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Amgen Presents Pooled Analysis Showing AMG 145 Significantly Reduced LDL Cholesterol In Over 1,200 Patients
Date:9/1/2013

AMG 145 treatment was also associated with improvements in other lipid parameters, including high-density lipoprotein cholesterol (HDL-C), triglycerides, apolipoprotein B, lipoprotein(a) and apolipoprotein A1, within each targeted dose frequency of AMG 145.

In the safety analysis, adverse events (AEs) were observed more frequently with AMG 145 than placebo (57 percent vs. 49 percent) with the most frequent AEs being nasopharyngitis (8.3 percent vs. 7.5 percent) and upper respiratory tract infection (4.1 percent vs. 3.3 percent). Serious AEs were 2.0 percent with AMG 145 and 1.2 percent with placebo. The rates of injection-site reactions were similar between patients treated with AMG 145 and those treated with placebo (4.1 percent vs. 3.3 percent) while muscle-related AEs and anti-drug binding antibodies were 6.0 percent vs. 3.9 percent and 0.1 percent vs. 0.3 percent, respectively.  

About the Pooled Analyses
The pre-specified, pooled analyses of data were from four Phase 2, placebo-controlled, randomized trials of AMG 145 in various patient populations with hyperlipidemia. In each trial, treatment duration was 12 weeks and the primary endpoint was percentage change in LDL-C from baseline, as measured by ultracentrifugation. Patients enrolled in the trials received various doses of AMG 145 subcutaneously every two weeks or monthly. Three of the four trials permitted stable background statin therapy. The trials included:

– MENDEL (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy for Easing Lipid Levels) evaluated the efficacy, safety and tolerability of AMG 145 administered subcutaneously every two weeks and every four weeks in hyperlipidemic patients (LDL-C ³ 100 mg/dL and < 190 mg/dL) who were not receiving statin therapy.

– LAPLACE-TIMI 57 (LDL-C Assessment with PCSK9 Monoclona'/>"/>

SOURCE Amgen
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