Abstract 17306: Impact of Female Sex on Lipid Lowering and Relationship of Lipids to Clinical Outcomes in Atorvastatin Trials
Objectives: We evaluated the effect of atorvastatin (A) on lipid lowering in women in 6 large clinical trials. We also determined whether there were any sex differences in the relationship of on treatment LDL-C to cardiovascular (CV) events.
Methods: In IDEAL (A 80 mg vs. simvastatin 20-40 mg), TNT (A 80 mg vs. A 10 mg), SPARCL (A 80 mg vs. placebo), CARDS, ASCOT, and ASPEN (A 10 mg vs. placebo for all 3 studies), changes from baseline lipid levels over time by treatment were compared between sexes by separate analyses in IDEAL/TNT, SPARCL and in CARDS/ASCOT/ASPEN. The association of on-study LDL-C and CV events by sex was evaluated by Cox regression of the combined results of the 6 studies.
Results: Major CV events defined as non-fatal MI, CHD death, resuscitated cardiac arrest, or stroke occurred in 3083 of 30,000 men (10.3%) and 823 of 9173 women (9.0%). In low dose trials, A 10 mg lowered LDL-C at 3 months in men (-1.203 mmol/L, 95%CI: -1.234,-1.171) and in women (-1.292 mmol/L, 95%CI: -1.341,-1.243) P=.002 (treatment*gender interaction). In two of the higher dose studies (IDEAL and TNT), there was a significant sex interaction by treatment effect on LDL-C. Major CV events and non-fatal MI were significantly positively associated with sex-specific quintiles of LDL-C at Month 3 for both men and women (Table). The association of major CV events and LDL-C was similar for men and women (HR 1.14 per 1 mmol/L LDL-C, 95% CI: 1.08, 1.21 for men and HR 1.21, 95% CI: 1.09, 1.33 for women). However, the pattern of association with components of CV events was different; the association with CHD death was stronger in men than women while the association with stroke was stronger in women than men.
Conclusions: In these lipid-lowering trials, both women and men had significant reductions in LDL-C. LDL-C at Month 3 was significantly positively associated with major CV events and non-fatal MI in both sexes; however, the association with stroke was stronger in women while men had a stronger association with CHD death.
- © 2013 by American Heart Association, Inc.