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Data From Phase 3 Pivotal Studies Show Amgen's Novel Investigational Cholesterol-Lowering Medication Evolocumab Significantly Reduced LDL Cholesterol In Statin Intolerant Patients And In Patients On Statins
THOUSAND OAKS, Calif.,
March 30, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced new detailed data from two Phase 3 pivotal studies that showed treatment with its novel investigational cholesterol-lowering medication, evolocumab (AMG 145), resulted in a statistically significant reduction in low-density lipoprotein cholesterol (LDL-C) between 37-39 percent, compared to ezetimibe in patients with high cholesterol who cannot tolerate statins (GAUSS-2) and between 55-76 percent compared to placebo when used in combination with statin therapy in patients with high cholesterol (LAPLACE-2). Results from the two separate Phase 3 studies, GAUSS-2 and LAPLACE-2, were presented today as Late-Breaking Clinical Trials and complement the three Phase 3 studies presented yesterday as Featured Clinical Research at the American College of Cardiology's 63
rd Annual Scientific Session (ACC.14). Positive results from the GAUSS-2 study were simultaneously published in the
Journal of the American College of Cardiology.
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Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.
In the GAUSS-2 study, the most common adverse events (AEs) (≥5 percent in the combined evolocumab group) were headache, myalgia, pain in extremity and muscle spasms. In the LAPLACE-2 study, no AEs occurred in ≥2 percent of the evolocumab combined group. The most common AEs in the evolocumab combined group (>1.5 percent) were back pain, arthralgia, headache, muscle spasms and pain in extremity.