1. % decrease in LDL-C at 24 weeks from baseline
ODYSSEY HIGH FH
Trial design: Patients with heterozygous familial hypercholesterolemia (HeFH) on maximal statin dose with LDL ≥160 mg/dl were randomized in a 2:1 fashion to either self-administered alirocumab 150 mg SC Q2W or placebo. They were followed for 24 weeks.
Results
(p < )
% decrease in LDL-C levels at 24 weeks from baseline for alirocumab vs. placebo: 45.7% vs. 6.6%, difference 39.1, p <
Absolute ↓ in LDL from baseline: 107 vs. 182 mg/dl
LDL-C <100 mg/dl: 57% vs. 11%, p <
CV events: 8.3% vs. 0% %
Conclusions
Alirocumab is superior to placebo in lowering LDL-C levels and achieving target levels in HeFH 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 = 72)
Placebo
(n = 35)
Presented by Dr. Henry Ginsberg at AHA 2014