Amgen announced that evolocumab reduced the risk of MACEs such as heart attack and stroke in patients without any prior history of these events.
The phase 3 VESALIUS-CV trial has achieved its dual primary endpoints, demonstrating a significant reduction in major adverse cardiovascular event (MACE) risk due to evolocumab (Repatha) in patients with atherosclerotic cardiovascular disease (ASCVD) and no prior history of heart attack or stroke.1
Announced by Amgen on October 2, 2025, VESALIUS-CV met the endpoints of time to first occurrence of a composite of heart attack, ischemic stroke, and coronary heart disease (CHD) death, as well as time to first occurrence of a composite of CHD death, ischemic stroke, heart attack, or any ischemia-driven arterial revascularization. Both endpoints were clinically and statistically significant, and no new safety signals were observed.1
“These results mark an important milestone in the fight against cardiovascular disease, the leading cause of death worldwide,” Jay Bradner, MD, executive vice president of research and development at Amgen, said in a statement. “The benefit across all endpoints and established safety profile underscore Repatha’s role as a cornerstone therapy in comprehensive lipid management.”1
The double-blind, randomized, placebo-controlled VESALIUS-CV trial enrolled >12,000 adult patients with known ASCVD or high-risk diabetes. The trial was begun after the 2017 FOURIER study proved the association between evolocumab and a reduction of MACEs in patients with established ASCVD and a history of MACEs, such as heart attack or stroke.1
All participants had no history of heart attack or stroke, an LDL-C ≥90 mg/dL, or non-high-density lipoprotein cholesterol (non-HDL-C) ≥120 mg/dL, or apolipoprotein B ≥80 mg/dL. Participants were randomly assigned to receive either evolocumab or placebo, along with optimized lipid-lowering therapy, and were followed for an approximate median of 4.5 years.
Announced by Amgen on October 2, 2025, VESALIUS-CV met the endpoints of time to first occurrence of a composite of heart attack, ischemic stroke, and coronary heart disease (CHD) death, as well as time to first occurrence of a composite of CHD death, ischemic stroke, heart attack, or any ischemia-driven arterial revascularization. Both endpoints were clinically and statistically significant, and no new safety signals were observed.1
“These results mark an important milestone in the fight against cardiovascular disease, the leading cause of death worldwide,” Jay Bradner, MD, executive vice president of research and development at Amgen, said in a statement. “The benefit across all endpoints and established safety profile underscore Repatha’s role as a cornerstone therapy in comprehensive lipid management.”1
The double-blind, randomized, placebo-controlled VESALIUS-CV trial enrolled >12,000 adult patients with known ASCVD or high-risk diabetes. The trial was begun after the 2017 FOURIER study proved the association between evolocumab and a reduction of MACEs in patients with established ASCVD and a history of MACEs, such as heart attack or stroke.1
All participants had no history of heart attack or stroke, an LDL-C ≥90 mg/dL, or non-high-density lipoprotein cholesterol (non-HDL-C) ≥120 mg/dL, or apolipoprotein B ≥80 mg/dL. Participants were randomly assigned to receive either evolocumab or placebo, along with optimized lipid-lowering therapy, and were followed for an approximate median of 4.5 years.
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