Study Also Shows 36% Reduction in Risk of Heart Attack
Repatha is the First and Only PCSK9 Inhibitor to Significantly Reduce the Risk of First Heart Attack and Stroke
In this landmark study of more than 12,000 patients with atherosclerosis or diabetes who had no prior heart attack or stroke, Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE). Repatha also reduced the risk of heart attack by 36%. In a cohort of patients included in a lipid sub-study, the median achieved LDL-C was 45 mg/dL compared to 109 mg/dL in the placebo arm.
"The VESALIUS-CV results deliver clear and compelling evidence that intensive LDL-C lowering is critical to reducing cardiovascular risk," said
Repatha significantly reduced the risk of most secondary endpoints, including the following composites: heart attack, ischemic stroke or any ischemia-driven revascularization; CHD death, heart attack or revascularization; cardiovascular death, heart attack or ischemic stroke; and CHD death or heart attack. In addition, there were numerical trends for reduced mortality rates in the Repatha arm, including cardiovascular death (21% relative risk reduction), CHD death (11% relative risk reduction) and all-cause death (20% relative risk reduction), as well as a trend toward lower ischemic stroke (21% relative risk reduction).
"Building on the success of FOURIER, in which we showed that adding evolocumab to statin therapy in patients with a prior heart attack or stroke reduced the risk of subsequent major adverse cardiovascular events, we now show that in the much larger population of patients with atherosclerosis or diabetes, but without a prior heart attack or stroke, that adding evolocumab to their lipid regimen substantially reduces their risk of MACE," said
Results also showed reduction in risk of cardiovascular events in the nearly 60% of trial participants who had diabetes, reinforcing the urgent need to manage LDL-C in these patients who remain largely undertreated.
"Cardiovascular disease remains the leading cause of mortality and morbidity for people living with diabetes, driven by risk factors including high LDL-C. Reducing this risk needs to be prioritized in primary care settings where the majority of people living with diabetes receive care," said Osagie Ebekozien M.D., M.P.H., CPHQ, Chief Quality Officer,
No new safety signals were identified, and tolerability was consistent with the current prescribing information in the
Cardiovascular disease is the leading cause of death worldwide.1 Every 40 seconds, a heart attack or stroke occurs in the
Repatha was first approved in 2015 and has since been used by more than 6.7 million patients globally.3,4 Earlier this year, the
About the VESALIUS-CV Trial
VESALIUS-CV is a Phase 3, double-blind, randomized, placebo-controlled global clinical trial designed to evaluate the impact of LDL-C lowering with evolocumab on MACE in adults at high CV risk without prior heart attack or stroke.
VESALIUS-CV enrolled more than 12,000 patients with known atherosclerotic cardiovascular disease (ASCVD) or high-risk diabetes, who 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; and treated with highest tolerated dose of statin and/or ezetimibe. The median baseline LDL-C was 122 mg/dL (IQR, 104-149 mg/dL) on local lab testing. Participants were randomized to receive Repatha or placebo in addition to optimized lipid-lowering therapy and were followed for a median of approximately 4.6 years.
Cardiovascular disease (CVD) remains a major global health threat, linked to multiple interrelated risk factors like high LDL-C, Lp(a), obesity, diabetes and hypertension.5,6 These risks often coexist and require a comprehensive approach to prevention and care.
About Repatha
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
Repatha is the most extensively studied PCSK9 inhibitor, with clinical and real-world evidence across diverse populations and CV risk profiles.7 The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients.8 Repatha is approved in 74 countries, including the
INDICATIONS
Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor indicated:
The safety and effectiveness of Repatha® have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hypercholesterolemia. For full prescribing information, visit www.Repatha.com.
IMPORTANT SAFETY INFORMATION
Please see full Prescribing Information.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube and Threads.
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