US biopharmaceutical company Amgen (NASDAQ:AMGN) announced on Saturday that Repatha (evolocumab), when added to statins or other low-density lipoprotein cholesterol (LDL-C)-lowering treatments, reduced the risk of first major adverse cardiovascular (CV) events (MACE) in high-risk primary prevention patients without known significant atherosclerosis (buildup of plaque in the arteries) and with diabetes.
The findings were presented in a late-breaking session at the American College of Cardiology (ACC) 75th Annual Scientific Session and simultaneously published in the Journal of the American Medical Association.
The results are from a new subgroup analysis of 3,655 patients at increased risk of CV events without known significant atherosclerosis (all of whom had diabetes) followed for a median of 4.8 years from the Phase 3 VESALIUS-CV clinical trial. According to Amgen, the results showed Repatha reduced the risk of the composite primary endpoint of coronary heart disease (CHD) death, myocardial infarction or ischemic stroke (3-P MACE) by 31% compared with placebo. Repatha also reduced the risk of a dual composite primary endpoint that included ischemia-driven revascularisation (4-P MACE) by 31%. The median achieved LDL-C was 44 mg/dL at 96 weeks in the Repatha added to optimised lipid-lowering therapy arm compared to 105 mg/dL in the placebo plus optimised lipid-lowering therapy arm (548 patients in the subgroup were part of a lipid sub-study).
"The evidence is unequivocal: Intensive LDL-C lowering with Repatha significantly reduces the risk of major CV events for high-risk patients," said Jay Bradner, M.D., Amgen executive vice president of Research and Development.
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