Effects of lovastatin and warfarin on early carotid atherosclerosis - Sex-specific analyses

Background-Few clinical trials have documented the efficacy of preventive t reatment in asymptomatic women. Methods and Results-Lovastatin and minidose warfarin were evaluated in a fa ctorially designed, placebo-controlled, randomized trial. The primary outco me was 3-year change in the mean maximum intimal-medial thickness of the ca rotid arteries as measured by B-mode ultrasonography, Participants (n=919) were randomized to 1 of 4 treatment groups: lovastatin alone, warfarin alon e, lovastatin + warfarin combination, or a double-placebo group. Eligible p articipants were asymptomatic for cardiovascular disease, with evidence of early carotid atherosclerosis and-moderately elevated LDL cholesterol level . Almost half (n=445) of the participants were women. To avoid confounding, 117 women taking estrogen were excluded from analysis. Both sexes experien ced reductions in disease progression with lovastatin; there was no evidenc e of an overall sexXtreatment interaction (P=0.72), When estimates of the s ex-specific results were examined post hoc, women experienced disease regre ssion to the greatest extent with the lovastatin+warfarin combination (P=0. 02), although the women on lovastatin alone also had a reduction in progres sion (P=0.09), Men experienced the greatest reduction with lovastatin alone (P=0.02), although there is a suggestion that warfarin may also reduce pro gression to some extent. Conclusions-Lovastatin is beneficial in reducing disease progression in wom en and men. Warfarin has no effect in women, although it may reduce progres sion in men. In men, warfarin does not add to the benefit of lovastatin and has no advantage over lovastatin alone.