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.
"We now have additional evidence of the benefit of evolocumab in reducing cardiovascular event risk, even in patients starting with LDL-C levels below the most aggressive current guideline targets and in patients already on maximum-intensity statin therapy," Marc S. Sabatine, M.D., M.P.H., chairman of the TIMI Study Group, the Lewis Dexter, MD, Distinguished Chair in Cardiovascular Medicine at Brigham and Women's Hospital, and Professor of Medicine, Harvard Medical School, Boston said.
The two analyses compared clinical outcomes in patients stratified by baseline LDL-C above and below 70 mg/dL and in patients on maximum-intensity statin therapy, defined as atorvastatin 80 mg or rosuvastatin 40 mg daily, versus patients on less intense 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 <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).
In patients on maximum-intensity statins (n=7,533), Repatha reduced the median baseline LDL-C from 93 mg/dL to 32 mg/dL. Additionally, Repatha consistently reduced the risk of major cardiovascular events in patients on maximum-intensity and less intense statin therapy in both the composite primary endpoint (14 percent in patients on maximum-intensity statin therapy; 15 percent in patients on less intense statin therapy, P-interaction=0.88) and the composite secondary endpoint (22 percent in patients on maximum-intensity statin therapy; 19 percent in patients on less intense statin therapy, P-interaction=0.71).
In the two analyses, there were no differences in the rates of adverse events leading to discontinuation between treatment groups in patients who had a baseline LDL-C below 70 mg/dL (4.4 percent Repatha; 4.6 percent placebo) or in patients on maximum-intensity statin therapy (3.9 percent Repatha; 3.7 percent placebo).