Alirocumab: Additional Phase III data

Additional data from the double-blind, international Phase III ODYSSEY LONG TERM safety trial in 2,341 patients with hypercholesterolemia and high cardiovascular risk who were not adequately controlled with lipid-lowering therapy showed that 150 mg subcutaneous alirocumab every 2 weeks reduced LDL-C from baseline to week 24, the primary efficacy endpoint, by 61% vs. a 1% increase for placebo (p<0.0001). At week 52, alirocumab reduced LDL-C from baseline by 57% vs. a 4% increase for placebo (p<0.0001). Additionally, a greater proportion of patients receiving alirocumab achieved a pre-specified LDL-C goal (either 70 or 100 mg/dL depending on baseline cardiovascular risk) at week 24 vs. placebo (81% vs. 9%, p<0.0001). A post hoc safety analysis showed a significantly lower rate of adjudicated major cardiovascular events in the alirocumab arm compared to the placebo arm (1.4% vs. 3%, p<0.01). Data were presented at the European Society of Cardiology meeting in Barcelona. In July, the partners reported that the trial met its primary efficacy endpoint (see BioCentury, Aug. 4). ...