ODYSSEY OUTCOMES
Trial question
What is the role of alirocumab in patients following acute coronary syndrome who are receiving high-intensity statin therapy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 18924
18924 patients (4762 female, 14162 male).
Inclusion criteria: patients with acute coronary syndrome 1-12 months earlier who have qualifying lipid levels and are receiving high-intensity statin therapy.
Key exclusion criteria: age < 40 years; LDL-C < 70 mg/dL; ApoB < 80 mg/dL; non-HDL-C < 100 mg/dL; acute coronary syndrome event occurring > 52 weeks prior to randomization.
Interventions
N=9462 alirocumab (subcutaneous dose of 75 mg every 2 weeks).
N=9462 placebo (matching placebo every 2 weeks).
Primary outcome
Death from coronary artery disease, nonfatal MI, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization
9.5%
11.1%
11.1 %
8.3 %
5.5 %
2.8 %
0.0 %
Alirocumab
Placebo
Significant
decrease ▼
NNT = 62
Significant decrease in death from coronary artery disease, nonfatal MI, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization (9.5% vs. 11.1%; HR 0.85, 95% CI 0.78 to 0.93).
Secondary outcomes
Significant decrease in death, nonfatal MI, or nonfatal ischemic stroke (10.3% vs. 11.9%; HR 0.86, 95% CI 0.79 to 0.93).
Significant decrease in coronary artery disease event (12.7% vs. 14.3%; HR 0.88, 95% CI 0.81 to 0.95).
Significant decrease in cardiovascular event (13.7% vs. 15.6%; HR 0.87, 95% CI 0.81 to 0.94).
Safety outcomes
No significant difference in adverse events.
Significant difference in local injection site reaction (3.8% vs. 2.1%).
Conclusion
In patients with acute coronary syndrome 1-12 months earlier who have qualifying lipid levels and are receiving high-intensity statin therapy, alirocumab was superior to placebo with respect to death from coronary artery disease, nonfatal MI, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.
Reference
Gregory G Schwartz, P Gabriel Steg, Michael Szarek et al. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018 Nov 29;379(22):2097-2107.
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