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Statin Landmark Trials Across the Spectrum of Risk: Primary CV Prevention

Statin Landmark Trials Across the Spectrum of Risk: Primary CV Prevention. Over Time Additional Risk Factors Can Progress: Effect of Cholesterol and BP on CHD Risk in MRFIT Trial. Deaths/10,000 patient-years. 34. Increasing Risk. N = 316,099. 23. 21. 18. 17. 17. 12. 13. 11. 14. 8.

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Statin Landmark Trials Across the Spectrum of Risk: Primary CV Prevention

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  1. Statin Landmark Trials Across the Spectrum of Risk: Primary CV Prevention

  2. Over Time Additional Risk Factors CanProgress: Effect of Cholesterol and BP on CHD Risk in MRFIT Trial Deaths/10,000 patient-years 34 Increasing Risk N = 316,099 23 21 18 17 17 12 13 11 14 8 12 10 9 8 8 6 6 5 245+ 142+ 6 6 6 132-141 221-244 4 3 125-131 203-220 Cholesterol quintile (mg/dL) SBP quintile (mm Hg) 3 118-124 182-202 <182 <118 BP = blood pressure; CHD = coronary heart disease. Neaton JD et al. Arch Intern Med. 1992;152:56-64..

  3. ASCOT LLA Trial of Statin in Hypertensive Patients With Additional Risk Factors: Patient Population All patients in ASCOT have hypertension plus 3 risk factors for CHD Hypertension Age ≥55 years 100 Male 84 Microalbumin/proteinuria 81 Smoker 62 Family history of coronary disease 33 Type 2 diabetes 26 Plasma TC:HDL-C ≥6 24 Certain ECG abnormalities 14 LVH 14 Previous cerebrovascular events 14 Peripheral vascular disease 10 0 10 20 30 40 50 60 70 80 90 100 5 Patients With Risk Factor, % Sever PS et al. J Hypertens. 2001;19:1139-1147.

  4. ASCOT LLA Primary End Point: Nonfatal MI and Fatal CHD 4 Atorvastatin 10 mg Placebo Number of Events 100 Number of Events 154 3 36% relative risk reduction 2 Cumulative Incidence, % 1 HR = 0.64 (95% CI, 0.50 – 0.83) P = .0005 0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Years Sever PS et al. Lancet. 2003;361:1149-1158.

  5. ASCOT LLA Secondary End Point: Fataland Nonfatal Stroke 3 Atorvastatin 10 mg Placebo Number of Events 89 Number of Events 121 27% relative risk reduction 2 Cumulative Incidence, % 1 HR = 0.73 (0.56 – 0.96) P = .0236 0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Years Sever PS et al. Lancet. 2003;361:1149-1158.

  6. HPS: Effects of Statin on Major Coronary Events and Stroke in Diabetic andNondiabetic Patients Vascular event Simvastatin Placebo Rate ratio & 95% CI & disease group (10269) (10267) Statin better Placebo better Major coronary events Diabetes 279 (9.4%) 377 (12.6%) No diabetes 619 (8.5%) 835 (11.5%) 27% (95% CI 21-33) All patients 898 (8.7%) 1212 (11.8%) reduction (P<0.0001) Strokes Diabetes 149 (5.0%) 193 (6.5%) No diabetes 295 (4.0%) 392 (5.4%) 25% (95% CI 15-34) All patients 444 (4.3%) 585 (5.7%) reduction (P<0.0001) 0.4 0.6 0.8 1.0 1.2 1.4 Collins et al. Lancet 2003;361:2005-2016.

  7. CARDS: Effect of Atorvastatin on thePrimary End Point—Major CV EventsIncluding Stroke Relative Risk Reduction 37% (95% CI, 17–52)P = 0.001 15 Placebo127 events 10 Cumulative Hazard, % 5 Atorvastatin83 events 0 0 1 2 3 4 4.75 Years 13061361 10221074 651694 305328 PlaceboAtorvastatin 14101428 13511392 Colhoun HM et al. Lancet 2004;364:685-696.

  8. Placebo* Atorva* Hazard Ratio Risk Reduction (95% CI) Event Primary end point 127 (9.0%) 83 (5.8%) 37% (17-52) p=0.001 Acute coronary events 77 (5.5%) 51 (3.6%) 36% (9-55) Coronary revascularization 34 (2.4%) 24 (1.7%) 31% (–16-59) Stroke 39 (2.8%) 21 (1.5%) 48% (11-69) CARDS: Component End Points * N (% randomized) .2 .4 .6 .8 1 1.2 Favors Atorvastatin Favors Placebo Colhoun HM et al. Lancet. 2004;364:685-696.

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