Abstract 15710: Impact of Age on the Efficacy and Safety of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia

2017 
Background: Individuals with heterozygous familial hypercholesterolemia (HeFH) often require additional LDL-C lowering beyond that achieved with statins. The PCSK9 inhibitor alirocumab (ALI) was shown in Phase 3 trials to reduce LDL-C in patients treated with maximally tolerated doses of statins. However, it is unknown if age impacts on the effects of ALI in patients with HeFH. Purpose: This post-hoc analysis examined impact of age on efficacy and safety of ALI in patients with HeFH, using pooled data from four 78-week ODYSSEY Phase 3 trials. Methods: Data from 1257 patients with HeFH on maximally tolerated statin ± other lipid-lowering therapies were analyzed. In FH I & II, patients received placebo (PBO) or ALI 75 mg SC every two weeks (Q2W), with dose increase to 150 mg Q2W at Week (W) 12 if W8 LDL-C was ≥70 mg/dL. In HIGH FH and LONG TERM, patients received PBO or ALI 150 mg Q2W. For efficacy analyses, data were pooled by initial ALI dose (75 or 150 mg). Efficacy and safety were assessed in patient su...
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