Odyssey outcomes - mortality

Odyssey Outcomes: Addition of PCSK9i to background Statin therapy further reduces MACE

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Mortality study results

Effect of Alirocumab on All-Cause, CV or Non-CV death

*Stratified by geographic region. †Nominal p-value, as all-cause death followed CHD death and cardiovascular death in tile prespecified hierarchy of main secondary endpoints, the p-value for all-cause death was considered nominal

All-cause death: All patients vs patients eligible for ≥3 years of follow-up

*Because all-cause death followed CHD death and CV death in the pre specified hierarchy or main secondary endpoints, the p-value for all-cause death was considered nominal. Alirocumab is associated with lower all-cause death as compared to placebo. Patients were eligible for ≥3 years or follow-up if randomized ≥3 years before the common study end date.

**First year HR 1.01 (95% Cl 0.77, 1.32); for patients eligible for <3 years of follow-up HR 0.96 (95% Cl 0.76, 1.21).

Post-hoc analysis: All-cause death by baseline LDL-C subgroups

Relative risk reduction: Pinteraction=0. 12

Absolute risk reduction: Pinteraction=0.005

*Based on cumulative incidence, alirocumab is associated with lower all-cause death as compared to placebo

Mortality study conclusions

• The risk of non-CV death is usually assumed to be independent of risk of CV events, and there is unmodifiable risk by LDL-C lowering
• In the post-hoc, joint semiparametric modelling approach, alirocumab treatment was associated with a favorable effect on risk of nonfatal CV events and was a predictor of non-CV death. The association parameter indicates that these risks are linked

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