ODYSSEY outcomes trial was a randomized double-blinded clinical trial on Alirocumab which is a PCSK9 inhibitor that showed its benefits in patients with CVD.
1. ODYSSEY Outcomes
Evaluation of Cardiovascular Outcomes
with Alirocumab after an ACS
Randomized, double-blind, placebo-controlled trial
Objective: To compare the safety and efficacy of
alirocumab compared with placebo among patients with recent
acute coronary syndrome (ACS) already on intensive or
maximum-tolerated statin therapy.
18,924
2018
Patients (>40 years) with ACS history within past
1-12 months, on maximum-tolerated statin therapy
with inadequate control of lipids were randomized
VS
primary outcome
secondary outcome
major adverse cardiac
events (MACE) %
alirocumab
q2 weeks SC
(n = 9,462)
placebo
(n = 9,462)
HR 0.85, 95% CI 0.78-0.93, p < 0.001.
Ischemia-driven coronary
revascularization %
P = 0.009
Death/MI/
ischemic stroke %
P = 0.0003
9.5 11.1
7.7 8.8
10.3 11.9
Conclusion: Among patients who had a previous ACS and who were
receiving high-intensity statin therapy, the risk of recurrent ischemic
cardiovascular events was lower among those who received
alirocumab than among those who received placebo.
Gregory G. Schwartz et al, NEJM, 2018; 379:2097-2107