Alirocumab: Phase II data

A double-blind, Japanese Phase II trial in 100 patients with LDL-C >=100 mg/dL on stable lipid-lowering therapy showed that 50, 75 or 150 mg subcutaneous alirocumab given every other week in combination with statin therapy each met the primary endpoint of a greater mean percent reduction in LDL-C from baseline to week 12 vs. placebo (55%, 62% and 72%, respectively, vs. 3%, p<0.0001 for all). Additionally, 100% of patients receiving alirocumab achieved an LDL-C of <100 mg/dL vs. 8% for placebo. The most commonly reported treatment-emergent adverse events were nasopharyngitis, injection-site reaction, back pain, cystitis and ligament sprain. ...