Physicians' Academy for Cardiovascular Education

Early and long-term PCSK9i use associated with continued CV benefit

News - Aug. 30, 2022

Long-term evolocumab in patients with established atherosclerotic cardiovascular disease: primary results of the FOURIER-OLE (open-label extension) studies

Presented at the ESC congress 2022 by: Michelle O’Donoghue, MD- Boston, MA, USA

Introduction and methods

In the FOURIER trial, the PCSK9i evolocumab reduced LDL-c levels and the incidence of CV events compared with placebo but not CV death in ASCVD patients with LDL-c ≥70 mg/dL on optimized statin treatment. Over the median follow-up time of 2.2 years, the drug was safe and well-tolerated. At select sites in Europe and the US, an open-label extension (OLE) study was subsequently conducted in 6634 patients who completed the parent FOURIER trial.

All FOURIER-OLE patients self-injected open-label evolocumab (also the patients who were originally allocated to placebo in the parent study), with the choice of 140 mg biweekly or 420 mg monthly (same as in parent study). Median follow-up duration of the FOURIER-OLE study was 5.0 years (maximum exposure to evolocumab in FOURIER plus FOURIER-OLE: 8.4 years).

The primary endpoint was the composite outcome of CV death, MI, stroke, unstable angina, or coronary vascularization. The key secondary endpoint was the composite outcome of CV death, MI, or stroke.

Main results


Long-term use of evolocumab (median follow-up duration >7 years) led to durable LDL-c reduction and was both safe and well-tolerated. Early initiation of this treatment was associated with continued accumulation of CV benefit, including CV death, over the next several years. According to Dr. O’Donoghue, “these findings argue for early initiation of a marked and sustained LDL-c reduction to maximize clinical benefit.”

-Our reporting is based on the information provided at the ESC Congress-

The results of this study were simultaneously published in Circulation. Watch a video about the FOURIER-OLE study

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