First-of-its-kind real-world study to assess effectiveness of PCSK9 inhibitors
Amgen (CA, USA) and the Duke Clinical Research Institute (NC, USA) have jointly announced plans to carry out the largest, registry-based, real-world study investigating the clinical effectiveness of PCSK9 inhibitors for the prevention of secondary cardiovascular events.
Amgen (CA, USA) and the Duke Clinical Research Institute (NC, USA) have jointly announced plans to initiate their Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 inhibitors (cvMOBIUS) study. This represents the largest, prospective, real-world study – including 8500 study participants who have recently experienced a cardiovascular disease-related health event – investigating the clinical effectiveness of PCSK9 inhibitors for the prevention of secondary cardiovascular events.
Individuals who have recently experienced an atherosclerotic cardiovascular disease-related event – for example, a myocardial infarction – face increased risks of experiencing secondary such events, particularly within the year following the first event. Interventions that act to lower individuals' levels of circulating lipids represent one of the main therapeutic approaches for the prevention of these secondary cardiovascular events.
The cvMOBIUS study seeks to provide real-world support for the strong evidence already obtained from multiple randomized controlled trials demonstrating the efficacy of PCSK9 inhibitors for improving cardiovascular outcomes.
The trial will comprise two parts: 8500 patients across the USA and Canada, who are eligible for the receipt of a PCSK9 inhibitor, will be monitored for 5 years. At the same time, a parallel investigation of the electronic health records of a much larger population of patients, who have been hospitalized for atherosclerotic cardiovascular disease, will be undertaken.
Ann Marie Navar (Duke University School of Medicine; NC, USA) explained: “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.”
Navar continued: “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.”
Eric D. Peterson (Duke University School of Medicine) commented: “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.”
Navar and Peterson are to be co-primary investigators of the study, which will begin participant enrolment this month.