Evolocumab Efficacious in Hypercholesterolemia Trial
Amgen announced results from its Phase 3 RUTHERFORD-2 trial evaluating evolocumab in combination with statins and other lipid-lowering therapies in patients with heterozygous familial hypercholesterolemia (HeFH). Evolocumab is a fully human monoclonal antibody that that is designed to bind to proprotein convertase subtilisin/kexin type 9 (PCSK9) proteins that target LDL receptors and inhibit PCSK9 from adhering to LDL receptors on the surface of the liver.
The RUTHERFORD-2 (RedUction of LDL-C with PCSK9 InhibiTion in HEteRozygous Familial HyperchOlesteRolemia Disorder Study-2) was a randomized, multicenter, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and efficacy of evolocumab in patients (n=329) HeFH and an LDL-C ≥100mg/dL who were on a stable dose of statin therapy and lipid-lowering medication. Patients were randomized to one of four treatment groups to compare subcutaneous evolocumab with subcutaneous placebo.
Evolocumab achieved its co-primary endpoints of percent reduction from baseline in LDL-C at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The mean percent reductions in LDL-C were consistent with the results observed for the same doses in the Phase 2 RUTHERFORD trial for evolocumab compared to placebo.
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