CVD Risk Assessment. Lipid Management in Women: Lessons Learned. Conflict of Interest Disclosure

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1 Lipid Management in Women: Lessons Learned Conflict of Interest Disclosure Emma A. Meagher, MD has no conflicts to disclose Emma A. Meagher, MD Associate Professor, Medicine and Pharmacology University of Pennsylvania Annual number of adults having diagnosed MI or fatal CHD by age and gender Annual CVD Deaths in Women: Progress has Been Made United States: Deaths, thousands Females Males Roger VL. Circulation 11; 123:18-9 Years Roger VL et al. Circulation. 11 Feb 1; 123(4) Work still needs to be done Women Have a Worse Prognosis Than Men 38% of women will die within 1 year after having a first MI, compared with % for men 64% of women who died suddenly of CHD had no previous symptoms of this disease, compared with 0% for men Risk modification makes a difference, yet risk management in women is poorly implemented CVD Risk Assessment The decision to treat modifiable risk factors is dependent upon the patients CV risk profile Framingham Heart Study, National Heart Lung Blood Institute. American Heart Association. 11 update; Mosca L, et al. Circulation. 11;123:

2 High risk Classification of CVD Risk in Women Moderate (>1 major risk factors) Ideal CV health have all Established CHD Cerebrovascular disease/ PAD / AAA Diabetes mellitus Lloyd Jones DM et al. Circulation. 10;121: End-stage or chronic kidney disease Cigarette smoking / poor diet / physical inactivity Obesity, especially central adiposity FHx premature CVD (< y in male,< 6 y in female) Hypertension (SBP>1, DBP>80 mmhg or on Tx) Dyslipidemia (TC >0, HDL <0 or on treatment) Evidence of subclinical vascular disease Metabolic syndrome Poor exercise capacity on treadmill test Total Cholesterol <0mg/dl untreated Fasting Blood sugar <mg/dl untreated BMI<2 No smoking, Physically active (10 mins/wk), Healthy diet (DASH Like) Estimated 10-Year CHD Risk in -Year-Old Adult Women According to Levels of Various Risk Factors Framingham Heart Study Estimated 10-Year Rate (%) Blood Pressure (mm Hg) 1/80 140/ 140/ 140/ Total Cholesterol (mg/dl) HDL Cholesterol (mg/dl) Diabetes No No Yes Yes Cigarettes No No No Yes Wilson PWF, et al. Circulation. 1998;97: A B C D Atherosclerotic Plaque Development Prevention is critical Priorities for Prevention for High-risk Women Class I recommendations Smoking cessation Physical activity/cardiac rehabilitation Diet therapy Weight maintenance/reduction Blood pressure control Lipid management Aspirin therapy -Blocker therapy ACE inhibitor therapy (ARBs if contraindicated) Glycemic control in diabetics Mosca L, et al. Circulation. 11;123: Dyslipidemia Is Prevalent Among Women Percent of Women With Elevated Blood Cholesterol Levels Percent of population Total cholesterol >0 mg/dl 44 LDL cholesterol > 130 mg/dl 1 HDL cholesterol <40 mg/dl NCEP ATPIII identifies an HDL-C level <0 mg/dl as abnormal for women as part of the diagnosis for the metabolic syndrome. American Heart Association. 04 Heart and Stroke Statistical Update. Dallas, Texas: AHA, 03. Age-adjusted Cardiovascular Disease Mortality in Women by LDL-C and HDL-C (LRC Study) Cardiovascular Disease Mortality per 0 Person-Years At all levels of LDL-C, CVD mortality rates in women with low HDL-C levels were 3 to 4 times greater compared with women with high HDL-C levels Bass KM et al. Arch Intern Med 1993;13: HDL-C <0 mg/dl HDL-C >0 mg/dl < 130 mg/dl mg/dl 160 mg/dl LDL-Cholesterol 2

3 Coronary Heart Disease in Relation to HDL-C and Triglyceride Levels in Women Framingham Heart Study National Heart, Lung, and Blood Institute Optimal lipid levels Total Cholesterol <0 mg/dl Women LDL-C < mg/dl CHD/0/10 yr HDL-C >0 mg/dl TG <10 mg/dl HDL Cholesterol (mg/dl) Participants aged 49 to 82 years who were followed for 12 years. Castelli WP. Can J Cardiol. 1988;4:A-10A. Non HDL-C 130mg/dL Lloyd Jones DM et al. Circulation. 10;121: Adapted from: Mosca L, et al. Circulation. 04;109: Improvement in Managing Cholesterol, But Highest Risk Patients Still Lag Behind Good News % TC < 180 mg/dl % at ATP III LDL-C goal Bad News 12% no Rx post MI, CABG, PCI 1 1/3rd high risk pts had an LDL-C > (mean LDL-C 127) 2 Highest risk pts: Only 30% had LDL-C < 70 mg/dl 2 CABP= coronary artery bypass graft PCI= Percutaneous Coronary Intervention TC=Total Cholesterol 1. Kotseva K, Lancet 09;373: Waters D, Circulation 09;1: % of level at -6 months before menopause % of level at -6 months before menopause Total Cholesterol Lipids are a moving target: Change in Perimenopause LDL-C Jensen J et al. Maturitas 19;12: HDL-C Triglycerides ATP (Adult Treatment Panel)III Update: Guidance for Treatment of Dyslipidemia CVD Risk Reduction Intervention Risk Category Very High risk: ACS, CHD w/dm, mult CRF LDL-C Goal Initiate TLC at LDL of Consider Drug Therapy <70 mg/dl 70 mg/dl 70 mg/dl Lipid Management High risk: CHD or CHD risk equivalents < mg/dl (optional goal: <70 mg/dl) mg/dl > mg/dl (< mg/dl: consider drug option) Moderate risk: 2+ risk factors <130 mg/dl (optional goal: < mg/dl) 130 mg/dl 160 mg/dl (>130 mg/dl: consider drug option) Adapted from Grundy, S. et al., Circulation. 04;:

4 Non-pharmacologic Measures Specific Dietary Intake Recommendations for Women Dietary Interventions specific to lipid management Saturated fat <7% of calories <0mg/d of dietary cholesterol Plant stanol esters Physical Activity 10mins/wk of moderate activity or 7 mins of intense activity /wk Weight Reduction Mosca L et al. Circulation. 11;123: , Grundy, S. et al., Circulation. 04;: Mosca L et al. Circulation. 11;123: Impact of TLC on Lipid Profiles A HDL Cholesterol B Triglycerides C LDL Cholesterol D Ratio of Total Cholesterol to HDL Cholesterol Low-fat diet Mediterranean diet Low-carbohydrate diet Changes in biomarkers during maximum weight-loss phase (1-6 mos) and weight-loss maintenance phase (7-24 mos) Shai I, et al. N Engl J Med. 08;39: TLC=therapeutic lifestyle changes Pharmacologic Approaches Used in the Treatment of Lipid Disorders Reduce LDL-C HMG CoA reductase inhibitors (statins) Cholesterol absorption inhibtors (CAI; ezetimibe) Bile acid sequestrants (BAS; resins) Niacin Treat TG-HDL axis Fibric acid derivatives (fibrates) Nicotinic acid (niacin) Omega 3 fatty acids (fish oils) Reduction in Major Coronary Events* in Major Statin Trials by Level of Patient Risk Trial N LDL-C Risk Reduction (%) AF/ TexCAPS % Primary WOSCOPS 69 26% CARDS % ASCOT 10,30 28% High Risk HPS,36 29% 4S % װ Secondary LIPID 14 2% CARE % 2 2 *Major coronary events defined as follows: AF/TexCAPS fatal or nonfatal myocardial infarction (MI), unstable angina, sudden cardiac death; WOSCOPS, ASCOT, HPS, LIPID, CARE nonfatal MI or coronary death; 4S-coronary death, nonfatal MI, silent MI, resuscitated cardiac arrest. P<.001; P=.001; P=.000; װ P<.0001; P=.002. LaRosa J et al. JAMA. 1999;282: ; HPS Collaborative Group. Lancet. 02;360:7-22; Sever PS et al. Lancet. 03;361: ; Colhoun H et al. Lancet. 04;364: Intensive Statin Therapy Reduced CV Events in Primary Prevention: JUPITER Cumulative Incidence Primary Endpoint: MI, Stroke, UA/Revascularization, CV Death HR 0.6, 9% CI P< Achieved LDL-C (mg/dl) Placebo 109 Rosuvastatin Placebo 21 / % Rosuvastatin 142 / Number at Risk Follow-up (years) Rosuvastatin 8,1 8,631 8,412 6,40 3,893 1,98 1, Placebo 8,1 8,621 8,33 6,08 3,872 1,963 1, Ridker PM, et al. N Engl J Med. 08;39(21):

5 Efficacy of High-Dose Statins: Composite Primary Endpoints Statin therapy in Women : what s the evidence it works Risk Reduction (%) Meta -analysis of 18 primary prevention trials showed CV event rates and all cause mortality were lowered to similar degrees in both genders Jupiter enrolled ~7000 females showed a benefit * Acute Coronary Syndrome Chronic Stable Disease *High-dose atorvastatin vs usual-dose pravastatin; Simvastatin; Atorvastatin; High-dose atorvastatin vs usual-dose simvastatin. Ray KK et al. J Am Coll Cardiol. 0;46: ; de Lemos JA et al. JAMA. 04;292: ; La Rosa JC et al. N Engl J Med. 0;32: ; Pedersen TR et al. JAMA. 0;294: The Mega Study showed usefulness of pravastatin in primary prevention of CV events in women. Kostis WJ. J Am Coll Cardiol 12;9: Mizuno K. Circulation 08:I17: Mora S, Circulation 10;121: Risk of Type II Diabetes Statin therapy in Women : What s the evidence that it is safe? Jupiter and AFCAPs/TexCAPS relative risk of developing diabetes of 1.18 (9% CI 1.01 to 1.39). Meta analysis of 13 trials RR of 1.09 (9% CI ) NNH = treat 22 people for 4 y to cause 1 new case of DM Sattar N. Lancet 10;37: Taylor F. Cochrane Database of Syst Rev 11: CTT Metanalysis Death, Cancer,06 patients in 14 statin trials Treatment Control Hazard Ratio (9% CI) # Patients 4,04 4,002 New cancers (6.4%) (6.4%) (0.9, 1.06) Death (8.%) (9.7%) (0.84, 0.91) Ca. deaths (2.4%) (2.4%) (0.91, 1.12) Is Lowering LDL-C Enough? Despite on-therapy LDL-C <80 mg/dl, a significant number of patients on statin monotherapy still have events 1,2 Despite LDL-C lowering, residual risk remains high for at least 2 years following the index event, with about two thirds of CHD events not avoided 1 Baigent C et al. Lancet. 0;366: Cannon CP et al. N Engl J Med. 04;30: ; 2. de Lemos JA et al. JAMA. 04;292: ; 3. LaRosa J et al. JAMA. 1999;282: ; 4. HPS Collaborative Group. Lancet. 02;360:7-22.

6 Intensive Statin Therapy Following ACS Reduces Recurrent Events: PROVE-IT 40 mg of pravastatin On Treatment Levels of Lipid Parameters and Risk of Cardiovascular Events TNT and IDEAL Residual Risk 80 mg of atorvastatin P=.00 Lipid Parameter Hazard Ratio* 9% CI LDL cholesterol Non-HDL cholesterol Apolipoprotein B Total/HDL cholesterol LDL/HDL cholesterol Apolipoprotein B/A-I of Follow-up Cannon CP, et al. N Engl J Med. 04;30: *Calculated by a Cox proportional hazard model with adjustment for the effects of study, age, sex. Calculated as total cholesterol minus HDL cholesterol. Kastelein JJ, et al. Circulation. 08;117: Non-HDL Cholesterol as the Second Goal of Therapy: NCEP ATP III LDL-C lowering is the primary goal of lipid lowering therapy When Triglycerides are 0 mg/dl, non HDL-C is a secondary target of therapy, with a goal 30 mg/dl higher than the identified LDL-C goal When Triglycerides are > 00: non-hdl-c is a primary target Adult Treatment Panel III of the National Cholesterol Education Program. JAMA. 01;28: Grundy, S. et al., Circulation. 04;: What do we do about residual risk: a role for combination therapy? Statins + niacin Aim High showed no benefit 12 HPS2 thrive - 13 Statins + fibrates ACCORD showed no benefit - 10 Statins + bile acid sequestrants not studied Statins + ezetimibe no benefit so far Ezetimibe + fibrate not studied Statins + omega-3 fatty acids JELIS: Statin + Fish Oil Combination Therapy Conclusions CVD remains the leading cause of death in the United States Rate of Events (%) Traditional risk factors, such as dyslipidemia, explain the majority of the risk for CV events in women TLC form the basis of all treatment strategies in women Statin therapy is the best studied approach for the treatment of dyslipidemia in women and is effective and relatively safe MACE* Unstable Angina Non-HDL and HDL are sensitive predictors of CV events but thus far pharmacologic therapy treatment aimed at improving these parameters has shown definitive success *Primary endpoint; P=.011; P=.014 JELIS = Japan EPA Lipid Intervention Study; MACE = major adverse coronary events. Beller GH, Yokoyama M. Poster presented at: American Heart Association Scientific Session; Dallas Texas; November 13-16, 0. For those who do not tolerate statins, other agents alone or in combination offer novel therapeutic approaches 6

7 Back up Lipid and lipoprotein levels and lifestyle and Lipids Lipid and lipoprotein levels: optimal levels and lifestyle The following levels of lipids and lipoproteins in women should be encouraged through lifestyle approaches: LDL-C mg/dl, HDL-C 0 mg/dl, triglycerides 10 mg/dl, and non HDL-C (total cholesterol minus HDL) 130 mg/dl (Class I; Level of Evidence B). Lipids: pharmacotherapy for LDL-C lowering, high-risk women LDL-C lowering drug therapy is recommended simultaneously with lifestyle therapy in women with CHD to achieve an LDL-C mg/dl (Class I; Level of Evidence A) and is also indicated in women with other atherosclerotic CVD or diabetes mellitus or 10-year absolute risk % (Class I; Level of Evidence B). A reduction to 70 mg/dl is reasonable in very-high-risk women (eg, those with recent ACS or multiple poorly controlled cardiovascular risk factors) with CHD and may require an LDL-lowering drug combination (Class IIa; Level of Evidence B). Continued Lipids: pharmacotherapy for LDL-C lowering, other at-risk women LDL-C lowering with lifestyle therapy is useful if LDL-C level is 130 mg/dl, there are multiple risk factors, and the 10-y absolute CHD risk is 10% to % ((Class I; Level of Evidence B). LDL-C lowering is useful with lifestyle therapy if LDL-C level is 160 mg/dl and multiple risk factors even if 10-y absolute CHD risk is 10% (Class I; Level of Evidence B). LDL-C lowering with lifestyle therapy is useful if LDL 1 mg/dl regardless of the presence or absence of other risk factors or CVD (Class I; Level of Evidence B). In women 60 y of age and with an estimated CHD risk 10%, statins could be considered if hscrp is 2 mg/dl after lifestyle modification and no acute inflammatory process is present (Class IIb; Level of Evidence B). Continued Lipids: pharmacotherapy for low HDL-C or elevated non HDL-C Niacin or fibrate therapy can be useful when HDL-C is low (0 mg/dl) or non HDL-C is elevated (130 mg/dl) in high-risk women after LDL-C goal is reached (Class IIb; Level of Evidence B). Diabetes mellitus Lifestyle and pharmacotherapy can be useful in women with diabetes mellitus to achieve an HbA1C 7% if this can be accomplished without significant hypoglycemia (Class IIa; Level of Evidence B). Mosca L et al. Circulation. 11;123:

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