Efficacy and safety of Alirocumab once-monthly dosing in patients with atherosclerotic cardiovascular disease and without acute coronary syndrome or stroke; an ODYSSEY CHOICE I analysis

作者：L Tokgozoglu, Y Arbel, M Orsini, C Bonanad Lozano, Hagai Tavori, Tienush Rassaf, P. Perrone-Filardi, M Vrablik · 发表于：European Heart Journal · 年份：2025 · DOI：10.1093/eurheartj/ehaf784.3729 · 研究领域：Lipoproteins and Cardiovascular Health、Atherosclerosis and Cardiovascular Diseases、Antiplatelet Therapy and Cardiovascular Diseases

Abstract Background and Aims To determine the efficacy and safety of alirocumab once-monthly dosing (300 mg Q4W) versus placebo in patients with established atherosclerotic cardiovascular disease (ASCVD) and without previous acute coronary syndrome (ACS; myocardial infarction/unstable angina) or stroke in the ODYSSEY CHOICE I study (NCT01926782). Methods Data were analyzed from the Phase 3 ODYSSEY CHOICE I study with alirocumab 300 mg Q4W as an add-on to statin or with no statin therapy. Adults with established ASCVD (peripheral artery disease [PAD] with diabetes, coronary artery disease [CAD] with diabetes, or established CAD) and without prior ACS or stroke were included. Efficacy and Safety data were analyzed for dosage of 300 mg of alirocumab Q4W and placebo in Intention to treat (ITT) population. The primary objectives of this analysis were percentage change in calculated low-density lipoprotein cholesterol (LDL-C) at Week 48 compared to Placebo, and percentage of patients with adverse events. Secondary objectives of this analysis were percentage change in calculated LDL-C level from baseline to Week 12, and percentage change in apolipoprotein B (apoB), lipoprotein(a) [Lp(a)], and fasting triglycerides (TG) from baseline to week 48. Results There were 117 patients identified with established ASCVD and without previous ACS or stroke. A total of 39 patients were randomized for placebo treatment and 78 patients were randomized for Alirocumab treatment. ITT population includ...