Alirocumab 300 mg once-monthly reduced LDL-C by 64.8% at 48 weeks vs placebo in ASCVD patients without prior ACS or stroke, with similar safety profiles.
Does alirocumab 300 mg once-monthly reduce LDL-C and is it safe in adults with established ASCVD without prior ACS or stroke?
Alirocumab 300 mg once-monthly provides significant and sustained LDL-C reductions and is well tolerated in patients with established ASCVD without prior ACS or stroke.
Tasa de eventos absoluta: 0% vs 0%
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 included 116 patients (38 for placebo; 78 for alirocumab). Patients’ characteristics were similar between the groups (Table 1). Primary objectives - Significant improvements were observed in calculated LDL-C level from baseline to week 48 compared to placebo (LS mean reduction of 64.8%, p value vs placebo 0.0001) (Figure). The percentage of patients who experienced treatment-emergent adverse events (TEAE) were 71.9% and 87.2% and serious adverse events (SAE) were 15.4% and 17.5% in placebo and alirocumab groups, respectively. Secondary objectives - Significant improvements were observed in calculated LDL-C level from baseline to Week 12 (Figure), as well as in changes of apoB, Lp(a), and fasting TG at week 48 (all differences were statistically significant, p 0.0001 (Table 2). Conclusions This data support the use of alirocumab 300 mg Q4W as an efficacious and well tolerated dosing regimen for clinically meaningful and sustained LDL-C reductions among patients with established ASCVD and without previous ACS or stroke.
Tokgozoglu et al. (Sat,) reported a other. Alirocumab 300 mg once-monthly reduced LDL-C by 64.8% at 48 weeks vs placebo in ASCVD patients without prior ACS or stroke, with similar safety profiles.