James Shepherd MD Stuart M Cobbe MD Ian Ford PhD Christopher G Isles MD A Ross Lorimer MD Peter W Macfarlane Ph D James H McKillop MD and Christopher J Packard D Sc for the West of Scotland Coronary Prevention Study Group ID: 426508
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Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia
James Shepherd, M.D., Stuart M. Cobbe, M.D., Ian Ford, Ph.D., Christopher G. Isles., M.D., A. Ross Lorimer, M.D., Peter W. Macfarlane, Ph. D., James H. McKillop, M.D., and Christopher J. Packard, D. Sc., for the West of Scotland Coronary Prevention Study Group
N Engl J Med 1995;333:1301-7Slide2
Background
This double-blind study was designed to determine whether the administration of pravastatin to men with hypercholesterolemia and no history of myocardial infarction reduced the combined incidence of nonfatal myocardial infarction and death from coronary heart disease
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide3
West of Scotland Coronary Prevention Study Group (WOS)
Randomized, double-blind, placebo controlled6595 men, 45 to 64 years of age Average follow-up of 4.9 years (seen at 3 month intervals)Pravastatin (40 mg each evening) vs. placebo
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide4
WOSBaseline Characteristics
Mean lipid levels:TC = 272 mg/dLLDL = 192 mg/dL
HDL = 44 mg/dL
Trigs = 162-164 mg/dL
5% of patients with angina
3% of patients with claudication8% of patients with abnormal EKG44% current smokers, 34% ex-smokers
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide5
WOSCOPS:
High Risk
Primary Prevention
Risk Factors...
1 risk factor: 100 %
2 risk factors: 44+ %
3 risk factors: ?
Family history: ?
Current CHD: 5+ %?
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide6
Endpoints
Primary
Non-fatal MI or coronary heart disease death as a first event
Secondary
Non-fatal MI
Coronary heart disease death
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide7
Other Endpoints
Cardiovascular mortalityTotal mortality
Coronary revascularization procedures
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide8
WOSReduction in Lipids
Pravastatin reduced lipid levels by*:20% reduction in TC26% reduction in LDL12% reduction in Trigs
5% increase in HDL
*Data analyzed according to the treatment actually received
not
according to the intention-to-treat principle
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide9
Effects of Pravastatin Therapy on Plasma LDL Cholesterol Levels
James Shepherd, et al, N Engl J Med 1995;333:1301-7
pravastatin (intention-to-treat)
pravastatin (actual treatment)
placebo (actual treatment)
placebo (intention -to-treat)Slide10
Nonfatal MI or CHD Death
(Primary Endpoint)
31%
Risk
Reduction
P=0.0001
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide11
Non-Fatal MI
(Secondary Endpoint)
31%
Risk
Reduction
P=0.0005
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide12
CHD Death
(Secondary Endpoint)
28%
Risk
Reduction
P=0.13
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide13
Cardiovascular Death
32%
Risk
Reduction
P=0.033
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide14
Coronary Interventions
Intervention Placebo Pravastatin Risk (n= 3293) (n=3302) Reductions p-value
Coronary
Angiography 128 90 31% 0.007
PTCA / CABG 80 51 37% 0.009
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide15
Total Mortality
P=0.051
22%
Risk
Reduction
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide16
WOS Results/Clinical Events
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide17
WOSConclusions
“Treatment with pravastatin significantly reduced the incidence of myocardial infarction and death from cardiovascular causes without adversely affecting the risk of death from noncardiovascular causes in men with moderate hypercholesterolemia and no history of myocardial infarction.”
James Shepherd, et al, N Engl J Med 1995;333:1301-7Slide18
Projected Benefits
Treatment of 1000 hypercholesterolemic middle aged
men with pravastatin for five years will avoid:
14 coronary angiograms
8 revascularization procedures
And avoid:20 nonfatal MIs
7 CHD deaths
2 additional deaths
James Shepherd, et al, N Engl J Med 1995;333:1301-7