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Clinical Efficacy with Evolocumab among Japanese Patients in PROFICIO: A Pooled Analysis of 1,040 Patients

Kazuma Oyama1, Masayuki Yoshida2, Arihiro Kiyosue3

  • 1Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine.

Journal of Atherosclerosis and Thrombosis
|April 16, 2026
PubMed

Insights

Evolocumab significantly reduced low-density lipoprotein cholesterol (LDL-C) and major adverse cardiovascular events (MACE) in Japanese patients. This PCSK9 inhibitor demonstrated high efficacy and safety in high-risk individuals.

Area of Science:

  • Cardiology
  • Pharmacology
  • Biochemistry

Background:

  • Lowering low-density lipoprotein cholesterol (LDL-C) is crucial for preventing atherosclerotic cardiovascular disease (ASCVD).
  • PCSK9 inhibitors, like evolocumab, offer a novel therapeutic approach to manage hypercholesterolemia.
  • Japanese patients represent a distinct population with specific cardiovascular risk profiles.

Purpose of the Study:

  • To evaluate the clinical efficacy and safety of evolocumab in Japanese patients with high cardiovascular risk or established ASCVD.
  • To assess the impact of evolocumab on LDL-C levels and achievement of lipid targets.
  • To determine the effect of evolocumab on the incidence of major adverse cardiovascular events (MACE).

Main Methods:

  • Pooled data from five clinical trials (YUKAWA-1, YUKAWA-2, OSLER-1, OSLER-2, FOURIER) involving Japanese participants.
  • Primary endpoint: percent change in LDL-C from baseline to Week 12.
  • Secondary endpoints: changes in other lipids, LDL-C target attainment, MACE incidence, and subgroup analyses.

Main Results:

  • Evolocumab achieved a mean 75.7% LDL-C reduction at Week 12 versus 1.3% for placebo (p＜0.001).
  • 92.9% of evolocumab-treated patients reached LDL-C <55 mg/dL, compared to 0.8% with placebo.
  • In the FOURIER trial, evolocumab reduced MACE by 53% (hazard ratio: 0.47; 95% CI: 0.24-0.92) over 2.1 years.

Conclusions:

  • Evolocumab demonstrated significant and consistent LDL-C lowering in Japanese patients.
  • The PCSK9 inhibitor effectively reduced MACE in both primary and secondary prevention groups.
  • Evolocumab is a safe and effective treatment option for high-risk Japanese patients requiring intensive lipid-lowering therapy.
Abstract

Keywords:
Atherosclerotic cardiovascular diseaseEvolocumabHypercholesterolemiaLow-density lipoprotein cholesterolPCSK9 inhibitor

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