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