Effect of Alirocumab on Lipoprotein(a) Over ≥1.5 Years (From the Phase 3 ODYSSEY Program)

Abstract Elevated lipoprotein(a) [Lp(a)] is independently associated with increased cardiovascular risk. However, treatment options for elevated Lp(a) are limited. Alirocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9, reduced low-density lipoprotein cholesterol (LDL-C) by up to 62% from baseline in Phase 3 studies, with adverse event rates similar between alirocumab and controls. We evaluated the effect of alirocumab on serum Lp(a) using pooled data from the Phase 3 ODYSSEY program: 4915 patients with hypercholesterolemia from 10 Phase 3 studies were included. Eight studies evaluated alirocumab 75 mg every 2 weeks (Q2W), with possible increase to 150 mg Q2W at Week 12 depending on LDL-C at Week 8 (75/150 mg Q2W); the other 2 studies evaluated alirocumab 150 mg Q2W from the outset. Comparators were placebo or ezetimibe. Eight studies were conducted on a background of statins and 2 studies were carried out with no statins. Alirocumab was associated with significant reductions in Lp(a), regardless of starting dose and use of concomitant statins. At Week 24, reductions from baseline were 23–27% with alirocumab 75/150 mg Q2W and 29% with alirocumab 150 mg Q2W (all comparisons P