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Introduction <p>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.</p> Methods <p>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&#xa0;weeks. AEs and SAEs were categorized by LDL-C levels at 12&#xa0;weeks: &lt; 20, 20–40, and ≥ 40&#xa0;mg/dL.</p> Results <p>Overall, 539 patients (mean age 58.8 ± 11.1&#xa0;years, 78.7%/21.3% male/female) were included in the safety analysis set, while 361 patients assessed for LDL-C at least once during follow-up were included in the effectiveness analysis set. The majority of patients had ASCVD (myocardial infarction [55.1%], angina [33.5%], cerebral infarction [13.2%], peripheral artery disease [4.5%]). AEs were reported by 23.9% of patients, with SAEs occurring in 7.1%. When stratified by LDL-C levels, there was no difference in the frequencies of AEs and SAEs. Among all adverse drug reactions (ADRs; 2.4%), the most common were myalgia (0.9%) and headache (0.4%), with no reports of hemorrhagic stroke or nasopharyngitis. Evolocumab significantly reduced LDL-C levels from a baseline median of 100.2&#xa0;mg/dL by 70.6% at week 12 and 69.0% at 52&#xa0;weeks, achieving a target LDL-C goal (&lt; 55&#xa0;mg/dL and &gt; 50% reduction) in 68.1% and 69.2% of patients, respectively.</p> Conclusions <p>Evolocumab effectively lowered LDL-C levels and had a favorable safety profile in Korean patients with ASCVD or FH. The incidence of AEs was lower than in clinical trials, and no ADRs were observed among the SAEs. These results support the use of evolocumab as a viable therapeutic option.</p>

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

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  • 发表日期：

    2025年10月8日

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  • Donggyu Moon,
  • Seung-Ho Hur,
  • Sang-Rok Lee,
  • Myung Ho Jeong,
  • Kyung Hoon Cho,
  • Osung Kwon,
  • JinSeon Jeong,
  • Ki Dong Yoo

摘要

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 (mean age 58.8 ± 11.1 years, 78.7%/21.3% male/female) were included in the safety analysis set, while 361 patients assessed for LDL-C at least once during follow-up were included in the effectiveness analysis set. The majority of patients had ASCVD (myocardial infarction [55.1%], angina [33.5%], cerebral infarction [13.2%], peripheral artery disease [4.5%]). AEs were reported by 23.9% of patients, with SAEs occurring in 7.1%. When stratified by LDL-C levels, there was no difference in the frequencies of AEs and SAEs. Among all adverse drug reactions (ADRs; 2.4%), the most common were myalgia (0.9%) and headache (0.4%), with no reports of hemorrhagic stroke or nasopharyngitis. Evolocumab significantly reduced LDL-C levels from a baseline median of 100.2 mg/dL by 70.6% at week 12 and 69.0% at 52 weeks, achieving a target LDL-C goal (< 55 mg/dL and > 50% reduction) in 68.1% and 69.2% of patients, respectively.

Conclusions

Evolocumab effectively lowered LDL-C levels and had a favorable safety profile in Korean patients with ASCVD or FH. The incidence of AEs was lower than in clinical trials, and no ADRs were observed among the SAEs. These results support the use of evolocumab as a viable therapeutic option.