The Air Force/Texas
Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) is the first
coronary heart disease (CHD) primary prevention trial of the
cholesterol-
reducing agents called "
statins" to include women. For 5608 men and 997 postmenopausal women without clinical evidence of
cardiovascular disease (CVD) who had average
low-density lipoprotein cholesterol (
LDL-C) and below average
high-density lipoprotein cholesterol (HDL-C), 20-40 mg/day
lovastatin reduced first acute major coronary events (AMCEs) 37% (for those receiving placebo and
lovastatin, respectively, 183 and 116 first AMCEs defined as fatal or nonfatal
myocardial infarction [MI],
unstable angina, or
sudden cardiac death; relative risk [RR] 0.63; 95% confidence interval [95% CI] 0.50, 0.79; p < 0.001). Statistically significant reductions in prespecified secondary end points (coronary revascularizations,
unstable angina, MI, cardiovascular end point events, and coronary end point events) were also associated with
lovastatin treatment in the overall cohort. This paper provides results in women, a prespecified subgroup. Among women, 20-40 mg/day
lovastatin reduced
LDL-C 25% and increased HDLC 9% (p < 0.001). A prespecified analysis revealed consistency with the overall results regardless of gender (i.e., there were no statistical differences between men and women in risk reduction for first AMCEs with
lovastatin). However, the number of women who had an AMCE was small, and there was insufficient power to detect a treatment group difference among women (7 of 499 vs. 13 of 498 first AMCEs in those receiving
lovastatin and placebo, respectively; RR 0.54; 95% CI 0.22, 1.35; p = 0.183). Numerical reductions in all prespecified secondary end points were observed for women treated with
lovastatin, but again, the numbers of events were small and the differences were not statistically significant. Chronic long-term treatment with
lovastatin was well tolerated, with no treatment group differences in the frequency of
cancer, muscle symptoms, and clinically important liver
enzyme elevations. In AFCAPS/TexCAPS, a consistent pattern of numerical reductions in all prespecified primary and secondary cardiovascular end points was observed in women treated with
lovastatin for primary prevention of CHD. However, because of the small number of events, there was insufficient power to detect significant treatment group differences.
Lovastatin treatment was associated with statistically significant decreases in
LDL-C and increases in HDL-C, and chronic long-term treatment with 20-40 mg/day
lovastatin was well tolerated in women.