ODYSSEY Outcomes: Alirocumab Linked with Reduced Cardiovascular Events following ACS

In patients who recently suffered an acute coronary syndrome (ACS), the PCSK9 inhibitor alirocumab was associated with a 15% reduction in major adverse cardiovascular events (MACE), according to results of the ODYSSEY Outcomes study presented at the American College of Cardiology 2018 Scientific Sessions in Orlando (ACC.18).  

The researchers for the study enrolled 18,924 patients with recent ACS (defined as myocardial infarction or unstable angina) who were taking 40-80 mg atorvastatin per day, rosuvastatin 20-40 mg/d, or the maximum tolerated dose of both. Patients had a residual LDL-C ≥mg/dL, non-HDL-C ≥100 mg/dL, or apolipoprotein B ≥80 mg/dl. Patients were randomized to alirocumab 75 mg every two weeks, or to placebo and were followed out to at least 2 years.  

According to the results, the primary study endpoint occurred in 9.5% of patients in the alirocumab group versus 11.1% in the placebo group (HR=0.85, 95% CI, 0.78-0.93; p=0.0003) with no significant difference in heart disease or cardiovascular disease deaths between the two groups. Also reported was a decrease in all-cause death in the alirocumab group vs. placebo (nominal p-value=0.026). Alirocumab was reported safe and well-tolerated in the patient population for the duration of the study. 

The ODYSSEY Outcomes study was the second trial to show the benefit from PCSK9 inhibitors, with the other being 2017’s FOURIER trial. 

For more information on the ODYSSEY Outcomes trial, click here