Physicians' Academy for Cardiovascular Education

Another PCSK9 inhibitor safely reduces MACE in long term outcomes trial in high-risk patients

The ODYSSEY OUTCOMES Trial: Topline Results - Alirocumab in Patients After Acute Coronary Syndrome

Presented at ACC.18 by Ph. Gabriel Steg (Paris, France)

Mar. 9, 2018 - news


Patients who have experienced a myocardial infarction (MI), show a high cardiovascular event risk in the first year following the event, despite lipid-lowering treatment, as well as in the 3.5 years after that. Thus, additional treatment is needed to lower this residual CV risk.

Alirocumab is a PCSK9 inhibitor that lowers LDL-c, the efficacy and longer term safety of which was evaluated in the ODYSSEY OUTCOMES trial. Participants had experienced an acute coronary syndrome (ACS, MI or unstable angina) 1 to 12 months prior to randomization. Patients were on high-intensity statin therapy (atorvastatin 40 to 80 mg daily or rosuvastatin 20 to 40 mg daily or maximum tolerated dose of one of these agents for ≥2 weeks) and showed inadequate control of lipids despite therapy (LDL-c ≥70 mg/dL (1.8 mmol/L) or non-HDL-c ≥100 mg/dL (2.6 mmol/L) or apolipoprotein B ≥80 mg/dL. 18924 patients were randomized to either alirocumab (75 or 150 mg Q2W) or placebo, and followed for a median of 2.8 years. Treatment target was LDL-c levels between 25 and 50 mg/dL, and allowing levels as low as 15 mg/dL. 1955 Patients experienced a primary endpoint (major adverse cardiovascular events (MACE): coronary heart disease (CHD) death, non-fatal MI, ischemic stroke, or unstable angina requiring hospitalization) and 726 patients died.

Main results


These results of the ODYSSEY OUTCOMES study show that compared with placebo, in patients with recent ACS, alirocumab 75 or 150 mg Q2W reduced the primary endpoint of MACE. Moreover, a secondary analysis showed that alirocumab treatment was associated with a lower rate of all-cause death. Treatment with this PCSK9 inhibitor was safe and well tolerated over the duration of the trial.


Our coverage of ACC.18 is based on the information provided during the congress.