6/28/23, 11:44 PM ODYSSEY OUTCOMES Pathway Feedback Search Clinical Topics Home Studies ODYSSEY OUTCOMES ODYSSEY OUTCOMES Disease Disease Non-ST-elevation myocardial inf ST-elevation myocardial infarction 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 N = 18924 75.0% male 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; low-density lipoprotein cholesterol < 70 mg/dL; ApoB < 80 mg/dL; non-high-density lipoprotein cholesterol < 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) https://web.pathway.md/studies/recxu6DHS3fD573vn 1/2 6/28/23, 11:44 PM ODYSSEY OUTCOMES Pathway Primary outcome Death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization 11.1 % 11.1 9.5 8.3 % 5.5 % Significant decrease 2.8 % NNT = 63 0.0 % Alirocumab Placebo Significant decrease in death from coronary heart disease, nonfatal myocardial infarction, 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 composite of death, nonfatal myocardial infarction, or nonfatal ischemic stroke (10.3% vs. 11.9%; HR 0.86, 95% CI 0.79 to 0.93) Significant decrease in coronary heart 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 heart disease, nonfatal myocardial infarction, 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. Open reference URL https://web.pathway.md/studies/recxu6DHS3fD573vn 2/2