Phase III FOURIER study of Repatha (evolocumab) shows effectiveness in reducing cardiovascular events- Amgen

Amgen announced new data from the Repatha (evolocumab) cardiovascular outcomes trial (FOURIER), which showed that Repatha consistently and safely reduced cardiovascular events in patients with established cardiovascular disease regardless of baseline low-density lipoprotein cholesterol (LDL-C) level below or above 70 mg/dL. A separate analysis also demonstrated Repatha reduced cardiovascular events in patients being treated with maximum-intensity statin therapy.

In patients with a baseline LDL-C below 70 mg/dL (n=2,034), Repatha reduced the median baseline LDL-C from 65.5 mg/dL to 21.0 mg/dL. Repatha consistently reduced the risk of the composite primary endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death, regardless of whether baseline LDL-C was below or above 70 mg/dL (20 percent in patients with baseline below 70 mg/dL; 14 percent in patients with baseline =70 mg/dL, P-interaction=0.65). The results were also consistent for the more robust, secondary composite endpoint of heart attack, stroke or cardiovascular death where patients with a baseline LDL-C less than 70 mg/dL experienced a 30 percent reduction in cardiovascular events and patients with a baseline LDL-C greater than or equal to 70 mg/dL experienced a 19 percent reduction in cardiovascular events (P-interaction=0.44). These results were presented during a late-breaker session at the 2017 National Lipid Association Scientific Sessions.