Evolocumab: Additional Phase III data

Additional data from the double-blind, international Phase III DESCARTES trial in 901 patients with fasting LDL-C 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 led to a placebo-adjusted mean percent reduction in LDL-C from baseline to week 52, the primary endpoint, of 57%. Specifically, evolocumab led to placebo-adjusted mean percent reductions in LDL-C from baseline to week 52 of 56% in patients who underwent background therapy with diet alone, 62% in patients who received diet plus 10 mg atorvastatin, 57% in patients who received diet plus 80 mg atorvastatin and 49% in patients who received diet plus 80 mg atorvastatin and 10 mg ezetimibe (p<0.001 for all). There was 1 neurocognitive adverse event of amnesia in a patient receiving evolocumab in DESCARTES vs. 2 neurocognitive adverse events of dementia with Lewy bodies and encephalopathy in 2 patients receiving placebo. Data were published in the New England Journal of Medicine and presented at the American College of Cardiology meeting in Washington, D.C. In December, Amgen reported top-line data from DESCARTES showing that evolocumab met the primary endpoint (see BioCentury, Dec. 23, 2013). ...