The Effect of Pravastatin on Coronary Events after Myocardial Infarction in Patients with Average Ch...
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The Effect of Pravastatin on Coronary Events after Myocardial Infarction in Patients with Average Cholesterol Levels

Frank M. Sacks, M.D., Marc A. Pfeffer, M.D., Ph.D., Lemuel A. Moye, M.D., Ph.D., Jean L. Rouleau, M.D., J. Malcolm O. Arnold, M.D., Chuan-Chuan Wun, Ph.D., Barry Davis, M.D., Ph.D., Eugene Braunwald, M.D., for the Cholesterol and Recurrent Events Trial Investigators

N Engl J Med 1996; 335:1001-9


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CARE - Study Design Myocardial Infarction in Patients with Average Cholesterol Levels

  • Secondary prevention of CHD

  • 80 centers in the US and Canada

  • 4159 men and women aged 21 to 75 enrolled

  • 3 to 20 months post-MI

  • Total-C < 240; LDL-C between 115 and 174; Triglycerides < 350 mg/dL

  • 5 yr Treatment with Pravastatin 40 mg vs. placebo

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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CARE - Study Endpoints Myocardial Infarction in Patients with Average Cholesterol Levels

  • Primary:

    • CHD death or nonfatal MI

  • Secondary:

    • CHD death

  • Tertiary:

    • Total Mortality

  • Others:

    • Fatal MI, nonfatal MI, PTCA, CABG, Stroke

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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CARE - Baseline Characteristics Myocardial Infarction in Patients with Average Cholesterol Levels

  • 86% male; 14% female

  • Mean age 59 ± 9 years

  • 93% white

  • 21% current smoker

  • 42% hypertensive

  • 14% diabetic

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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CARE - Baseline Characteristics Myocardial Infarction in Patients with Average Cholesterol Levels

  • Mean 10 ± 5 months post-MI

  • 54% had prior PTCA / CABG

  • 83% taking aspirin

  • 41% taking b-blockers

  • 40% taking calcium antagonists

  • 15% taking ACEIs

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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Lipids at Baseline Myocardial Infarction in Patients with Average Cholesterol Levels

Plasma Lipid Placebo Pravastatin

(n=2078) (n=2081)

Cholesterol (mg/dL)

Total 209 209

VLDL 27 27

LDL 139 139

HDL 39 39

Triglycerides (mg/dL) 155 156

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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Percent LDL Reduction on Treatment Myocardial Infarction in Patients with Average Cholesterol Levels

P < 0.001 for all

comparisons

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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Fatal CHD or Nonfatal Myocardial Infarction Myocardial Infarction in Patients with Average Cholesterol Levels(Primary Endpoint)

24% Risk Reduction

p = 0.003

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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Coronary Bypass Surgery or Angioplasty Myocardial Infarction in Patients with Average Cholesterol Levels

27% Risk Reduction

p<0.001

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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CARE - Achievement of Endpoints Myocardial Infarction in Patients with Average Cholesterol Levels

  • Primary: CHD death or nonfatal MI

    • 24% reduction p = 0.003

  • Secondary: CHD death

    • 20% trend to reduction p = 0.10 (ns)

  • Tertiary: Total Mortality

    • 9% trend to reduction p = 0.37 (ns)

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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CABG/PTCA/Combined Myocardial Infarction in Patients with Average Cholesterol Levels

26% reduction (p=0.005)

PTCA

23% reduction (p=0.01)

Combined CABG/PTCA

27% risk reduction (p<0.001)

Other: Stroke

31% reduction (p=0.03)

CARE - Achievement of Endpoints

  • Fatal MI

    • 37% reduction (p=0.07)

  • Nonfatal MI

    • 23% reduction (p=0.02)

  • Combined MI endpoints

    • 25% reduction (p=0.002)

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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CARE - Observations Myocardial Infarction in Patients with Average Cholesterol Levels

  • Fatal CHD + nonfatal MI + CABG + PTCA

  • Women vs. Men:  46% vs.  20%

  • Current smokers vs. other:  33% vs.  22%

  • < 60 yr vs. > 60 yr:  20% vs.  27%

  • EF < 40% vs. > 40%:  28% vs.  23%

  • Hypertension, yes vs. no:  23% vs.  24%

  • Diabetes, yes vs. no:  25% vs.  23%

  • Prior PTCA/CABG, yes vs. no:  22% vs.  25%

p values for all subgroups were statistically significant

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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CARE - Observations Myocardial Infarction in Patients with Average Cholesterol Levels

  • Baseline LDL influence on Events*

    • LDL 125-150 26% p < 0.001

    • LDL < 125 3% p = 0.85

    • LDL > 150-175   p = 0.008

*Events included; fatal CHD, nonfatal MI, CABG or Angioplasty

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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CARE - Myocardial Infarction in Patients with Average Cholesterol Levels Safety

  • No difference in fatal and nonfatal primary cancers ... except

  • Breast Cancer:

    • Placebo (n=1)

    • Pravastatin (n=12), p=0.002*

Of the 12 breast cancer cases in the pravastatin group, all were nonfatal;

3 occurred in patients who had previously had breast cancer, 1 was ductal

carcinoma in situ, and 1 occurred in a patient who took pravastatin for

only six weeks.

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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Summary Myocardial Infarction in Patients with Average Cholesterol Levels

Cholesterol lowering with pravastatin in patients with MI and TC < 240 mg/dL

Reduced

Fatal CHD or nonfatal MI 24%

Fatal MI 37%

Nonfatal MI 23%

All MI, fatal or nonfatal 25%

Coronary artery bypass surgery 26%

Coronary angioplasty 23%

Stroke 31%

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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Expected Number of Cardiovascular Events Preventable by Treating 1000 Patients with Pravastatin for Five Years

Number of Events

Events Total Group Age > 60 Women

Fatal CHD 11 27 10

Nonfatal Ml 26 46 83

CABG 25 32 34

PTCA 37 20 66

Strokes TIA 13 25 28

Other Cardiovascular 38 57 7

All Cardiovascular Events 150 207 228

Patients with  1 event pre- 51 71 97

vented

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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Conclusion Treating 1000 Patients with Pravastatin for Five Years

  • These results demonstrate that the benefit of cholesterol-lowering therapy extends to the majority of patients with coronary disease who have average cholesterol levels

Sacks, F. et al, N Engl J Med 1996; 335:1001-9


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