THOUSAND OAKS, Calif.
Dec. 19, 2013
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Phase 3 DESCARTES (
ffect of PC
tudy) study evaluating the long-term 52-week safety and efficacy of evolocumab for the treatment of high cholesterol met its primary endpoint of percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 52. The mean percent reduction in LDL-C, or "bad" cholesterol, was consistent with the results observed in the 52-week analysis of the Phase 2 OSLER (
m Evaluation Against LDL-C) study.
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.
The DESCARTES study evaluated safety, tolerability and efficacy in 901 patients with high LDL-C and a range of cardiovascular risk. 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. Patients with a fasting LDL-C ≥ 75 mg/dL were then randomized to receive monthly subcutaneous evolocumab 420 mg or placebo in combination with background lipid-lowering therapy.
Evolocumab significantly reduced LDL-C, as measured by the accepted standard, preparative ultracentrifugation, from baseline at week 52 compared to placebo. LDL-C reduction at week 12 was consistent with the long-term efficacy at week 52.
Safety was balanced across treatment groups. The most common adverse events (> 5 percent in evolocumab) were nasopharyngitis, upper respiratory tract infection, influenza and back pain.