WASHINGTON, D.C. — Despite women having slightly higher on-treatment low-density lipoprotein cholesterol (LDL-C) levels compared with men, they derived the same cardiovascular benefits in statin trials, according to an analysis presented at the 66th Annual Scientific Session & Expo of the American College of Cardiology.
Researchers from Regeneron Pharmaceuticals and Sanofi Aventis collected data from 10 phase 3 ODYSSEY clinical trials that compared alirocumab vs placebo or ezetimibe in patients with established cardiovascular disease or high disease risk with uncontrolled LDL-C. Most patients were on a maximally tolerated statin. Using multivariable Cox regression, the researchers assessed the association between 39 mg/dL lower on-treatment LDL-C and major adverse cardiac events (MACE) in men vs women.
In men the mean baseline LDL-C was 121 mg/dL, and in women the mean baseline LDL-C was 135 mg/dL. The average on-treatment LDL-C levels were 52 mg/dL with alirocumab, 93 mg/dL with ezetimibe, and 122 mg/dL with placebo.
Each decrease of 39 mg/dL on-treatment LDL-C was associated with a 22% lower risk of MACE in men (P =.0297) and 29% lower risk in women (P =.0459; P-heterogeneity =.6427).
“Although women in these trials had a slightly higher on-treatment LDL-C than men, both women and men showed a lower risk of MACE with lower LDL-C levels,” the researchers concluded.
Vallejo-Vaz A, Ginsberg H, Davidson M, et al. Lower on-treatment low-density lipoprotein cholesterol is associated with lower cardiovascular risk in women: analyses from the ODYSSEY trials of alirocumab vs control. Abstract 1204-331. Presented at: the 66th Annual Scientific Session & Expo of the American College of Cardiology. March 17-19, 2017; Washington, DC.