The ODYSSEY OUTCOMES ( Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab ) trial compared Alirocumab ( Praluent ) with placebo, added to high-intensity or maximum-tolerated statin treatment, after acute coronary syndrome ( ACS ) in 18,924 patients.
Alirocumab has reduced the first occurrence of the primary composite endpoint and was associated with fewer all-cause deaths.
A pre-specified analysis has determined the extent to which Alirocumab has reduced total ( first and subsequent ) nonfatal cardiovascular events and all-cause deaths in ODYSSEY OUTCOMES.
With 3,064 first and 5,425 total events, 190 fewer first and 385 fewer total nonfatal cardiovascular events or deaths were observed with Alirocumab compared with placebo.
Alirocumab has reduced total nonfatal cardiovascular events ( hazard ratio: 0.87; 95% confidence interval: 0.82 to 0.93 ) and death ( HR=0.83; 95% confidence interval: 0.71 to 0.97 ) in the presence of a strong association between nonfatal and fatal event risk.
In patients with acute coronary syndrome, the total number of nonfatal cardiovascular events and deaths prevented with Alirocumab was twice the number of first events prevented.
Consequently, total event reduction is a more comprehensive metric to capture the totality of alirocumab clinical efficacy after acute coronary syndrome. ( Xagena )
Szarek M et al, J Am Coll Cardiol 2019;73:387-396