Alirocumab cuts nonfatal outcomes among statin-treated ACS survivors: ODYSSEY OUTCOMES

  • Szarek M & al.
  • J Am Coll Cardiol
  • 5 Feb 2019

  • curated by Jenny Blair, MD
  • Clinical Essentials
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Takeaway

  • 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.  

Key results

  • 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). 

Study design

  • 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.

Limitations

  • Apparent links between nonfatal events and death might trace to residual confounding.

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