DCRI to Partner With Amgen on Large-Scale Registry

November 15, 2019 – By enrolling 8,500 high-risk patients with a recent atherosclerotic cardiovascular disease event, cvMOBIUS will be the first large-scale registry to evaluate real-world lipid management and the effectiveness of PCSK9 inhibitors.

Amgen (NASDAQ:AMGN) in collaboration with the Duke Clinical Research Institute (DCRI) today announced plans to initiate the Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 inhibitors (cvMOBIUS) study—the first large-scale real-world study to assess lipid management and the impact of PCSK9 inhibitors on cardiovascular (CV) outcomes in clinical practice. While there is strong evidence demonstrating the efficacy of PCSK9 inhibitors from various randomized clinical trial studies, there is less information on the effectiveness of these medicines on cardiovascular outcomes in real-world practice.

The cvMOBIUS study will be conducted across the U.S. and Canada and will begin patient enrollment this month. A prospective observational registry of 8,500 adults eligible for treatment with a PCSK9 inhibitor will be followed for five years. In parallel, an electronic health record (EHR)-based registry will follow a broader population of adults hospitalized with atherosclerotic cardiovascular disease (ASCVD) at participating sites.

Ann Marie Navar, MD, PhD“Cardiovascular disease is one of the most significant public health issues facing our country today. Gathering robust, large-scale data from diverse patients will better inform lipid management and help decrease the burden of cardiovascular disease in these high-risk patients,” said Ann Marie Navar, M.D., Ph.D., assistant professor of medicine at the Duke University School of Medicine and member of the DCRI. “The clinical evidence supporting the efficacy and safety of PCSK9 inhibitors in patients with cardiovascular disease is well established, but we still have a lot to learn about the benefits of these medicines in the real world.”

Patients who have experienced a recent ASCVD event, including a myocardial infarction (MI), are at higher risk of experiencing another CV event, especially within the first year after.1,2 Lipid lowering is one of the key approaches for reducing a patient’s risk for secondary events.1 Based on large randomized trials, major professional cardiology societies, including the American Heart Association and the American College of Cardiology, acknowledge that lower is better when it comes to low density lipoprotein cholesterol (LDL-C) management in patients who have experienced an MI and other ASCVD events.3

“LDL-C is one of the most important modifiable risk factors for cardiovascular disease, so lipid Eric Peterson, MD, MPHmanagement is an essential element in reducing future CV events and improving clinical outcomes for high-risk patients,” said Eric D. Peterson, M.D., MPH, distinguished professor of medicine at the Duke University School of Medicine and member of the DCRI. “This large registry will examine how care is being delivered in clinical practice to patients—whether we are using the right medicines, whether we are reaching guideline-based LDL-C targets, and the degree to which achieving these goals impacts outcomes in real-world practice.”

“The cvMOBIUS study is important because it is one of the few instances that researchers will utilize data pulled directly from hospitals’ EHR systems for research. This should help set the stage for future big data analyses and pragmatic clinical trials,” said Dr. Peterson.

Two large randomized outcomes trials, including the Repatha® (evolocumab) cardiovascular outcomes (FOURIER) study, have demonstrated that innovative therapies like PCSK9 inhibitors lower LDL-C levels and can reduce the risk of heart attacks in high-risk patients with established cardiovascular disease. Additionally, the VESALIUS-CV trial, initiated in March 2019, is an ongoing randomized outcomes trial, designed to evaluate the long-term effects of Repatha in high-risk cardiovascular disease (CVD) patients without a prior heart attack or stroke. The study will be the first to investigate long-term outcomes in this population with Repatha for a minimum of four years.

“Amgen is committed to building a vast body of evidence for Repatha—clinical trial and real-world effectiveness data sets—to advance the knowledge and treatment of cardiovascular disease,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “This study will generate valuable real-world evidence to help us demonstrate that PCSK9 inhibitors, like Repatha, are an important treatment option for very high-risk patients and can help prevent recurrent cardiovascular events in the real world.”

Drs. Navar and Peterson are co-primary investigators of the study.

References   

  1. Yusuf S, et al. Lancet. 2004;364:937-952. 5. Ference BA, et al. EHJ. 2017;38:2459-2472.
  2. Kuklina, EV. Centers for Disease Control and Prevention. Vital signs: prevalence, treatment, and control of high levels of low-density lipoprotein cholesterol. United States, 1999–2002 and 2005–2008. MMWR. 2011;60(4):109–14.
  3. Grundy SM, et al. JACC. 2018; 1-80.
  4. Repatha Prescribing Information; Amgen, Thousand Oaks, CA, 2018.
  5. World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.