[{"id":"odyssey-mace","name":"MACE (CHD death, non-fatal MI, ischemic stroke, unstable angina hospitalization)","type":"PRIMARY","unit":"HR","results":[{"notes":"903 events (9.5%)","value":9.5,"arm_id":"alirocumab-odyssey","arm_name":"Alirocumab"},{"notes":"1052 events (11.1%)","value":11.1,"arm_id":"placebo-odyssey","arm_name":"Placebo"},{"notes":"HR 0.85 (95% CI 0.78-0.93), p=0.0003. 15% relative reduction in MACE.","value":0.85,"arm_id":"treatment-effect","p_value":"0.0003","arm_name":"Hazard Ratio","ci_lower":0.78,"ci_upper":0.93}],"timepoint":"Median 33 months","description":"Time to first MACE event: composite of coronary heart disease death, non-fatal myocardial infarction, fatal/non-fatal ischemic stroke, or unstable angina requiring hospitalization. This is the gold-standard CV outcomes endpoint."}]

ODYSSEY Outcomes met primary endpoint: 15% reduction in MACE (HR 0.85, 95% CI 0.78-0.93, p=0.0003). Numerically reduced all-cause mortality (3.5% vs 4.1%). Established that PCSK9 inhibition reduces CV events in post-ACS patients on maximally tolerated statins.

ODYSSEY Outcomes (n=18,924, median 33 months): Well-tolerated. Injection site reactions 3.8% vs 2.1%. Myalgia 6% vs 5%. Allergic reactions leading to discontinuation 0.6% vs 0.2%. No neurocognitive safety signal.

ODYSSEY Outcomes is the definitive PCSK9 outcomes trial. 15% MACE reduction (HR 0.85, p=0.0003) in 18,924 post-ACS patients. Key differentiator vs FOURIER: ODYSSEY showed a nominal mortality reduction (3.5% vs 4.1%) — not statistically significant but directionally important. The ACS population is higher-risk with more to gain. This data is why PCSK9 inhibitors are now guideline-recommended after ACS.

PCSK9 inhibition dramatically lowers LDL-C. ODYSSEY tested whether this translates to CV outcomes benefit in ACS patients.