- For patients taking high-intensity statins after acute coronary syndrome (ACS), alirocumab (Praluent, Sanofi US and Regeneron Pharmaceuticals, Inc.) prevents approximately twice as many nonfatal events as first nonfatal events.
- Study furnishes additional evidence of benefit of alirocumab.
- Editorial : “to analyze recurrent events in a clinical trial is atypical but, in the present case, very informative….[the study] provides a very encouraging signal.”
Why this matters
- ODYSSEY OUTCOMES previously demonstrated lower first incidence of major cardiovascular (CV) events.
- By accounting for death censoring otherwise potentially preventable recurrent nonfatal outcomes, this study aims to derive more accurate HRs.
- At 4 years, alirocumab vs placebo:
- Number of total nonfatal CV events: 0.301 vs 0.357.
- Number of first nonfatal CV events: 0.160 vs 0.183.
- Alirocumab vs placebo:
- Total nonfatal cardiovascular events: HR, 0.87 (95% CI, 0.82-0.93).
- Death: HR, 0.83 (95% CI, 0.71-0.97).
- Planned secondary analysis of ODYSSEY OUTCOMES, which compared alirocumab vs placebo added to maximal statin treatment after ACS (n=18,924).
- This study assessed alirocumab’s effect on total (first and subsequent) nonfatal CV events, all-cause deaths.
- Funding: Sanofi, Regeneron Pharmaceuticals, Inc., Fondation Assistance Publique—Hôpitaux de Paris.
- Apparent links between nonfatal events and death might trace to residual confounding.