Evolocumab Modifies IVUS-Detected Coronary Atherosclerosis: Topline Results From GLAGOV

The addition of the PCSK9 inhibitor evolocumab (Repatha) to maximally tolerated statin therapy in patients with evidence of coronary artery disease significantly modifies atheroma volume as assessed by IVUS, according to topline results announced today.

Although the findings are not fully known—companies have a financial obligation to release topline results that might materially affect shareholders—Amgen, the maker of evolocumab, said the GLAGOV (Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound) trial met its primary and secondary endpoints.

The study, led by Steven Nissen, MD (Cleveland Clinic, OH), and Stephen Nicholls, MBBS (University of Adelaide, Australia), includes 968 patients undergoing cardiac catheterization for coronary artery disease optimized on background statin therapy. The primary endpoint of the trial is the change in percent atheroma volume (PAV) from baseline to week 78 for evolocumab compared with placebo. Secondary endpoints include PAV regression, change in total atheroma volume (TAV), and TAV regression.

Full results of GLAGOV are slated for presentation Tuesday, November 15, 2016, at the American Heart Association Scientific Sessions in New Orleans, LA.

Evolocumab and alirocumab (Praluent, Sanofi/Regeneron) were approved in 2015, both on the strength of their ability to lower LDL cholesterol levels. Eagerly anticipated are the results of the large outcomes studies, however, to determine if the drugs do more than improve cholesterol levels. Physicians are awaiting the results of FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a 27,500-patient cardiovascular outcomes trial testing the ability of evolocumab to reduce the risk of cardiovascular death, MI, hospitalization for unstable angina, stroke, or coronary revascularization.

The results of FOURIER are expected in the first quarter of 2017, likely in advance of findings from the 18,000-patient ODYSSEY-Outcomes study testing alirocumab.

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