LANDMARK PHASE 3 TRIAL (VESALIUS-CV) MEETS PRIMARY ENDPOINTS IN A CARDIOVASCULAR PRIMARY PREVENTION STUDY OF 12,000 PATIENTS

https://www.prnewswire.com/news-releases/landmark-phase-3-trial-vesalius-cv-meets-primary-endpoints-in-a-cardiovascular-primary-prevention-study-of-12-000-patients-302573412.html?tc=eml_cleartime Repatha® Trial Demonstrates Breakthrough in Preventing First Cardiovascular Events On October 2nd, Amgen announced that the Phase 3 VESALIUS-CV clinical trial had met its dual primary endpoints, demonstrating that their PCSK9 inhibitor, Repatha®, when added to statins or other LDL-cholesterol–lowering therapy, significantly reduced the risk of major cardiovascular events (MACE) in high-risk adults without a history of heart attack or stroke. The trial enrolled over 12,000 high-risk patients and followed them for a median of approximately 4.5 years. These results mark the first time a PCSK9 inhibitor has shown benefit not only in patients with prior cardiovascular events, but also in a prevention setting for those without a history of heart attack or stroke. Amgen plans to formally present the results at the American Heart Association (AHA) Scientific Sessions on November 8th and submit for publication in a peer-reviewed journal. For our community, this is an important step forward in expanding the role of aggressive LDL-C lowering earlier in higher-risk patients before a first event occurs.