ODYSSEY OUTCOMES Trial meets primary outcome

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the ODYSSEY OUTCOMES trial met its primary endpoint, showing Praluent® (alirocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event such as a heart attack.

This demostrates that high-risk patients who added Praluent® (alirocumab) to maximally-tolerated statins experienced significantly fewer major adverse cardiovascular events compared to those on maximally-tolerated statins alone

For the first time, adding a lipid-lowering therapy to maximally-tolerated statins was associated with reduced death from any cause

More pronounced effect observed in patients with baseline LDL-C levels at or above 100 mg/dL despite maximally-tolerated statins, who are at high risk of suffering a future event; in this group, Praluent reduced risk of major adverse cardiovascular events by 24% and was associated with a 29% lower risk of death overall

In this 18,924-patient, long-term trial, the safety profile of Praluent was consistent with previous trials and no new safety issues were observed

Full press release available here

The New England Journal of Medicine article is available here