ODYSSEY OUTCOMES Results Add to Growing Evidence Suggesting Benefits of PCSK9 Use in Highest-Risk Patients

The risk of recurrent ischemic cardiovascular events was lower in patients on high-intensity statin therapy who received alirocumab following an acute coronary syndrome than those who received placebo, based on findings from ODYSSEY OUTCOMES published Nov. 7 in the New England Journal of Medicine.

The large multi-center trial involved 18,924 patients who had experienced an acute coronary syndrome within one to 12 months prior; had an LDL-C level of >70 mg per deciliter; a non-high-density lipoprotein cholesterol level of at least 100 mg per deciliter; and were on high-intensity statin therapy. Researchers randomly assigned patients to receive alirocumab (70 mg) subcutaneously or matching placebo every two weeks. Alirocumab dosing was adjusted under blinded conditions to target an LDL cholesterol level of 25 to 50 mg per deciliter. Median follow-up was 2.8 years. The primary endpoint was a composite of death from coronary heart disease, nonfatal myocardial infarction (MI), ischemic stroke or unstable angina requiring hospitalization.

Results found the primary endpoint occurred in 9.5% (903 patients) in the alirocumab group compared with 11.1 percent (1,052) in the placebo group. Researchers noted 3.5 percent of patients in the alirocumab group died compared with 4.1 percent in the placebo group. They also observed that patients with a baseline LDL-C level of 100 mg or more per deciliter saw the greatest benefits from alirocumab with respect to the primary endpoint. In terms of safety, the incidence of adverse events and of laboratory abnormalities was similar across both groups with the exception of local injection-site reactions, which occurred more frequently in the alirocumab group (3.8 percent vs. 2.1 percent).

ODYSSEY OUTCOMES joins FOURIER and SPIRE, in adding to the growing body of research evaluating PCSK9 inhibitors in reducing vascular events. Compared with the other two trials, ODYSSEY OUTCOMES had a longer duration of follow-up that allowed for assessment of efficacy and safety. It also addressed high-risk patients who had a previous acute coronary syndrome. ODYSSEY OUTCOMES researchers said the infrequent use of ezetimibe was a limitation of all three trials and that additional research is warranted.

Keywords: Cholesterol, LDL, Acute Coronary Syndrome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Brain Ischemia, Stroke, Angina, Unstable, Antibodies, Monoclonal, Lipoproteins, Coronary Disease, Myocardial Infarction, Hospitalization

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