Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease

Area of Science:

• Cardiovascular Medicine
• Pharmacology
• Clinical Trials

Background:

• The FOURIER trial showed evolocumab reduced LDL-C and cardiovascular events.
• Long-term data on evolocumab's safety and efficacy were limited.

Purpose of the Study:

• To evaluate the long-term safety and efficacy of evolocumab in patients with atherosclerotic cardiovascular disease.
• To assess cardiovascular outcomes and adverse events over an extended period.

Main Methods:

• Patients from the FOURIER trial were enrolled in open-label extension studies (FOURIER-OLE).
• Data were pooled from US and European extension studies, with primary analyses focusing on adverse event incidence.
• Lipid values and major adverse cardiovascular events were prospectively collected over a median of 5.0 years of follow-up.

Main Results:

• Evolocumab treatment led to a median LDL-C of 30 mg/dL, with 63.2% achieving LDL-C <40 mg/dL.
• Long-term adverse event rates (serious AEs, muscle events, new diabetes, stroke, neurocognitive events) did not exceed placebo and showed no increase over time.
• Patients on evolocumab had a 15% lower risk of major adverse cardiovascular events and a 23% lower risk of cardiovascular death compared to placebo.

Conclusions:

• Long-term LDL-C lowering with evolocumab is safe and well-tolerated for over 8 years.
• Evolocumab demonstrated sustained cardiovascular risk reduction compared to delayed treatment initiation.
• The study supports the long-term benefit of evolocumab in high-risk cardiovascular patients.