1. % decrease in LDL-C at 24 weeks from baseline
ODYSSEY COMBO I
Trial design: Patients with suboptimal LDL-C control despite being on maximal tolerated doses of a statin were randomized in a 2:1 fashion to either self-administered alirocumab 75 mg SC Q2W or matching placebo. They were followed for 24 weeks.
Results
(p < )
% decrease in LDL-C levels at 24 weeks from baseline for alirocumab vs. placebo: 48.2% vs. 2.3%, difference 45.9%, p <
Absolute ↓ in LDL from baseline: 51.4 vs mg/dl
LDL-C <70 mg/dl: 75% vs. 9%, p <
CV events: 2.9% vs. 2.8% %
Conclusions
Alirocumab is superior to placebo in lowering LDL-C levels and achieving target levels in high CV risk patients already on maximal tolerated doses of statins (with or without other lipid-lowering therapy)
Trial adds to the growing body of literature with PCSK9 inhibitors
% decrease in LDL-C at 24 weeks from baseline
Alirocumab
(n = 209)
Placebo
(n = 107)
Presented by Dr. Dean Kereiakes at AHA 2014