Amgen(US:AMGN) Prnewswireยท2025-10-02 13:00Core Insights - The Phase 3 VESALIUS-CV clinical trial demonstrated that Repatha significantly reduces the risk of major adverse cardiovascular events (MACE) in high-risk patients without a prior history of heart attack or stroke, establishing it as the first and only PCSK9 inhibitor to show such results for both primary and secondary prevention [1][2][4]. Clinical Trial Details - The VESALIUS-CV trial enrolled over 12,000 high-risk patients, with approximately 85% on high-intensity or moderate LDL-C lowering therapy, and followed them for a median of about 4.5 years [1][8][9]. - The primary endpoints included the time to first occurrence of a composite of coronary heart disease (CHD) death, heart attack, or ischemic stroke, and the results were both statistically and clinically significant, with no new safety signals observed [3][4]. Implications for Cardiovascular Disease Management - The results highlight Repatha's potential as a cornerstone therapy in lipid management, particularly for patients at high cardiovascular risk who have not yet experienced a heart attack or stroke [4][10]. - Cardiovascular disease remains the leading cause of death globally, and high LDL-C is a modifiable risk factor; however, over 80% of high-risk patients without prior events were not at recommended LDL-C levels after one year of follow-up [2][5]. Regulatory and Market Context - Repatha has been used by over 6.7 million patients globally since its approval in 2015, and the FDA has broadened its approved use to include adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL-C [6][12]. - The full results from the VESALIUS-CV trial will be presented at the American Heart Association Scientific Sessions on November 8, and will be submitted for publication in a peer-reviewed journal [4].