Amgen has revealed results of Repatha (evolocumab) cardiovascular outcomes study, FOURIER, revealing that the
drug is capable of significantly reducing risk of adverse cardiovascular events.
The drug targets the low-density lipoprotein cholesterol (LDL-C) and reduces it and according to Amgen, it is has been established for the first time through a trial involving 27,564 patients that reducing LDL-C levels through Repatha leads to a further reduction in major cardiovascular events, including heart attacks, strokes and coronary revascularizations.
As Amgen reveals, the study was statistically powered around the hard major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke or cardiovascular death. Findings indicate adding Repatha to optimized statin therapy resulted in a statistically significant 20 percent reduction in these events. The robust benefit in this objective measure started as early as six months and continued to accrue through the median 2.2 years of the study. In fact, the magnitude of the risk reduction in the hard MACE composite endpoint grew over time, from 16 percent in the first year to 25 percent beyond the first year.
There was also a statistically significant 15 per cent reduction in the risk of the extended MACE composite endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death.
Patients who were given Repatha experienced a 27 per cent reduction in the risk of heart attack, 21 per cent reduction in stroke and 22 per cent reduction in coronary revascularization.
“We now show for the first time in a dedicated outcomes study that decreasing LDL cholesterol with PCSK9 inhibition results in clinically meaningful cardiovascular benefit,” said 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.