Administration of alirocumab in patients with a history of an acute coronary syndrome (ACS) and already receiving high-intensity statin therapy, reduces the risk of recurrent ischemic cardiovascular events compared to placebo, show results from ODYSSEY OUTCOMES trial.
Patients who have had acute coronary syndrome are at high risk for recurrent ischemic cardiovascular events.
Gregory G. Schwartz, Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, and colleagues sought to determine whether alirocumab, a human monoclonal antibody to proprotein convertase subtilisin–kexin type 9 (PCSK9), would improve cardiovascular outcomes after ACS in patients receiving high-intensity statin therapy.
This multicenter, randomized, double-blind, placebo-controlled trial involved 18,924 patients who had ACS 1 to 12 months earlier and were receiving statin therapy at a high-intensity dose. Patients were randomized to receive alirocumab (9462 patients) or placebo (9462 patients) every 2 weeks.
The primary endpoint was a composite of death from nonfatal myocardial infarction, coronary heart disease, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.
- After a median follow-up of 2.8 years, a composite primary end-point event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group.
- A total of 334 patients (3.5%) in the alirocumab group and 392 patients (4.1%) in the placebo group died.
- The absolute benefit of alirocumab with respect to the composite primary endpoint was greater among patients who had a baseline LDL cholesterol level of 100 mg or more per deciliter than among patients who had a lower baseline level.
- The incidence of adverse events was similar in the two groups, with the exception of local injection-site reactions (3.8% in the alirocumab group vs. 2.1% in the placebo group).
Based on the study, the authors concluded that among patients who had a previous acute coronary syndrome and who were receiving high-intensity statin therapy, the risk of recurrent ischemic cardiovascular events was lower among those who received alirocumab than among those who received placebo.
For further reference log on to 10.1056/NEJMoa1801174