BioCentury
ARTICLE | Clinical News

Evolocumab: Phase III data

December 23, 2013 8:00 AM UTC

Top-line data from the double-blind, international Phase III DESCARTES trial in 901 patients with fasting LDL-C levels of >=75 mg/dL and fasting triglycerides of <=400 mg/dL showed that once-monthly 420 mg subcutaneous evolocumab in combination with patients' background lipid-lowering therapy met the primary endpoint of a greater percent reduction in LDL-C from baseline to week 52 vs. placebo. Amgen said the 52-week percent LDL-C reduction seen in DESCARTES was consistent with the 52-week reduction seen in the Phase II OSLER trial to treat hypercholesterolemia. In November, Amgen reported data from OSLER showing that once-monthly evolocumab led to a 52% mean reduction in LDL-C from baseline to week 52. Additionally, Amgen said the percent LDL-C reduction in DESCARTES from baseline to week 12, a secondary endpoint, was consistent with the reduction at week 52. The most common adverse events reported were nasopharyngitis, upper respiratory tract infection, influenza and back pain. Patients' background lipid-lowering therapies included diet alone, diet plus atorvastatin and diet plus atorvastatin and ezetimibe. ...