Authors
Downs JR., Clearfield M., Weis S.
Title
Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study
References
JAMA. 1998 May 27;279(20):1615-22.
Background
Epidemiological observations have demonstrated consistently a strong positive, continuous, independent, graded relation between plasma total cholesterol (TC) and the incidence of coronary heart disease (CHD). This relation covers a wide range of cholesterol concentrations, including those considered normal or mildly elevated. However, it is unknown whether benefit from reduction of low-density lipoprotein cholesterol (LDL-C) in patients without CHD (primary prevention) extends to individuals with average serum cholesterol levels, women, and older persons.
Purpose
AFCAPS/TexCAPS was designed to investigate whether long-term lipid lowering with lovastatin would decrease the rate of first acute major coronary events compared with placebo during at least 5 years of follow-up in a cohort without clinical evidence of atherosclerotic cardiovascular disease and with average TC and LDL-C levels and below-average HDL-C levels.
Design
  • Randomized, double-blind, placebo controlled trial
  • 6605 men and women (aged 55-73 years) without prior history of myocardial infarction, angina, claudication or stroke
  • Total cholesterol 4.65-6.82 mmol/L; LDL-C 3.36-4.91mmol/L; HDL-C <1.16 mmol/L (men) or <1.22 mmol/L (women)
Exclusion Criteria
  • Uncontrolled hypertension
  • Secondary hyperlipidemia
  • Type 1 or 2 diabetes on insulin or HbA1c >10%
  • Body weight more than 50% appropriate for height (as per insurance tables)
Follow-Up
Average 5.2 years
Treatment Regimen
  • Lovastatin 20-40mg/day vs. placebo in addition to low saturated fat, low-cholesterol diet
  • Lovastatin titrated to 40mg/day if LDL-C >2.84mmol/L at the 3 month study visit
Results

Primary Endpoints

The primary endpoint analysis was the incidence of first acute major coronary events, defined as fatal or nonfatal myocardial infarction, unstable angina, or sudden cardiac death

LovastatinCIHRp
Lovastatin reduced primary endpoint
0.6395%0.50-0.79<0.001

Secondary Outcomes

(see study for additional endpoints)

LovastatinCIHRp
Reduction in myocardial infarction
0.6095%0.43-0.830.002
Reduction in unstable angina
0.6895%0.49-0.950.02
Summary
Lovastatin (20-40mg/day) reduces the risk for the first acute major coronary event in men and women with average total cholesterol and LDL-C levels and below-average HDL-C levels. The trial findings support the inclusion of HDL-C in risk-factor assessment, confirm the benefit of LDL-C reduction to a target goal, and suggest the need for reassessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention.