FOURIER trial results: Evolocumab significantly reduces CV event risk
Recently announced results from the FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial show that treatment with the PCSK9 inhibitor evolocumab significantly reduced the risk of cardiovascular events in patients with clinical atherosclerotic cardiovascular disease on optimized statin therapy.
The trial showed significant reduction in both its primary endpoint (a composite of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or coronary revascularization) as well as the key secondary endpoint (a composite of cardiovascular death, non-fatal MI or non-fatal stroke). Importantly, no new safety issues were observed.
Professor Henry Ginsberg (Columbia University, New York, USA) said, “While we eagerly await the full report from the study, it is exciting to see that this very large and rigorously performed trial met both of its goals: to achieve lower rates of cardiovascular events in patients on statin plus evolocumab versus statin alone and to have no adverse effects of evolocumab on cognitive function. This is very good news for patients with cardiovascular disease who remain at high risk despite having reduced their LDL cholesterol levels significantly on statin treatment. It is important that we see the details of the study results, but this announcement will certainly be welcomed with enthusiasm by the medical and scientific community and is another positive step in the amazing story of PCSK9 inhibition.”
Detailed results from the FOURIER outcomes trial will be presented at the American College of Cardiology (ACC) 66th Annual Scientific Session Late-Breaking Clinical Trials session in Washington, DC on 17 March.
For details on this trial and all aspects of PCSK9 development see the PCSK9 Forum website at www.pcsk9forum.org/