Treating Lipids for Prevention of CAD in Women: Matching Therapy to Risk

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1 TREATING LIPIDS FOR PREVENTION OF CAD IN WOMEN: MATCHING THERAPY TO RISK Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Declaration of full disclosure: No conflict of interest EXPLAINING THE DECREASE IN DEATHS FROM CHD 1980 to 2000: Death rate fell from: to per 100K men to per 100K women 341,745 fewer deaths from CHD in 2000 Ford ES, NEJM, 2007 EXPLAINING THE DECREASE IN DEATHS FROM CHD A RISK-BASED APPROACH 47% from CHD treatments, 44% from risk factor modification Risk reduction $$ Harm Reductions in cholesterol: 24% Ford ES, NEJM, 2007 The benefit from any given intervention is a function of: 1) The relative risk reduction conferred by the intervention, and 2) The native risk of the patient 1

2 63 yo woman; s/p MI LDL 115 HDL 45 TG Begin a statin to goal LDL Begin a statin to goal LDL Begin a statin plus ezetimibe to LDL goal 70 LDL Goal and Cutpoints in Patients with CHD and CHD Risk Equivalents (10-Year Risk >20%) 2004 LDL Goal <100 mg/dl Optional : <70 LDL Level at Which to Initiate Diet 100 mg/dl LDL Level at Which to Consider Drug Therapy 100 mg/dl (<100mg/dL: drug optional) Baseline Feature LDL (mg/dl) < < ALL PATIENTS Heart Protection Study: Vascular Events by Baseline LDL-C No. Events Statin Placebo (10,269) (10,267) (19.9%) (25.4%) Risk Ratio and 95% Cl Statin better Statin worse 24% reduction (p< )

3 TREATING TO NEW TARGETS (TNT) RCT of 10,001 patients with stable CHD; yr LDL <130 mg/dl Atorvastatin 10 vs atorvastain 80 Followed for 4.9 years Research question: safety and efficacy of lowering LDL below 100 mg/dl TREATING TO NEW TARGETS (TNT) LDL Event % Death % LFTs % Atorv Atorv p value < Larosa NEJM, 2005 High Dose Statins Not a Free Shot High-dose atorvastatin after stroke or TIA SPARCL Trial 4731 post-stroke/tia pt s atorvastatin 80 vs placebo Recurrent stroke: 265 vs. 311 (RR 0.84) Ischemic stroke: 218 vs. 274 (RR 0.78) Hemorrhagic stroke: 55 vs. 33 (RR 1.66) Death: 216 vs. 211 (RR 1.00) Antithrombotic effect from statins? Consistent with observational data (low cholesterol) 2. Begin a statin to goal LDL Begin a statin to goal LDL Begin a statin plus ezetimibe to LDL goal 70 NEJM 2006;355(6):

4 63 yo woman; diabetes LDL 115 HDL 45 TG Begin a statin 3. Begin fenofibrate 4. Begin a statin plus ezetimibe Baseline Feature HPS: Vascular Events by Prior Disease No. Events Statin Placebo (10,269) (10,267) Risk Ratio and 95% Cl Statin better Statin worse COLLABORATIVE ATORVASTATIN DIABETES STUDY (CARDS) RCT of 2838 patients, 40-70, with DM2 + HTN, cigs, or diabetic complication Previous MI Other CHD No prior CHD CVD PVD Diabetes ALL PATIENTS (19.9%) (25.4%) % reduction (p< ) LDL 117 mg/dl Atorvastatin 10 vs placebo Followed for 4 years Research question: is statin better than placebo for primary prevention in patients with diabetes? Colhoun, Lancet

5 COLLABORATIVE ATORVASTATIN DIABETES STUDY (CARDS) Trial terminated two years early Placebo 127 events vs. atorvastain 83 Reduction 37% all events Reduction in CHD (36%), revascularizations (31%), stroke (48%), death (27%) FENOFIBRATE INTERVENTION AND EVENT LOWERING IN DIABETES (FIELD) STUDY RCT of 9795 patients, 50-75, with DM2 Fenofibrate 200 vs placebo Followed for 5 years Outcome: coronary events Keech, Lancet 2005 FENOFIBRATE INTERVENTION AND EVENT LOWERING IN DIABETES (FIELD) STUDY Coronary events: 5.9% on placebo vs. 5.2% on fenofibrate 11% reduction, not statistically significant HR 0.89 (95% CI ) p= Begin a statin 3. Begin fenofibrate 4. Begin a statin plus ezetimibe 5

6 CHD Risk Equivalents Risk for major coronary events equal to that in established CHD e.g. >20%risk of MI or CHD death in 10 years Peripheral artery disease Abdominal aortic aneurysm Symptomatic CVD Diabetes Multiple risk factors with >20% risk in 10 years Other Potential CHD Risk Equivalents Risk for major coronary events equal to that in established CHD e.g. >20%risk of MI or CHD death in 10 years Renal insufficiency: probably yes Congestive heart failure: probably not Metabolic syndrome: probably not (calculate Framingham risk) Kjekshus, NEJM yo woman; s/p MI LDL 70 HDL 25 TG Begin a statin 3. Begin fenofibrate 4. Begin fish oil 6

7 63 yo woman; s/p MI {LDL 70, HDL 25, TG 400, Total 175} Total - HDL = Non-HDL = 150 NCEP non-hdl goal: LDL goal + 30 = 100 Risk of CHD Low HDL-C is an Independent Predictor of CHD Risk Even When LDL-C is Low LDL-C (mg/dl) Gordon T et al. Am J Med 1977;62: HDL-C (mg/dl) HDL AS A THRAPEUTIC TARGET Systematic review of 31 RCTs Currently available therapies (drug and non-drug) can increase by 20-30% proof that increasing HDL confers reduction in CV outcomes independent of changes in LDL or TG changes has been elusive. Conclusion: only modest evidence to support aggressively increasing HDL beyond lifestyle interventions Management of Low HDL-C Therapeutic lifestyle changes Smoking cessation Regular aerobic exercise Weight loss Alcohol use? Singh, JAMA

8 CETP INHIBITORS TO INCREASE HDL Inhibition of cholesteryl ester transfer protein markedly raises HDL (and raise BP) Two trials show no benefit on coronary atherosclerosis or carotid intimal medial thickness (compared to atorvastatin alone) Clinical trial of 15,000 stopped prematurely due to excess mortality and events in those on torcetrapib vs. placebo Pfizer abandons development of torcetrapib Nissen, NEJM 2007; Tall, NEJM 2007 VA-HIT: Major Coronary Events in Gemfibrozil vs. Placebo Groups Cumulative Incidence (%) 0 22% reduction P = Placebo Year Rubins HB et al. N Engl J Med 1999;341: Gemfibrozil Combination Drug Therapy Adding Niacin or a Fibrate to a Statin Pros Better TG and HDL-C May LDL-C more (niacin or fenofibrate) Lp(a) (niacin) LDL particle size Fibrinogen (fibrates) Angiographic data Cons Increased cost and complexity Increased myositis risk Increased hepatitis risk (niacin) Potential for other drug interactions Lack of outcome data Management of Low HDL-C Lifestyle changes and secondary causes Pharmacologic therapy If LDL-C elevated: statin If TG elevated: fibrate or fish oil If isolated low HDL-C: niacin Combination therapy 8

9 If, however, primary prevention? 2. Begin a statin 3. Begin fenofibrate 4. Begin fish oil 2. Begin a statin 3. Begin fenofibrate 4. Begin fish oil 63 yo woman, no risk factors LDL 175 HDL 45 TG Begin a statin 3. Begin fenofibrate 4. Begin a stain plus ezetimibe 9

10 POSITIVE RISK FACTORS Age: Men >45: women >55 Family history premature CHD Cigarette smoking Hypertension Low HDL-cholesterol (<40 mg/dl) NEGATIVE RISK FACTOR High HDL-cholesterol > 60 mg/dl LDL Goal and Cutpoints Patients with Risk Factor 2001 and 2004 CALCULATING RISK LDL Goal <160 mg/dl LDL Level at Which to Initiate Diet 160 mg/dl LDL Level at Which to Consider Drug Therapy 190 mg/dl ( mg/dl: LDL-lowering drug optional) Traditional risk factors Increasing age Male gender Hypertension Diabetes Smoking High LDL cholesterol Low HDL cholesterol Family history of CHD NCEP II approach Count risk factors NCEP III approach Count risk factors +/- calculate 10-year risk My recommendation Calculate 10-year risk and discuss with patient 10

11 63 yo woman, no risks LDL 175 HDL 45 TG 160 SBP 120 Nonsmoker NCEP: no treat 10 yr risk: 3% no 2. Begin a statin 3. Begin fenofibrate 4. Begin fish oil 63 yo man, no risk factors LDL 175 HDL 45 TG 160 SBP 120 Nonsmoker NCEP: no treat 10 yr risk: 13% yes (statin and ASA) 2. Begin a statin 3. Begin fenofibrate 4. Begin a stain plus ezetimibe 6. Intensify diet therapy 11

12 Therapeutic Lifestyle Changes (TLC): Major features TLC Diet Reduced intake of cholesterol-raising nutrients Saturated fats <7% of total calories Dietary cholesterol <200 mg per day LDL-lowering therapeutic options Plant stanols/sterols (2 g per day) Soluble fiber (10 25 g per day) TLC for patients with LDL-C = 160 Dietary Component Low saturated fat/dietary cholesterol Viscous fiber (10 25 g/d) LDL-C (mg/dl dl) 12 8 Weight reduction Increased physical activity Plant stanols/sterols (2 g/d) Total mg/dl ATP III, NCEP 2001 EFFECT OF A PLANT-BASED DIET EFFECT OF PLANT-BASED DIET 120 patients, LDL , 4 weeks Low fat vs. low fat plus Equivalent macronutrients Low-fat plus had more vegetables, legumes, whole grains LDL mg/dl Low fat -7.0 Low fat plus Conclusion: current guidelines may underestimate potential LDL-lowering effect Gardner, Ann Intern Med, 2005 Gardner, Ann Intern Med,

13 Cholesterol-Lowering Foods vs Lovastatin 46 volunteers with hyperlipidemia, 1 month study, foods provided Randomized to control diet vs control diet and lovastatin vs dietary portfolio Control diet: vegetarian, very low in saturated fat, whole wheat cereals, low fat dairy foods Portfolio diet: also very low saturated fat, vegetarian diet, plus high in plant sterols, soy protein, soluble fibers, almonds DIETARY PORTFOLIO Breakfast: Oat bran cereal, soy beverage, strawberries, sugar and psyllium, oat bran bread, enriched margarine (with sterols), fruit jam Snack: Almonds, soy beverage, fresh fruit Lunch: Black bean soup, sandwich (soy deli slices, oat bran bread, enriched margarine, lettuce, tomato, cucumber) Snack: Almonds, psyllium, fresh fruit Dinner: Tofu bake with ratatouille (tofu, eggplant, onions, peppers) Jenkins, Am J Clin Nutr, 2005 Snack: Fresh fruit, psyllium, soy beverage Jenkins, Am J Clin Nutr, 2005 Cholesterol-Lowering Foods vs Lovastatin LDL CRP Control -8.0% -10.0% Control/statin -30.9% -33.3% Portfolio -28.6% -28.2% 63 year old woman, HTN LDL 175 HDL 45 TG 160 SBP 120 on RX Nonsmoker Jenkins, Am J Clin Nutr,

14 LDL Goal and Cutpoints Patients with Multiple Risk Factors (10-Year Risk 20%) 2004 LDL Goal <130 mg/dl LDL Level at Which to Initiate Diet 130 mg/dl LDL Level at Which to Consider Drug Therapy 10-year risk 10 20%: 130 Optional year risk <10%: yo woman, HTN LDL 175 HDL 45 TG 160 SBP 120 on RX Nonsmoker NCEP: yes 10 yr risk: 6% maybe not 63 yo man, HTN LDL 175 HDL 45 TG 160 SBP 120 on RX Nonsmoker NCEP: yes 10 yr risk: 18% yes PRIMARY PREVENTION OF CVD WITH STATINS Meta-analysis of 7 trials and 42,848 patients, 4.3 years Coronary events -29.2%.001 Cerebrovascular events -14.4%.02 Revascularizations -33.8%.001 CHD mortality -22.6%.13 Overall mortality - 8%.09 No increased cancer, LFTs or CKs Thavendiranathan, Arch Int Med

15 LONG-TERM FOLLOW-UP OF WEST OF SCOTLAND STUDY TOTAL 15 YEAR FOLLOW-UP: NNT Death from CHD or MI: 15.5% vs. 11.8% (p<0.001) NNT 27 per 15 years; 405 per year All cardiovascular mortality: 9.0 vs. 7.6 (p=.01) NNT 71 per 15 years; 1065 per year All cause mortality: 20.5 vs 18.7 (p=0.03) NNT 55 per 15 years; 825 per year EMERGING RISK FACTORS Lipoprotein (a) Small Dense LDL Homocysteine Fibrinogen Inflammatory factors Subclinical atherosclerosis Ford, NEJM 2007 EMERGING RISK FACTORS Evidence review of CRP, Lp(a), fibrinogen, homocysteine All independently associated with CVD Little evidence of additional yield over Framingham risk factors Less evidence on use in guiding treatment Explanatory power of established risk factors underestimated C-reactive protein (CRP) Hard to directly integrate into the Framingham risk. Rough calculations: CRP in top third increases risk by factor of Average risk = x Risk in top tertile = 1.3x Risk in middle tertile = x Risk in middle tertile = 0.7x 15

16 CONCLUSIONS Patients with CHD or CHD equivalent: Treat aggressively with statin independent of LDL level (to LDL <70 in most cases) Treat other risk factors aggressively as well, especially easy ones (HTN, Aspirin use) Treat elevated non-hdl cholesterol and low HDL Patients at high risk are undertreated CONCLUSIONS Patients without CHD: Assess overall risk with Framingham risk score LDL goal LDL treatment threshold High Risk (>20%) <100 (<70 optional) 100 (<100 optional) Mod high risk (10-20%) < ( optional) Moderate risk (5-10%) < Lower risk (<5%) < ( optional) Engage patient in shared decision making, especially if risk <10% 16

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