Evolocumab: Phase II data

The open-label, international Phase II OSLER extension trial in 1,104 patients with high cholesterol showed that once-monthly 420 mg subcutaneous evolocumab plus standard of care (SOC) led to a 52.3% mean reduction in LDL-C from baseline to week 52 in patients who were randomized to the control arm in a prior Phase II trial of evolocumab. In patients who received evolocumab in a prior Phase II trial, continued treatment with evolocumab plus SOC in OSLER led to a maintained LDL-C reduction from baseline to week 52 of 52.1%. The most common adverse events reported were nasopharyngitis, upper respiratory tract infection, influenza, arthralgia and back pain. Serious adverse events occurred in 7.1% of patients treated with evolocumab plus SOC vs. 6.3% of patients treated with SOC. OSLER enrolled patients who completed the Phase II RUTHERFORD, GAUSS, LAPLACE-TIMI 57 or MENDEL trials of evolocumab (see BioCentury, Nov. 12, 2012). Data were presented at the American Heart Association meeting in Dallas and published in Circulation. ...