Real-World Safety and Effectiveness of Evolocumab in Korean Patients with Atherosclerotic Cardiovascular Disease or Familial Hypercholesterolemia: A Post-Marketing Surveillance Study.

ABSTRACT:

Introduction

The efficacy and safety of evolocumab have been established in clinical trials. This post-marketing surveillance (PMS) study investigated the real-world safety and effectiveness of evolocumab in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) in Korea.

Methods

Patients who received evolocumab for approved indications in Korea between April 2017 and April 2023 across 43 centers were enrolled in this prospective PMS study. Safety (adverse events [AEs] and serious adverse events [SAEs]) and effectiveness (low-density lipoprotein cholesterol [LDL-C] lowering) were assessed up to 52 weeks. AEs and SAEs were categorized by LDL-C levels at 12 weeks: < 20, 20-40, and ≥ 40 mg/dL.

Results

Overall, 539 patients (mea

SUBMITTER: Moon D 

PROVIDER: S-EPMC12680816 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature