Reducing ASCVD Risk Focus on Lipids. Carol Marsh, DNP, APRN, CNP, FPCNA Clinical Lipid Specialist

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1 Reducing ASCVD Risk Focus on Lipids Carol Marsh, DNP, APRN, CNP, FPCNA Clinical Lipid Specialist

2 By age 2, many children have one or more risk factors for heart disease. At 40 years old, the lifetime risk of coronary heart disease is one in two for men and one in three for women.

3 I have no actual or potential conflict of interest in relation to this program/presentation. Disclosure

4 14% 18 % >70% Stenosis (14%) 68% 50-70% Stenosis (18%) <50% Stenosis (68%) Coronary Artery Stenosis Prior to Myocardial Infarction

5 Utilize Pooled Cohort Equations and additional assessments, as appropriate, to determine a patient s cardiovascular risk. Compare and contrast 2013 ACC/AHA Guidelines for the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults and the NLA Recommendations for Patient-Centered Management of Dyslipidemia. Select appropriate cardiovascular risk reduction strategies for individual patients. Objectives

6 September 1987: Mevacor (lovastatin) received FDA approval 2001 NCEP Adult Treatment Panel (ATP) III Guidelines, updated in NHLBI collaborated with ACC/AHA/TOS to publish 4 separate guidelines for the prevention of ASCVD Assessment of Cardiovascular Risk Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults Lifestyle Management to Reduce Cardiovascular Risk Management of Overweight and Obesity in Adults Evolution of Lipid Guidelines

7 Recommendations limited to RCT evidence Identification of four statin benefit groups New perspective on treatment goals: intensity of therapy rather than LDL-C or non-hdl cholesterol treatment targets Global risk assessment for primary prevention Role of biomarkers and non-invasive tests Engage in a clinician-patient discussion before initiating statin therapy, especially for primary prevention. No recommendations for non-statin therapy (IMPROVE-IT, November 2014) Significant Changes

8 Individuals with clinical ASCVD (and coronary artery disease risk equivalents) Individuals with primary elevations of LDL-C>190 mg/dl Individuals years of age with diabetes with LDL-C mg/dl Individuals without clinical ASCVD who are years of age with LDL-C mg/dl and an estimated 10-year ASCVD risk of 7.5% or higher xample Statin Benefit Groups

9 Inhibit cholesterol biosynthesis Pleiotropic effects Improve endothelial function Increase nitric oxide bioavailability Enhance the stability of atherosclerotic plaques Decrease oxidative stress and inflammation Inhibit thrombogenic response Cardiovascular Benefits of Statins

10 High-Intensity Moderate-Intensity Low-Intensity Daily dose lowers LDL-C on average by >50% Atorvastatin 40 or 80 mg Rosuvastatin 20 or 40 mg Daily dose lowers LDL-C by approximately 30-<50% Atorvastatin 10 or 20 mg Rosuvastatin 5 or 10 mg Simvastatin 20 or 40 mg Pravastatin 40 0r 80 mg Lovastatin 40 mg Fluvastatin XL 80 mg Fluvastatin 40 mg BID Pitavastatin 2 or 4 mg Daily dose lowers LDL-C on average by <30% Simvastatin 10 mg Pravastatin 10 0r 20 mg Lovastatin 20 mg Fluvastatin mg Pitavastatin 1 mg Intensity of Statin Therapy

11 Pooled Cohort Risk Assessment Gender Age Race (black, caucasian, other) Total cholesterol HDL-C Systolic BP On medication for BP? Diabetes? Smoker? ASCVD Suite Assessing Cardiovascular Risk

12

13

14 This guideline focuses on treatments proven to reduce ASCVD events. It does not, and was never intended to be, a comprehensive approach to lipid management. For the many questions regarding complex lipid disorders that are beyond the scope of our systematic evidence review, or for which little or no RCT data are available, it is anticipated that clinicians with lipid expertise can contribute to their management. ACC/AHA Guideline Limitations

15 1. Potential for ASCVD risk reduction what do statins do? 2. Potential for adverse reactions and drug-drug interactions 3. Heart-healthy lifestyle 4. Management of other risk factors 5. Patient preferences 6. If decision is unclear, consider LDL >160 mg/dl, family history of premature ASCVD, lifetime ASCVD risk, abnormal CAC score or ABI <0.9, or hs-crp >2 mg/l Clinician-Patient Discussion

16 Coronary Calcium Score

17 Ankle Brachial Index

18 Pre-diabetes Metabolic Syndrome Insulin Resistance Auto-Immune Disorders Chronic Kidney Disease Gestational Diabetes or Hypertension Second Generation Antipsychotics HIV History of Hodgkin s Lymphoma Populations at Risk

19 Elevated waist circumference: Men Equal to or greater than 40 inches (102 cm) Women Equal to or greater than 35 inches (88 cm) Elevated triglycerides: Equal to or greater than 150 mg/dl Reduced HDL ( good ) cholesterol: Men Less than 40 mg/dl Women Less than 50 mg/dl Elevated blood pressure: Equal to or greater than 130/85 mm Hg Elevated fasting glucose: Equal to or greater than 100 mg/dl Metabolic Syndrome: at least 3 of 5

20 HDL low* Triglycerides high* Small, dense LDL particles (Pattern B)* LDL may appear to be normal or only slightly elevated-- actual number of LDL particles is high Risk is underestimated *Atherogenic Triad

21 Is pre-diabetes a diabetic risk equivalent?

22 Pre-Diabetes CV Risk

23 NLA RECOMMENDATIONS Opinions on Risk Assessment and Management

24 Atherogenic cholesterol (LDL, non-hdl cholesterol) root cause of atherosclerosis Total cholesterol-hdl=non-hdl cholesterol Reducing atherogenic cholesterol through lifestyle and drug therapies will reduce ASCVD risk in proportion to the degree of reduction LDL and non-hdl are targets of therapy Intensity of risk reduction should be adjusted to patient s absolute risk for an ASCVD event Atherosclerosis begins early in life and is progressive: intermediate and long term risk should be considered when assessing risks and benefits of therapy Statins are primary modality for patients requiring drug therapy for lipid lowering Manage other risk factors appropriately: hypertension, smoking, diabetes NLA Recommendations (Part 1)

25 Risk Category Non-HDL-C* LDL-C ApoB** Low <130 <100 <90 Moderate <130 <100 <90 High <130 <100 <90 Very high <100 <70 <80 *Total cholesterol-hdl=non-hdl cholesterol **ApoB is a secondary optional target of therapy NLA Treatment Goals

26 51 year old female who wants to get healthy Vitals: Ht. 66 ½ inches, Wt. 235 ¼ lbs., BMI 37.4, BP 112/78 RA, 126/74 LA, HR 68, RR 16, WC 50 PMH: HTN, hypothyroidism, hysterectomy & cholecystectomy 2001, hot flashes, mild depression FH: father deceased, had diabetes and heart disease; mother recently died at age 92 of heart disease SH: quit smoking 4 months ago (16 pack year history), married, works from home for an HR department, eats out frequently, goes dancing with husband 1x/week Medications: Synthroid 150 mcg, lisinopril/hctz mg, vitamin D, Prilosec 20 mg daily, Super B complex, progesterone suppository Case Study 1

27 Labs: FLP: total cholesterol 216, triglycerides 120, LDL 127, HDL 65, non-hdl 168 FBS: 114 A1C: 6.3 hs-crp: 8.7 Plan: dietary consult, regular physical activity, weight loss Case Study 1

28 ASCVD or equivalent No Pooled Cohort Equation 1.6% non-dm, 3.1% DM Statin Benefit Group? Maybe Metabolic Syndrome? Yes Other considerations? Hs-CRP 8.7 Non-HDL 168 mg/dl Plan TLC, follow-up 6 weeks Assessment Plan 1

29 Vital signs: BP 124/84, HR 72, Wt. 233, BMI 37.04, WC 49 Repeat labs: FLP: total cholesterol 189, triglycerides 226, LDL 96, HDL 48, non-hdl 141 FBS: 84 A1C: 6.6 hs-crp: 8.0 Plan: continue lifestyle therapies, Crestor 10 mg, metformin Case Study 1

30 71 year old female with long-standing history of dyslipidemia, concerned about cholesterol but prefers natural therapies would consider statin if necessary, paleo diet avoids processed foods, regular physical activity, wants to know particle size Vitals: BP 138/82, HR 64, BMI PMH: osteopenia, migraines FH: father died at 80 years of lung cancer, mom died of cancer at 40; 3 children 2 with dyslipidemia 1 had stroke at age 30 SH: married, retired, never smoker Case Study 2

31 Medications: none Labs: TC 317 LDL 181 HDL 119 triglycerides 86 non-hdl 198 TSH BS 88 egfr >60 Case Study 2

32 ASCVD or equivalent? No Pooled Cohort Equation 12.5% Statin Benefit Group? Metabolic Syndrome? Other considerations? Yes No Non-HDL 198 Plan Patient preference Advanced lipoprotein analysis, CAC, hs-crp Assessment Plan 2

33 Return for review of lab and diagnostics Advanced lipoprotein analysis: particle number high (1807), LDL 196, HDL 116, large pattern A, insulin sensitive, hs-crp 1.5, Lp(a) 22 (normal) CAC=0 Plan: continue with regular physical activity, recommend Mediterranean diet Case Study 2

34 66 year old statin-intolerant female who is concerned about her cholesterol, myalgias from atorvastatin and rosuvastatin Vitals: Ht. 62, Wt. 142, BMI 25.97, BP 124/68, HR 76 PMH: dyslipidemia, GERD, vitamin D deficiency, osteoarthritis, TIA-like symptoms one year ago (slow speech, shaking of left leg) work-up negative FH: father died at 57 of MS; mother died at 80 of lung cancer, had dyslipidemia, one son with type 2 DM SH: has never smoked, regular exercise, married, retired; generally heart healthy diet Medications: omeprazole Case Study 3

35 Labs: Total cholesterol 231 LDL-C 141 HDL-C 72 Triglycerides 90 TSH 1.23 A 1 C 5.5 Case Study 3

36 ASCVD or equivalent? Pooled Cohort Equation Statin Benefit Group? Metabolic Syndrome? Other considerations? No 5.7% 10 year risk No No TIA? Non-HDL 130 Plan hs-crp, CAC, Livalo 2 mg every other day Assessment Plan 3

37 Hs-CRP: 3.5% CAC: Agatston score of only 1.1 and is confined to a very small area of focal calcification in proximal LAD Repeat FLP:TC 224, HDL 70, LDL 118, trigs 178, non- HDL 154 Ultrasound reviewed: mild placquing Plan: Livalo daily, intensify TLC, recheck in 8 weeks add second agent or increase dose if LDL still greater than 100 or non-hdl >130 Case Study 3

38 57 year old Caucasian female presents for routine appointment to establish care. Describes herself as pre-diabetic. Vitals: BP 132/80, HR 82, Wt kg, BMI PMH: hypertension, OA-hips and knees, GERD, dyslipidemia, hyperglycemia, post-menopausal FH: father died at 72 of CAD, CKD; mother has dietcontrolled Type II DM; 1 brother with Type I DM, 1 brother with Type II DM SH: married, 2 grown children, never smoker, no ETOH, works as a nurse Medications: omeprazole, triamterene-hctz 37.5/25, KCl 20 meq, ibuprofen Case Study 4

39 Labs: TC 173, LDL 84, HDL 46, triglycerides 186; BS 186 A1C 5 months ago: 6.8 (6.6, 6.9, 6.6) Case Study 4

40 ASCVD or equivalent? Pooled Cohort Equation Statin Benefit Group? Metabolic Syndrome? Other considerations? Yes, diabetes 3.4% vs. SBG Yes Yes Non-HDL 127 Plan Diabetic education, exercise prescription, Atorvastatin 20 mg, glucophage XR 500 mg daily, recheck 6 weeks; consider ACE/ARB Assessment Plan 4

41 49 year old male presents because he needs prescription refills. History of CAD. 3-vessel CABG in Inferolateral STEMI 2011 with placement of BMS. Anginal symptoms stable notices if he doesn t take second dose of beta blocker, otherwise asymptomatic. Doesn t think he s taken his statin in the past year. Vital signs: BP 100/70, HR 76, RR 14; Wt. 156, BMI PMH: CAD, HTN, dyslipidemia, tubular adenoma sigmoid colon FH: Father and 2 uncles died of heart disease in their early 50 s; one sister with premature heart disease (dyslipidemia, HTN) Case Study 5

42 SH: works as a church administrator, single, never smoked, exercises 1-3 days per week, mostly vegetarian diet Medications: ASA 81 mg, metoprolol tartrate 25 mg BID, ramipril 10 mg daily, previously on Crestor 20 mg Labs: TC 258, HDL 32, triglycerides, LDL 213, glucose 71, K+ 5.2 otherwise electrolytes WNL, egfr >60 Case Study 5

43 ASCVD or equivalent? Pooled Cohort Equation Statin Benefit Group? Metabolic Syndrome? Other considerations? Yes N/A Yes No Non-HDL 226 Plan Resume Crestor at 40 mg daily, review importance of adherence Assessment Plan 5

44 ON THE HORIZON

45 lomitapide (Juxtapid): a microsomal triglyceride transfer protein (MTP) inhibitor mipomersen (Kynamro): an oligonucleotide inhibitor of apo B-100 synthesis that reduces LDL cholesterol by preventing the formation of atherogenic lipids Novel Agents for Homozygous FH

46 Evolocumab Alirocumab Bococizumab PCSK9 Inhibitors in Clinical Trials

47 The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. REMs

48 Apheresis

49 Minnesota Community Measurement

50 Minnesota Community Measurement

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