WOSCOPS: West Of Scotland Coronary Prevention Study Purpose To determine whether pravastatin reduces combined incidence of nonfatal MI and death due to coronary heart disease (CHD) in patients with hypercholesterolemia Reference Shepherd J, Cobbe SM, Ford I et al. for the West of Scotland Coronary Prevention Study Group. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. New Engl J Med 1995:333:1301–7.

WOSCOPS: West Of Scotland Coronary Prevention Study - TRIAL DESIGN - Design Randomized, double-blind, placebo-controlled Patients 6595 male patients, aged 45–64 years, with high total cholesterol ( mg/dL, mmol/L) and LDL cholesterol (155 – 232 mg/dL, 4.0 – 6.0 mmol/L); patients with history of MI excluded Follow up and primary endpoint Combined primary endpoint: nonfatal MI and death due to CHD. Mean 4.9 years follow up Treatment Placebo or pravastatin 40 mg each evening

WOSCOPS: West Of Scotland Coronary Prevention Study - RESULTS - In pravastatin group, compared with placebo, significant reduction in: — Combined endpoint of nonfatal MI or death from CHD — Definite nonfatal MI — Death from all definite cardiovascular causes (1.6 vs. 2.3%, risk reduction 32%, P=0.033) — Myocardial revascularization procedures (1.7 vs. 2.5%, risk reduction 37%, P=0.009) Reductions in all-cause and CHD mortality not significant No differences in noncardiovascular death, including death from cancer, trauma or suicide With pravastatin, total and LDL cholesterol and triglycerides reduced by 20%, 26% and 12%, respectively; HDL cholesterol increased by 5% Drug well tolerated: similar withdrawal rate in both groups

WOSCOPS: West Of Scotland Coronary Prevention Study - RESULTS continued - Nonfatal MI or death from coronary heart disease Shepherd et al. N Engl J Med 1995; 333:1301–70. Years after randomization % with event Placebo Pravastatin 5-year relative RR 31% (95% CI 17–43%) P<0.001

WOSCOPS: West Of Scotland Coronary Prevention Study - RESULTS continued - Years after randomization % with event Nonfatal MI and death from coronary heart disease Definite nonfatal MI Death definitely from coronary heart disease Shepherd et al. N Engl J Med 1995; 333:1301– Placebo Pravastatin 5-year relative RR 31% (95% CI 15–45%) P< year relative RR 28% (95% CI –10–52%) P=0.13

WOSCOPS: West Of Scotland Coronary Prevention Study - SUMMARY - In patients with hypercholesterolemia and no history of MI, pravastatin reduced: Combined endpoint of nonfatal MI or death from CHD Nonfatal MI Death from all definite cardiovascular causes Need for myocardial revascularization procedures