WOSCOPS trial - pravastatin

WOSCOPS Trial: Prevention of CAD with Pravastatin

WOSCOPS Trial Summary

WOSCOPS trial was a double-blind, parallel-group, randomized, placebo-controlled trial that was designed to assess the benefit of pravastatin in reducing CV events in men with hyperlipidemia.

In total 6,595 men of age 45-64 years with total cholesterol ≥252 mg/dL on initial screening, LDL ≥155 mg/dL at visits 2 and 3 or LDL ≥174 but ≤232 mg/dL at one or both of screening visits 2 and 3 were randomized to:

Pravastatin (n=3,302)

Placebo (n=3,293)

The primary outcome of Nonfatal MI or death from CAD occured in 5.5% of patients receiving pravastatin compared to 7.9% in placebo group. (RR 0.69; 95% CI 0.57-0.83; P<0.001).

The authors of the WOSCOPS trial concluded that treatment with pravastatin significantly reduced the incidence of MI and death from CV causes without adversely affecting the risk of death from noncardiovascular causes in men with moderate hypercholesterolemia and no history of MI.

Key Points:

  • Coronary event rates were higher in the placebo group by more than 10% at 5 years in men with pre-existing vascular disease or age >55 years with one or more CAD risk factors. Thus pravastatin showed more benefit in secondary prevention compared to primary prevention.
  • Three times more men had to be treated for five years to prevent one endpoint in the WOSCOPS trial as compared to 4S trial.