JUPITER NEJM Poll. Panel Discussion: Literature that Should Have an Impact on our Practice: The JUPITER Study

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1 Panel Discussion: Literature that Should Have an Impact on our Practice: The Study Kaiser COAST 11 th Annual Conference Maui, August 2009 Robert Blumberg, MD, FACC Ralph Brindis, MD, MPH, FACC Primary Objectives Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin To investigate whether rosuvastatin 20 mg compared to placebo would decrease the rate of first major cardiovascular events among apparently healthy men and women with LDL < 130 mg/dl (3.36 mmol/l) who are nonetheless at increased vascular risk on the basis of an enhanced inflammatory response, as determined by hscrp > 2 mg/l. To enroll large numbers of women and individuals of Black or Hispanic ethnicity, groups for whom little data on primary prevention with statin therapy exists. The Trial: Will You Change Your Practice? In patients with hyperlipidemia, treatment with statins reduces cardiovascular risk, even in people without a history of cardiovascular disease. However, nearly half of all first cardiovascular events occur in people whose low-density lipoprotein (LDL) cholesterol levels are below current thresholds for lipid-lowering therapy. Therefore, recent research has sought to refine our ability to identify people who are at risk and to find interventions capable of reducing that risk. NEJM Poll Do you believe, on the basis of the trial results, that the approach to laboratory screening of apparently healthy adults should be changed? Yes, the trial results indicate that the approach to laboratory screening should be changed. 49% No, the trial results do not provide a basis for a change in the approach to laboratory screening. 51% 2553 total responses

2 NEJM Poll Do you believe, on the basis of the trial results, that the therapeutic use of statins in apparently healthy adults should be changed? LDLC Levels in 136,905 Patients Hospitalized With CAD: LDLC (mg/dl) < > 160 Yes, the trial results indicate that the therapeutic use of statins should be changed. 48% No, the trial results do not provide a basis for a change in the therapeutic use of statins. 52% Sachdeva et al, Am Heart J 2009;157:111-7.e2. CTT meta-analysis: Proportional reduction in NON-FATAL MI or CHD DEATH versus absolute LDL-C reduction The Acute-Phase Response Pathway Proportional reduction in coronary event rate (95% CI) 30% 25% 20% 15% 10% 5% 0% A to Z IDEAL SEARCH TNT PROVE-IT More vs less (5 trials) Statin vs control (18 trials) Proinflammatory Risk Factors Primary Proinflammatory Cytokines (eg, IL-1, TNF-a) ICAM-1 Selectins, HSPs, etc. Endothelium and other cells Circulation IL-6 Messenger Cytokine CRP SAA Liver Mean LDL cholesterol difference between treatment groups (mmol/l) Adapted from Libby, Ridker. Circulation ;100:

3 CRP Epidemiology Is C-reactive protein (CRP) a causal factor in the pathogenesis of atherosclerosis? If it is, implications could be far reaching for new approaches for the prevention and treatment of myocardial infarction and stroke. CRP Epidemiology Support for a role of CRP in the pathogenesis of atherosclerosis are from epidemiologic studies that have consistently observed an association between elevated plasma CRP levels and cardiovascular events. CRP: Chicken or the EGG? Why Consider Statins for Low LDL, high hscrp Patients? AFCAPS/TexCAPS Low LDL Subgroups Low Low LDL, LDL, Low LowhsCRP Low Low LDL, LDL, High HighhsCRP hscrp [A] [B] Statin Statin Effective Effective RR Statin Statin Not Not Effective Effective However, while intriguing and of potential public health importance, the observation in AFCAPS/TexCAPS that statin therapy might be effective among those with elevated hscrp but low cholesterol was made on a post hoc basis. Thus, a large-scale randomized trial of statin therapy was needed to directly test this hypotheses. Ridker et al, New Engl J Med 2001;344:

4 Trial Design Multi-National Randomized Double Blind Placebo Controlled Trial of Rosuvastatin in the Prevention of Cardiovascular Events Among Individuals With Low LDL and Elevated hscrp No Prior CVD or DM Men >50, Women >60 LDL <130 mg/dl hscrp >2 mg/l 4-week run-in Ridker et al, NEJM : MI Rosuvastatin 20 mg (N=8901) Stroke Unstable Angina Placebo (N=8901) CVD Death CABG/PTCA Baseline LDLC Baseline HDLC Baseline hscrp 104 mg/dl 49 mg/dl 4.2 mg/l Women 6,800 Non-Caucasian 5,000 Baseline Clinical Characteristics Rosuvastatin Placebo (N = 8901) (n = 8901) Age, years (IQR) 66.0 ( ) 66.0 ( ) Female, N (%) 3,426 (38.5) 3,375 (37.9) Ethnicity, N (%) Caucasian 6,358 (71.4) 6,325 (71.1) Black 1,100 (12.4) 1,124 (12.6) Hispanic 1,121 (12.6) 1,140 (12.8) Blood pressure, mm (IQR) Systolic 134 ( ) 134 ( ) Diastolic 80 (75-87) 80 (75-87) Smoker, N (%) 1,400 (15.7) 1,420 (16.0) Family History, N (%) 997 (11.2) 1,048 (11.8) Metabolic Syndrome, N (%) 3,652 (41.0) 3,723 (41.8) Aspirin Use, N (%) 1,481 (16.6) 1,477 (16.6) All values are median (interquartile range) or N (%) Baseline Blood Levels (median, interquartile range) Effects of rosuvastatin 20 mg on LDL, HDL, TG, and hscrp Rosuvastatin Placebo (N = 8901) (n = 8901) hscrp, mg/l 4.2 ( ) 4.3 ( ) LDL, mg/dl 108 (94-119) 108 (94-119) HDL, mg/dl 49 (40 60) 49 (40 60) Triglycerides, mg/l 118 (85-169) 118 (86-169) 50% 12-months LDL reduction 4% 12-months HDL increase Total Cholesterol, mg/dl 186 ( ) 185 ( ) Glucose, mg/dl 94 (87 102) 94 (88 102) HbA1c, % 5.7 ( ) 5.7 ( ) All values are median (interquartile range). [ Mean LDL = 104 mg/dl ] 37% 12-months hs CRP 37% reduction Months 17% 12-months TG 17% reduction Months

5 - Primary Endpoint Time to first occurrence of a CV death, non-fatal stroke, non-fatalmi, unstable angina or arterial revascularization Cumulative Incidence Hazard Ratio 0.56 (95% CI ) P< Placebo - 44 % Rosuvastatin 20 mg NNT for 2y = 95 5y* = Number at Risk Follow-up (years) Rosuvastatin 8,901 8,631 8,412 6,540 3,893 1,958 1, Placebo 8,901 8,621 8,353 6,508 3,872 1,963 1, *Extrapolated figure based on Altman and Andersen method Ridker P et al. N Eng J Med 2008;359: Predicted Benefit Based on LDL Reduction vs Observed Benefit Proportional reduction in vascular event rate (95% CI) A-to-Z TNT IDEAL CTT PROVE-IT Mean LDL cholesterol difference between treatment groups (mmol/l) PREDICTED Predicted Benefit Based on LDL Reduction vs Observed Benefit Primary Endpoint Subgroup Analysis II 55 N P for Interaction Proportional reduction in vascular event rate (95% CI) A-to-Z TNT IDEAL Mean LDL cholesterol difference between treatment groups (mmol/l) CTT PROVE-IT OBSERVED PREDICTED Family HX of CHD No Family HX of CHD BMI < 25 kg/m 2 2 BMI kg/m 2 BMI >30 kg/m Metabolic Syndrome No Metabolic Syndrome Framingham Risk < 10% Framingham Risk > 10% hscrp > 2 mg/l Only All Participants 2, ,684 4,073 37% 0.70 PCR reduction 7,009 6,675 hscrp > 2 mg/l Only 6,375 REVERSAL 7, ,296 8, ,895 6,375 17,802 in. Same magnitude in Rosuvastatin Superior Rosuvastatin Inferior

6 . Primary End Point NNT (1 event): 120 patients treated for 1.9 years Ridker P et al. N Eng J Med 2008;359: Primary Prevention with Statins : Caveats Benefits vs Adverse Events NNH=166. That means: More than a new-onset diabetes vs 2 prevented events Primary Prevention with Statins : Caveats. Study Stopped Earlier than planned Lipids an IHD Secondary Prevention Y=0,1629x-4,6776 R 2 =0,9029 P<0,0001 4S-P Overestimate the beneficial effects MACE (%) 20 HPS-S 4S-S LIPID-P 15 HPS-S CARE-P LIPID-S 10 PROVE-IT- CARE-S AT SPARCL-P PROVE-IT 5 PR SPARCL-A LDL-C (mg/dl) O Keefe, Jr et al J Am Col Cardiol 2004;43:2142-6

7 A Comparative Study of Biomarkers in Acute Coronary Syndrome Results of the SIESTA study Biomarker levels (categorized in thirds) and the occurrence of the 360-day second study endpoint 1 No events 556 (91.1%) Events 54 (8.9%) P Variable (median) 1st third, n (%) 189 (34) 15 (27.8) CRP, mg/l 2nd third, n (%) 188 (33.8) 15 (28.8) rd third, n (%) 179 (32.2) 24 (44.4) Statins in Primary Prevention Estimation of additional number to treat in U.S. with the selection criteria of 1st third, n (%) 154 (34.9) 7 (17.5) NT-ProBNP, ng/l 2nd third, n (%) 147 (33.3) 13 (32.5) rd third, n (%) 140 (31.7) 20 (50) 1st third, n (%) 183 (34.9) 12 (24) Cystatin C, mg/l 2nd third, n (%) 178 (34) 16 (32) rd third, n (%) 163 (31.1) 22 (44) 1st third, n (%) 183 (35) 6 (12) Fibrinogen, mg/dl 2nd third, n (%) 171 (32.7) 18 (36) rd third, n (%) 169 (32.3) 26 (52) 1 Second composite endpoint represents the occurrence of new non-fatal acute myocardial infarction or all-cause death Kaski JC et al. JACC 2009 Circ Cardiovasc Qual Outcomes 2009;2:41-48 Jupiter Study Limitations The study did not include anyone with hscrp < 2.0 mg/l and therefore the trial does not inform whether people with normal, low, or no hscrp values would have also benefited from the robust LDL-C C lowering. So the ultimate value of hscrp for selecting patients for treatment remains unknown. Principal investigator disclosed financial conflicts of interest as a co-inventor on patents that relate to the use of hscrp in the evaluation of patients risk of cardiovascular disease. AstraZeneca, manufacturer of rosuvastatin, sponsored the study.. Clinical Implications: Is justified treat with statins a population () with normal LDL-cholesterol? Subgroups? YES Whom? Based on Global CV Risk Is necesary a population screening? NO Are these results extrapolable to other statins? Possibly NO

8 THE TRIAL A Consensus Statement for KP Health Care Providers from the Dyslipidemia Management Guideline Development Team Our first priority is to initiate statins and ensure adherence among our high risk members with coronary artery disease, diabetes or coronary artery disease risk equivalents. hscrp has no role in these therapy decisions and should not be ordered. FHS: Risk Assessment Tool for Estimating 10- year Risk of Developing Hard CHD (Myocardial Infarction and Coronary Death) Framingham Heart Study to estimate 10-year risk for hard coronary heart disease outcomes (myocardial infarction and coronary death). This tool is designed to estimate risk in adults aged 20 and older who do not have heart disease or diabetes. 1. Age: years 2. Gender: Female Male 3. Total Cholesterol: mg/dl 4. HDL Cholesterol: mg/dl 5. Smoker: No, Yes 6. Systolic Blood Pressure: mm/hg 7. Currently on medication to treat high blood pressure. No, Yes THE TRIAL A Consensus Statement for KP Health Care Providers from the Dyslipidemia Management Guideline Development Team Recommendations Apply ONLY to Patients for Primary Prevention 1. Do not measure hscrp if decision for Rx already made 2. Determine Framingham 10-year risk status. For people at > 20% risk: If baseline LDL-C C is mg/dl initiate simvastatin 40 mg daily. If baseline LDL-C C is > 160 mg/dl initiate simvastatin 80 mg daily. If baseline LDL-C C is < 100 mg/dl, it is optional to measure hscrp in men > 50 years old and women > 60 years old, and if hscrp is > 2 mg/l, to initiate simvastatin 40 mg daily. (not fully EBM) Target LDL-C C is < 100 mg/dl. THE TRIAL A Consensus Statement for KP Health Care Providers from the Dyslipidemia Management Guideline Development Team For people at Framingham 10-20% risk: If baseline LDL-C C is mg/dl, initiate simvastatin 40 mg daily. If baseline LDL-C C is > 220 mg/dl, initiate simvastatin 80 mg daily. If baseline LDL-C C is < 130 mg/dl, it is optional to measure hscrp in men > 50 years old and women > 60 years old, and if hscrp is > 2 mg/l, to initiate simvastatin 40 mg daily. (not fully EBM) Target LDL-C C is < 130 mg/dl.

9 THE TRIAL A Consensus Statement for KP Health Care Providers from the Dyslipidemia Management Guideline Development Team For people at <10% risk: If baseline LDL-C is mg/dl, initiate simvastatin 40 mg daily. If baseline LDL-C is > 220 mg/dl, initiate simvastatin 80 mg daily. If baseline LDL-C is < 190 mg/dl, it is optional to measure hscrp in men > 50 years old and women > 60 years old, and if hscrp is > 2 mg/l, to initiate simvastatin 40 mg daily. (not fully EBM) Target LDL-C is <130 mg/dl. Caveats of CRP Measurement Do not use hscrp to monitor therapy. Information Regarding hscrp Ordering and Interpretation hscrp should be ordered only in metabolically stable patients who are free of active infection, systemic inflammation*, recent trauma and are not on estrogen therapy, immunosuppressants or glucocorticoids. If hscrp is > 2 mg/l, repeat hscrp two weeks later. Statin therapy contingent on hscrp is only recommended if two hscrp tests are both > 2 mg/l. If hscrp is > 10 mg/l, the patient should be evaluated for sources of infection or inflammation and the test repeated. The standard CRP test is not useful for cardiac risk assessment and should not be ordered for this purpose. The correct test is the highsensitivity CRP, sometimes called the cardio CRP or wide range CRP.

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