Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (Mega Study)

Introduction

5000 postmenopausal women in a randomized trial of:

• diet alone (NCEP step 1 diet) or
• diet plus pravastatin

to prevent CVD

age range, 40-70 years,

elevated total cholesterol levels 220-272 mg/dL

no history of cardiovascular disease

mean follow-up of 5.3 years

Pravastatin was initiated at 10 mg per day & was adjusted to 20 mg per day if total cholesterol did not decrease below 219 mg/dL

Results: (at 5 years of follow-up)

• mean TC had decreased by 2.7% in the diet group & by 11.8% in the diet plus pravastatin group
• compared with women in the diet group, those receiving pravastatin experienced lower incidence of
  • coronary heart disease (hazard ratio, 0.75)
  • stroke (HR, 0.63)
  • myocardial infarction (HR, 0.65)
• none of the differences were statistically significant
• however, women 55 or older in the diet plus pravastatin group had significantly fewer strokes than did those in the diet group (HR, 0.47; P=0.02)
• all women receiving pravastatin had a significant reduction in all-cause mortality, compared with those assigned to diet alone (HR, 0.59; P=0.046), although this reduction was primarily related to non-cardiovascular disease (i.e. cancer)

More general terms

• clinical trial