ALIROCUMAB EFFICACY AND SAFETY IN PATIENTS WITH HYPERCHOLESTEROLEMIA AND WITH OR WITHOUT CLINICAL ATHEROSCLEROTIC CARDIOVASCULAR DISEASE: POOLED ANALYSIS OF 10 ODYSSEY RANDOMIZED TRIALS

Abstract

Background: The alirocumab (ALI) ODYSSEY clinical trial program recruited patients with hypercholesterolemia, ∼70% of whom had atherosclerotic cardiovascular disease (ASCVD) and were at very high ASCVD risk. This analysis evaluated the lipid-lowering efficacy and safety of ALI among patients with or without clinical ASCVD. Methods: The dataset originated from 4,983 patients with hypercholesterolemia randomized in 10 Phase 3 trials. Data were grouped into 4 pools based on ALI dose and control (placebo, Pools 1+2; ezetimibe, Pools 3+4) (Table). Patients in Pools 1–3 received background statins, which were at maximally tolerated dose in most patients (85%); patients in Pool 4 did not receive statins. Results: LDL-C % reductions from baseline and goal achievement at Week 24 were comparable in patients with or without clinical ASCVD in placebo-controlled trials (Table). LDL-C goal achievement was consistent in ALI-treated patients in ezetimibe-controlled trials. Treatment emergent adverse event (TEAE) rates and discontinuations due to TEAEs with ALI were similar to controls regardless of clinical ASCVD status (Table). Conclusions: Compared with controls, ALI administration substantially reduced LDL-C levels, allowed greater LDL-C goal achievement, and was generally well tolerated in both patients with and without clinical ASCVD.