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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.

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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.

  9. JUPITER Trial of Statin in People WithElevated CRP: Primary End Point Time to first occurrence of a CV death, nonfatal stroke, nonfatalMI, unstable angina, or arterial revascularization 0.08 Placebo HR = 0.56 (95% CI, 0.46-0.69) P < .00001 0.06 Rosuvastatin 20 mg 0.04 Cumulative Incidence 0.02 0.00 0 1 2 3 4 Follow-up (years) Patients at risk Rosuvastatin 8901 8631 8412 6540 3893 1958 1353 983 538 157 Placebo 8901 8621 8353 6508 3872 1963 1333 955 534 174 JUPITER, Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin. RidkerP et al. N Eng J Med. 2008;359:2195-2207.

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