On Nov. 15, 2019, Amgen in collaboration with the Duke Clinical Research Institute (DCRI) 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 was 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.

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. Lipid lowering is one of the key approaches for reducing a patient’s risk for secondary events. 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.

cvMOBIUS is a multicenter prospective observational registry in the U.S. and Canada. The study will be comprised of two parallel arms: a multicenter, prospective observational arm that will include 8,500 patients who experienced an ASCVD event within 12 months, from 250 sites; and a parallel EHR-based registry of a larger cohort of patients hospitalized with an ASCVD event treated at participating centers. The primary endpoint includes time to death, any non-fatal MI and any non-fatal ischemic stroke (IS).