ODYSSEY OUTCOMES: Addition of PCSK9i to Background Statin Therapy Further Reduces MACE

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

    Steg PG, et al. Circulation. 2019; 140(2):103-12

MAT-BH-2100556/V1/JUN2021