ODYSSEY COMBO II Trial Summary: Alirocumab in High CV risk Patients with Hypercholesterolemia

odyssey combo 2 trial

2015 ODYSSEY COMBO II TRIAL Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia double-blind, double-dummy, placebo controlled, parallel, randomized controlled trial Objective: To assess the efficacy & safety of alirocumab compared with therapy to maximally tolerated statin therapy in high CV risk patients with inadequately controlled hypercholesterolaemia 720 patients Inclusion criteria: Patients ≥18 years (1) with high CV risk (2) on maximum tolerated statin therapy (3) low-density lipoprotein cholesterol (LDL-C) >70 mg/dl with h/o CV disease, or LDL-C >100 mg/dl with no h/o cardiovascular disease HOW VS Alirocumab group (n=479) Ezetimibe group (n=241) -50.6 PRIMARY OUTCOME Change in LDL-C at week 24 Diff -29.8; 95% CI, -34.4 to -25.3; P <0.0001 SECONDARY OUTCOMES -20.7 71.2 Any treatment-emergent adverse events% 67.2 4.8 Cardiovascular events % 3.7 Conclusion: In patients at high cardiovascular risk with inadequately controlled LDL-C, alirocumab achieved significantly greater reductions in LDL-C compared with ezetimibe, with a similar safety profile. CP Cannon et al. Eur Heart J. 2015;36(19):1186-1194