal Risk Factor Levels Your Lifetime ASCVD Risk* (%) Lifetime ASCVD Risk (%) for Someone at Age 50 with Optimal Risk Factor Levels 6.5 This calculator only provides lifetime risk estimates for individuals 20 to 59 years of age *This is the lifetime ASCVD risk for an individual at age 50 years with your risk factor levels. In rare cases, 10-year risks may exceed lifetime risks given that the estimates come from different approaches. 5.0 Patient Case 1 continued 1.2. Is a statin indicated for this patient? A. Yes B. No Update on Lipid Four groups that benefit from statin therapy to reduce atherosclerotic cardiovascular disease (ASCVD) events for primary and secondary prevention based on randomized controlled trials were identified C. Maybe? 3

4 Update on Lipid 1. Clinical ASCVD acute coronary syndromes, or a history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or atherosclerotic peripheral arterial disease. Age 75 or younger high intensity statin recommended Over age 75 years moderate intensity statin recommended Statin potency comparison Atorva Fluva Pitava Lova Prava Rosuva Vytorin Simva % LDL-C / / / Denotes high-intensity statin lowers LDL-C by 50%. Denotes moderate-intensity statin lowers LDL-C by 30% to < 50%. Denotes low-intensity statin. Update on Lipid 2. Primary elevations of LDL C greater than190 mg/dl high intensity statin recommended 3. No clinical ASCVD or diabetes With LDL C 70 to189 mg/dl and Estimated 10-year ASCVD risk greater than 7.5% Aged 40 to 75 years Moderate to high intensity statin recommended. Update on Lipid 4. Diabetes aged 40 to 75 years with LDL C 70 to189 mg/dl and without clinical ASCVD Estimated 10 year risk of ASCVD at least 7.5% high intensity statin recommended Estimated 10 year risk of ASCVD less than 7.5% moderate intensity statin recommended Update on Lipid ASCVD prevention benefit of statin therapy may be less clear in other groups. May consider other risk factors for ASCVD risk Primary LDL-C of 160 mg/dl or greater or other evidence of genetic hyperlipidemias Family history of premature ASCVD with onset before 55 years of age in a first-degree male relative or before 65 years of age in a first-degree female relative Update on Lipid May consider other risk factors for ASCVD risk hs-crp greater than 2 mg/l Coronary artery calcium score of 300 Agatston units or greater or 75th percentile or greater for age, sex, and ethnicity ABI less than 0.9 Elevated lifetime risk of ASCVD 4

5 Update on Lipid Consider possible adverse effects, drug-drug interactions, and patient preferences for statin treatment. Statin adverse effects should be effectively managed Update on Lipid The panel makes no recommendations for or against specific LDL-C or Non-HDL-C goals There is no RCT evidence to support LDL-C or non HDL-C treatment targets or goals. Adherence to medication and lifestyle, therapeutic response to statin therapy, and safety 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. Update on Lipid Additional guidance is needed The benefit of non-statin therapies has not been shown to exceed the risk of ADRs. Higher ASCVD risk patients on maximum-tolerated statin with a less-than-anticipated therapeutic response, adding a non-statin drug(s) may be considered Higher-risk individuals include: Individuals with clinical ASCVD younger than 75 years Individuals with baseline LDL-C of 190 mg/dl or higher Individuals years of age with DM Treatment of hypertriglyceridemia Role of non HDL-C Role of apo B, lipoprotein (a), or LDL-C particles Role of noninvasive imaging in contributing to risk estimates Role of lifetime ASCVD risk and optimal age for statin therapy Subgroups (patients with HF or on hemodialysis) that may benefit from statin therapy Long-term effects of statinassociated new-onset diabetes and management Efficacy and safety of statins in patient groups excluded from RCTs Role of pharmacogenetic testing Patient Case 1 A 62-year-old African American man with HTN who smokes 1 pack/day presents to your clinic. He is currently taking amlodipine 5 mg/day. The primary care physician would like your help in addressing his cholesterol. The patient would prefer to lower his cholesterol without medications, if possible. Fasting laboratory results reveal total cholesterol 187, TG 157, HDL 43, LDL 113, non-hdl 144, FBG 85, SCr 1.0, ALT 25, Na 140, and K 4.7. His BMI is 32.5 and today his BP is 138/85 mmhg. Patient Case 1 continued 1.3. Is a statin indicated for this patient? A. Yes B. No 5

6 Patient Case 1 continued Statin potency comparison 1.4. Which statin and dose would you recommend? Atorva Fluva Pitava Lova Prava Rosuva Vytorin Simva % LDL-C A. Fluvastatin 40 mg/day B. Pravastatin 20 mg/day C. Simvastatin 40 mg/day D. Atorvastatin 80 mg/day / / / Denotes high-intensity statin lowers LDL-C by 50%. Denotes moderate-intensity statin lowers LDL-C by 30% to < 50%. Denotes low-intensity statin. Update on Lipid No clinical ASCVD or diabetes With LDL C 70 to189 mg/dl and Estimated 10-year ASCVD risk greater than 7.5% Aged 40 to 75 years Moderate to high intensity statin recommended. Patient Case 2 A 73-year-old white woman with diabetes presents to your clinic. She has heard that people her age should be on a statin, and wants to know if she should start taking one. She currently takes metformin 1g BID. Fasting laboratory results reveal total cholesterol 174, TG 273, HDL 29, LDL 90, non-hdl 145, SCr 0.8, ALT 30, Na 143, K 4.7, uric acid 5.5, and A1c 7.5%. Her BMI is 27.0 and her BP today is 115/70 mmhg. Patient Case 2 continued 2.1 Which one of the following is the best recommendation for this patient? A. No statin indicated. B. Start lovastatin 20 mg/day. C. Start pitavastatin 2 mg/day. D. Start atorvastatin 40 mg/day. Update on Lipid 4. Diabetes aged 40 to 75 years with LDL C 70 to189 mg/dl and without clinical ASCVD Estimated 10 year risk of ASCVD at least 7.5% high intensity statin recommended Estimated 10 year risk of ASCVD less than 7.5% moderate intensity statin recommended 6

7 Risk scoring Statin potency comparison Your 10-Year ASCVD Risk (%) 20.0 Atorva Fluva Pitava Lova Prava Rosuva Vytorin Simva % LDL-C 10-Year ASCVD Risk (%) for Someone Your Age with Optimal Risk Factor Levels Your Lifetime ASCVD Risk* (%) Lifetime ASCVD Risk (%) for Someone at Age 50 with Optimal Risk Factor Levels 9.7 This calculator only provides lifetime risk estimates for individuals 20 to 59 years of age *This is the lifetime ASCVD risk for an individual at age 50 years with your risk factor levels. In rare cases, 10-year risks may exceed lifetime risks given that the estimates come from different approaches / / / Denotes high-intensity statin lowers LDL-C by 50%. Denotes moderate-intensity statin lowers LDL-C by 30% to < 50%. Denotes low-intensity statin. Kidney Disease Improving Global Outcomes No specific LDL-C target is recommended Titrating statin doses according to LDL-C is not recommended. Recommended doses of statins in adults with CKD Atorvastatin 20 mg/day Pravastatin 40 mg/day Fluvastatin 80 mg/day Rosuvastatin 10 mg/day Lovastatin Not studied Simvastatin 40 mg/day Pitavastatin 2 mg/day Simvastatin/ezetimibe 20/10 mg/day KDIGO clinical practice guideline for lipid management in chronic kidney disease. Kidney International. 2013;3: Patient populations to be treated with statin Patients older than 50 years with an egfr < 60 ml/minute but not treated with dialysis or kidney transplant Patients older than 50 years with CKD and egfr >60 ml/minute Post kidney transplantation in adults. Statins should not be initiated in patients on dialysis unless statins started prior to dialysis initiation (continue statin) KDIGO clinical practice guideline for lipid management in chronic kidney disease. Kidney International. 2013;3: Adults younger than 50 years with CKD but not treated with dialysis or kidney transplant: Statin treatment is recommended if: Known coronary disease (MI or coronary revascularization) Diabetes mellitus Prior ischemic stroke Estimated 10-year incidence of coronary death or nonfatal MI greater than 10% Patient Case 3 A 45-year-old African American man with chronic kidney disease, hypertension and diet-controlled diabetes last year present to your clinic. He currently takes felodipine 10 mg/day, HCTZ 25 mg/day, and lisinopril 20 mg/day. His physician asks you if a statin should be started. Fasting laboratory results reveal total cholesterol 199, TG 115, HDL 39, LDL 127, non-hdl 150, SCr 3.3, CrCl (IBW) 29.2 ml/min, ALT 15, A1c 6.5%, microalbumin:creatinine 45. His BMI is 35.9 and his BP is 135/75 mmhg. KDIGO clinical practice guideline for lipid management in chronic kidney disease. Kidney International. 2013;3:

8 Patient Case 3 continued 3.1. Which one of the following is the best recommendation regarding statin therapy? A. No statin indicated. B. Start simvastatin 10 mg/day. C. Start rosuvastatin 40 mg/day. D. Start atorvastatin 20 mg/day. Adults younger than 50 years with CKD but not treated with dialysis or kidney transplant: Statin treatment is recommended if: Known coronary disease (MI or coronary revascularization) Diabetes mellitus Prior ischemic stroke Estimated 10-year incidence of coronary death or nonfatal MI greater than 10% Kidney Disease Improving Global Outcomes Recommended doses of statins in adults with CKD Atorvastatin 20 mg/day Pravastatin 40 mg/day Fluvastatin 80 mg/day Rosuvastatin 10 mg/day Lovastatin Not studied Simvastatin 40 mg/day Pitavastatin 2 mg/day Simvastatin/ezetimibe 20/10 mg/day Per Crestor package labeling, rosuvastatin dose not to exceed 10 mg/day when CrCl <30 ml/min Risk scoring Your 10-Year ASCVD Risk (%) Year ASCVD Risk (%) for Someone Your Age with Optimal Risk Factor Levels Your Lifetime ASCVD Risk* (%) 69.0 Lifetime ASCVD Risk (%) for Someone at Age 50 with Optimal Risk Factor Levels *This is the lifetime ASCVD risk for an individual at age 50 years with your risk factor levels. In rare cases, 10-year risks may exceed lifetime risks given that the estimates come from different approaches Update on Lipid 4. Diabetes aged 40 to 75 years with LDL C 70 to189 mg/dl and without clinical ASCVD Estimated 10 year risk of ASCVD at least 7.5% high intensity statin recommended Estimated 10 year risk of ASCVD less than 7.5% moderate intensity statin recommended QUESTIONS? 8