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Trial of a PCSK9 inhibitor in heterozygous familial hypercholesterolemia

Trial of a PCSK9 inhibitor in heterozygous familial hypercholesterolemia

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Rutherford slide Rutherford slide Presentation Transcript

  • Reduction of LDL-C with PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD): Interim Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial• Background: Heterozygous familial • Results: At week 12, percent change in LDL-C levels hypercholesterolemia (HeFH) is a common genetic were -43% in the 350 mg AMG145 group, -55% in the disorder that causes many patients not to reach LDL-C 420 mg AMG145 group and an increase of 1% in the treatment goals, even with statin therapy. Plasma placebo group. No serious treatment-related adverse proprotein convertase subtilisin/kexin type 9 (PCSK9) events occurred. binds LDL receptors, therefore increasing levels of LDL- • Conclusion: AMG145 may provide effective additional C in the blood. Phase 1 studies of a human monoclonal LDL-C lowering treatment in HeFH patients on intensive antibody to PCSK9, AMG145, have shown tolerance statin therapy. and effectiveness in lowering LDL-C.• Purpose: To assess the effectiveness and safety of Percent of Patients Treated to LDL-C Goal at Week 12 AMG145 in patients with HeFH. Treatment LDL-C < 100 LDL-C < 70• Methods: In this 12-week, randomized, double-blind, mg/dL mg/dL placebo-controlled study, 167 patients were 350 mg AMG145 70% 44% randomized to one of 3 treatments: 350 mg of AMG145, 420 mg of AMG145 or placebo administered 420 mg AMG145 89% 65% subcutaneously every 4 weeks. Primary endpoint was percent change in LDL-C levels from baseline to 12 Placebo 2% 0% weeks. Presented by: Raal F, AHA Scientific Sessions, Los Angeles © 2012, American Heart Association. All rights reserved.