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The Effect of Pravastatin on Coronary Events after Myocardial Infarction in Patients with Average Cholesterol Levels PowerPoint PPT Presentation


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

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

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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

  • 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

  • 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

  • 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

  • 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

Plasma LipidPlaceboPravastatin

(n=2078)(n=2081)

Cholesterol (mg/dL)

Total209 209

VLDL2727

LDL139139

HDL3939

Triglycerides (mg/dL)155156

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


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Percent LDL Reduction on Treatment

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 (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

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

  • Primary: CHD death or nonfatal MI

    • 24% reductionp = 0.003

  • Secondary: CHD death

    • 20% trend to reductionp = 0.10 (ns)

  • Tertiary: Total Mortality

    • 9% trend to reductionp = 0.37 (ns)

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


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CABG/PTCA/Combined

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

  • 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

  • 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 - 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

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

Reduced

Fatal CHD or nonfatal MI24%

Fatal MI37%

Nonfatal MI23%

All MI, fatal or nonfatal25%

Coronary artery bypass surgery26%

Coronary angioplasty23%

Stroke31%

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 CHD112710

Nonfatal Ml264683

CABG253234

PTCA372066

Strokes TIA132528

Other Cardiovascular38577

All Cardiovascular Events 150207228

Patients with  1 event pre-517197

vented

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


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Conclusion

  • 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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