WASHINGTON, DC—Data from the ODYSSEY trials shows that lower on-treatment low-density lipoprotein (LDL) cholesterol is associated with a lower risk of major adverse cardiovascular event (MACE) rate in both men and women. Findings from this study, led by Antonio Valleji-Vaz, were presented at the ACC.17 Scientific Session.
Previous studies involving statins have shown both men and women having similar risk reduction in cardiovascular (CV) disease events for every 39mg/dL reduction in LDL-C. Using pooled data from the Phase 3 ODYSSEY trials, researchers looked to see whether lower LDL-C would be associated with a lower MACE rate in women in addition to men. The ODYSSEY trials included patients with established CV disease or those at high risk with uncontrolled LDL-C (most on maximally tolerated statins) and compared treatment with alirocumab (a PCSK9 inhibitor) vs. placebo or ezetimibe (a cholesterol absorption inhibitor).
At baseline, the mean LDL-C was 121mg/dL in men and 135mg/dL in women. The average on-treatment LDL-C for men (n=3096) was 52mg/dL (alirocumab), 93mg/dL (ezetimibe), and 122mg/dL (placebo). For women (n=1882), the average on-treatment LDL-C was 71mg/dL (alirocumab), 114mg/dL (ezetimibe), and 134mg/dL (placebo).
For men, each 39mg/dL lower on-treatment LDL-C was linked to a 22% lower risk of MACE (adjusted hazard ratio [aHR] 0.78; P=0.0297); for women, risk of MACE was reduced by 29% (aHR 0.71; P=0.0459). No differences in safety were observed between the two groups and alirocumab was generally well-tolerated.
“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,” concluded the authors. The ongoing ODYSSEY OUTCOMES study will provide additional information on the link between lower on-treatment LDL-C and CV risk in both women and men.