Bococizumab: Phase IIb data

A 24-week, double-blind, U.S. Phase IIb trial in 354 patients with an LDL-C of >=80 mg/dL on background treatment with a statin showed that all doses of subcutaneous bococizumab - once monthly at 200 or 300 mg and twice monthly at 50, 100 or 150 mg - met the primary endpoint of reducing LDL-C from baseline to week 12 vs. placebo. The greatest reductions in mean LDL-C from baseline to week 12 were reported at the once-monthly 300 mg bococizumab and twice-monthly 150 mg bococizumab arms (placebo-adjusted reductions of 44.9 and 53.4 mg/dL, respectively). Maximum reductions in mean LDL-C from baseline were achieved at week 4 in the once-monthly 300 mg bococizumab arm (placebo-adjusted reduction of 54.9 mg/dL) and at week 8 in the twice-monthly 150 mg bococizumab arm (placebo-adjusted reduction of 66.9 mg/dL). The proportion of patients reporting adverse events or serious adverse events was similar across all treatment arms. Patients received a dose reduction of bococizumab at week 8 in the once-monthly regimens and at week 6 in the twice-monthly regimens if they achieved an LDL-C reduction to <=25 mg/dL. Data were presented at the American College of Cardiology meeting in Washington, D.C. ...