PCSK9 Inhibitor Shows Promise

Amgen’s monoclonal antibody evolocumab (formerly called AMG 145) did well at inhibiting proprotein convertase subtilisin/kexin 9 (PCSK9) and reducing LDL cholesterol in a group of older patients, a Florida team reports.

In a poster to be presented Saturday, March 14, at the American College of Cardiology meeting in San Diego, Michael Koren, MD, of the Jacksonville Center for Clinical Research said the drug worked well in a group of patients over 65 who were enrolled in phase 2 and phase 3 studies of evolocumab. The drug did better than placebo or ezetimibe (Zetia/Merck) the efficacy was similar in patients age 65 to 75 and in patients over age 75.

Researchers assessed efficacy using data from 958 patients in four phase-3 studies. The safety analysis came from phase-2 and phase-3 studies and their open label extension studies (1,179 patients).

Most adverse events were mild and no notable imbalances were observed between control and evolocumab in either age group, including no differences in myalgia or neurocognitive events.

The researchers concluded that evolocumab “potently reduced LDL-C” patients age 65 to 75 and in patients over age 75 with a side effect profile similar to that of placebo.