The effect of alirocumab on cardiovascular events: What did the ODYSSEY OUTCOMES Trial show?

Summary

Patients after acute coronary syndrome (ACS) remain at high risk for other cardiovascular (CV) events even when all the measures within secondary prevention are used. The ODYSSEY OUTCOMES Trial tested the effects of proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9) in patients with ACS, who had higher cholesterol levels remaining despite high-dose statin therapy (LDL-cholesterol > 1.8 mmol/L). The study included 18,924 individuals who were randomized to receive alirocumab therapy or placebo. The dose of alirocumab was blindly adjusted to achieve an LDL-cholesterol value of 0.6–1.3 mmol/L. The median follow-up was 2.8 years. Alirocumab significantly reduced the risk of another CV event (primary composite endpoint death from coronary heart disease, non-fatal myocardial infarction, ischemic stroke, unstable angina) by 15%. Treatment with alirocumab was also associated with lower total mortality. Alirocumab not only reduced the risk of the first CV event, but also subsequent events. The effects of alirocumab were the most pronounced in subgroups with the highest initial LDL-cholesterol value (> 2.6 mmol/L) and in patients treated with alirocumab for more than 3 years. Treatment with alirocumab was safe, only a local reaction at the injection site was a more common adverse effect of alirocumab compared to placebo. In coclusion, alirocumab, when added to intensive statin therapy in patients with ACS, significantly reduced the risk of recurrent CV event, and treatment with alirocumab was associated with lower total mortality.

Keywords:

alirocumab – mortality – unstable angina – acute coronary syndrome