Phase III study of Repatha (evolocumab) shows efficacy in patients with high cholesterol- Amgen

Amgen has announced new detailed data from the Phase III GAUSS-3 trial evaluating Repatha (evolocumab) in patients with high cholesterol who cannot tolerate statins. The study showed that in patients with reproducible statin intolerance due to muscle-related side effects (MRSE), the use of Repatha compared to ezetimibe resulted in a significantly greater reduction in low-density lipoprotein cholesterol (LDL-C) after 24 weeks. Data from prespecified co-primary endpoints showed the mean LDL-C reduction from baseline at weeks 22 and 24 was 54.5 percent for Repatha compared to 16.7 percent for ezetimibe.

At week 24, LDL-C reduction was 52.8 percent for Repatha compared to 16.7 percent for ezetimibe. At baseline, the mean LDL-C level was 219.9 mg/dL for all patients entering the active-controlled part of the trial. Muscle-related side effects were reported in 20.7 percent of Repatha patients and 28.8 percent of ezetimibe patients. In patients treated with ezetimibe, active study drug was stopped for muscle symptoms in 6.8 percent of patients, compared to 0.7 percent of patients treated with Repatha. These data were presented at the American College of Cardiology's 65th Annual Scientific Session and simultaneously published in the Journal of the American Medical Association.