An open-label extension of GLAGOV shows the monoclonal antibody plus statin therapy is not associated with any new safety concerns.
Stephen J. Nicholls, MBBS, PhD
Long-term add-on evolocumab (Repatha) for patients with coronary angiography with coronary artery disease (CAD) and hypercholesterolemia showed sustained reduction of LDL cholesterol (LDL-C) over 2 years of care, according to new findings.
In data originally planned for presentation at the ACC.20 Together with Word Congress of Cardiology (ACC/WCC) Scientific Sessions, a team of Amgen-sponsored investigators found continued, safe, and tolerable benefits of evolocumab plus statin therapy in patients assessed in the GLAGOV study open-label extension.
The GLAGOV randomized clinical trial results, originally published in 2016 by Stephen J. Nicholls, MBBS, PhD, and colleagues, showed patients with angiographic CAD treated with statins plus evolocumab benefitted significantly in decreased percent atheroma volume (PAV) versus placebo over 76 weeks.
Nicholls, of Monash University, and colleagues conducted the open-label extension to characterize longer-term safety and lipid effects associated with the monoclonal antibody plus statins in a cohort of GLAGOV patients who demonstrated reduced LDL-C and coronary atherosclerosis in the original trial.
Patients who completed the 76 weeks of treatment with subcutaneous 420 mg monthly evolocumab or placebo plus optimal statin therapy were eligible for the extension—during which all patients received evolocumab plus standard-of-care.
Nicholls and colleagues assessed for a primary endpoint of incidence of treatment-emergent adverse events (TEAEs) during the open-label extension, as well as LDL-C reduction from the parent study baseline and adjusted clinical events.
The extension included 770 patients receiving at least 1 dose of evolocumab (59.5±8.8 years old; 26% female). Median duration of evolocumab exposure during the extension was 23.7 months, with 92% being exposed for ≥18 months; one-quarter (24%) were exposed for ≥24 months.
More than two-thirds (68.3%) of patients reported a TEAE. Adverse events with a grade of ≥3 were prevalent in 26.8% of patients; serious TEAEs were reported in 19.9% of patients. Just 1.8% of patients discontinued therapy in the extension due to TEAEs.
Adjudicated cardiovascular events occurred in 5.2% of all patients, and investigators reported no new safety findings during the extension.
LDL-C percent change from the original GLAGOV study baseline (92.2±27.3 mg/dL) ranged from 47.9% to 58.5%, and was observed to be sustained in patients who continued evolocumab plus statins from the original trial.
Overall, the study showed a continued and substantial reduction in LDL-C among patients who continued evolocumab as an add-on for angiographic CAD into two-plus years—without any new or emergent issues.
“Long-term treatment with evolocumab added to statins in patients presenting for coronary angiography with CAD and hypercholesterolemia was well-tolerated and safe,” Nicholls and colleagues concluded.
The study, “Effect of Longer-Term Administration of Evolocumab in Patients with Angiographic Coronary Artery Disease: Results of the GLAGOV Open Labelled Extension Study,” was published online in JACC.