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Amgen Announces Positive Top-Line Results From 52-Week Phase 3 DESCARTES Study Of Evolocumab (AMG 145) In Patients With High Cholesterol
Date:12/19/2013

in evolocumab) were nasopharyngitis, upper respiratory tract infection, influenza and back pain.

"Data from the Phase 3 DESCARTES study of evolocumab add to the promising safety and efficacy data we recently saw in the MENDEL-2 study and 52-week Phase 2 OSLER study," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These data contribute to the growing body of research suggesting that evolocumab may offer a new treatment option for patients with dyslipidemia."

Details of the DESCARTES study results will be submitted to a future medical conference and for publication.

According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C.2 Elevated LDL-C is recognized as a major risk factor for cardiovascular disease.3-4

DESCARTES Study Design
DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) is a Phase 3 randomized, multicenter, double-blind, placebo-controlled study designed to evaluate the long-term (52-week) safety, tolerability and efficacy of evolocumab in patients with hyperlipidemia at risk for cardiovascular disease. Background lipid-lowering therapy was optimized to one of four treatment groups (diet alone; diet plus atorvastatin 10 mg; diet plus atorvastatin 80 mg; and diet plus atorvastatin 80 mg plus ezetimibe 10 mg) for individual patients based on their LDL-C and cardiovascular risk according to the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III risk categories. After optimization, patients were maintained on therapy for at least four weeks. A total of 901 patients with a fasting LDL-C ≥ 75 mg/dL were then randomized and received monthly subcutaneous evolocumab 420 mg or placebo in combination with bac
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