ODYSSEY OUTCOMES Shows Significant Reduction in CV Risk
ORLANDO (March 10, 2018) – The ODYSSEY OUTCOMES trial results, announced today at the American College of Cardiology 67th Annual Scientific Sessions in Orlando, revealed the addition of alirocumab to maximally tolerated statin significantly reduced major adverse cardiovascular events (MACE) compared to those on maximally tolerated statin and placebo.
Additionally, the ODYSSEY OUTCOMES trial showed that adding alirocumab to maximally tolerated statin was associated with reduced death from any cause. The trial studied 18,924 patients experiencing recent acute coronary syndrome (ACS). The mean baseline was LDL-C 92 mg/dL and on-treatment LDL-C after 48 months was 53.3 mg/dL, a reduction of 54.7 percent.
“These results are exciting, as they continue to confirm the value of aggressive LDL cholesterol lowering in high risk patients well treated patients,” said National Lipid Association President James A. Underberg, M.D. “The data confirm the role of PCSK9 inhibitors as safe and efficacious inteventions in patients with high cardiovascular risk to improve outcomes.”
According to the data release, alirocumab reduced the overall risk of MACE by 15 percent. The results show the greatest impact on patients with baseline LDL-C level ≥100 md/dL, reducing MACE by 24 percent and overall death by 29 percent.
According to the ODYSSEY OUTCOMES investigators and committee, the data analysis revealed no significant safety issues, with the most commonly occurring adverse incidence being injection site reactions in those patients receiving alirocumab (3.8 percent) versus placebo (2.1 percent).