Amgen announced plans to conduct VESALIUS-CV, a multinational clinical outcomes study for Repatha® (evolocumab) which will involve at least 13,000 patients worldwide at high risk of experiencing a first cardiovascular (CV) event, despite optimized treatment with lipid-lowering therapy. The study will be the first to investigate long-term outcomes in this population with Repatha for a minimum of four years.
Conducted in collaboration with the Brigham and Women's Hospital Thrombolysis in Myocardial Infarction (TIMI) Study Group, patient enrollment for VESALIUS-CV is due to begin in the second quarter of 2019. The multicenter, double-blind, randomized, placebo-controlled, parallel-group outcomes study will include high-risk patients who have not yet had a heart attack or stroke, but have coronary, cerebrovascular or peripheral arterial disease, who may have had interventions, such as a coronary arterial bypass graft (CABG) or stents, or who may have diabetes with indicators of increased CVD risk.
"High cholesterol is the most important risk factor in coronary heart and vascular disease, but we know that recommended levels of LDL-C or 'bad' cholesterol are frequently not reached in very high-risk patients," said Robert Giugliano, M.D., principal investigator and a senior investigator at the TIMI Study Group at Brigham and Women's Hospital and Harvard Medical School. "The VESALIUS-CV study will explore the impact of evolocumab on major cardiovascular events, such as heart attack or stroke, in patients who are already receiving treatment for lipid lowering and cardiovascular disease, but remain at high-risk, allowing us to better understand the benefits of significant LDL-C lowering in multiple patient types."
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Amgen and TIMI previously collaborated on the Repatha cardiovascular outcomes study (FOURIER), which demonstrated Repatha's efficacy in reducing low-density lipoprotein cholesterol (LDL-C) levels, as well as the relative risk for major CV events in high-risk patients with a history of heart attack or stroke. VESALIUS-CV will build on these findings by exploring the potential benefit of Repatha in preventing a first heart attack or stroke in patients with some of the most significant risk factors for a first CV event.
VESALIUS-CV is part of Amgen's PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different pOpulations) program. This program of clinical studies investigates the impact of Repatha on CVD across multiple populations. To date, the PROFICIO program consists of 36 trials including more than 38,000 patients worldwide.
"PROFICIO represents our commitment to advancing the science of cardiovascular disease and improving the care of patients worldwide, and VESALIUS-CV is an important addition to this growing program," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "By continuing to invest in new scientific discovery through PROFICIO, we can help address some of the most significant unmet needs in patients at risk of life-changing cardiovascular events."
VESALIUS-CV is a Phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group outcomes study. At least 13,000 patients will be enrolled in the study globally, with at least 6,500 patients per treatment arm. Repatha (140 mg) or placebo will be self-administered subcutaneously every two weeks for a minimum of four years. Follow-up of all randomized patients is planned to continue for a minimum of four years and until a sufficient number of patients have experienced the composite endpoints. Two primary endpoints include time to coronary heart disease (CHD) death, myocardial infarction (MI), ischemic stroke (triple component); and time to CHD death, MI, ischemic stroke or any ischemia-driven arterial revascularization, whichever occurs first (quadruple component).