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

IF 3.4 2区医学 Q2 PERIPHERAL VASCULAR DISEASE

Journal of atherosclerosis and thrombosis Pub Date : 2026-07-01 Epub Date: 2026-04-15 DOI:10.5551/jat.66069

Kazuma Oyama, Masayuki Yoshida, Arihiro Kiyosue, Nobuhiro Osada, Feng Sheng, Naozumi Harada, Kazumasa Miyawaki, Junichiro Shimauchi, Yang Fu, Shizuya Yamashita

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Abstract

Aims: Lowering low-density lipoprotein cholesterol (LDL-C) is essential for reducing the risk of atherosclerotic cardiovascular disease (ASCVD). This study assessed the clinical efficacy of evolocumab, a human monoclonal antibody targeting PCSK9, in Japanese patients using data from the PROFICIO program.

Methods: Data were pooled from Japanese participants enrolled in five clinical trials: YUKAWA-1, YUKAWA-2, OSLER-1, OSLER-2, and FOURIER. The primary endpoint was percent change in LDL-C from baseline to Week 12. Secondary endpoints included changes in other lipid parameters, achievement of LDL-C targets, incidence of major adverse cardiovascular events (MACE), and subgroup analyses.

Results: A total of 1,040 patients with high cardiovascular risk or established ASCVD were included. At Week 12, the mean percent reduction in LDL-C was 75.7% with evolocumab compared with 1.3% with placebo (least-square mean treatment difference: ‑75.0%; 95% confidence interval [CI]: -76.7 to -73.4; p＜0.001), which was consistent across subgroups. Other lipid parameters showed directionally consistent percent changes, with variable magnitudes across markers. Overall, 92.9% of patients treated with evolocumab achieved an LDL-C ＜55 mg/dL at Week 12 compared with 0.8% of patients in the placebo group. In FOURIER, over a median follow-up of 2.1 years, incidence of MACE was lower with evolocumab than placebo (5.9% vs. 12.4%; hazard ratio: 0.47; 95% CI: 0.24-0.92). Treatment effects on MACE were consistent in both primary and secondary prevention groups (pooled odds ratio: 0.42; 95% CI: 0.23-0.79).

Conclusion: Evolocumab significantly and consistently lowered LDL-C and reduced the risk of MACE in Japanese patients.

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Evolocumab在日本熟练患者中的临床疗效：1040例患者的汇总分析

目的：降低低密度脂蛋白胆固醇（LDL-C）对于降低动脉粥样硬化性心血管疾病（ASCVD）的风险至关重要。本研究使用来自美国熟练项目的数据，评估了evolocumab（一种靶向PCSK9的人单克隆抗体）在日本患者中的临床疗效。方法：数据来自5项临床试验的日本参与者：YUKAWA-1、YUKAWA-2、OSLER-1、OSLER-2和FOURIER。主要终点是LDL-C从基线到第12周的百分比变化。次要终点包括其他脂质参数的变化、LDL-C目标的实现、主要不良心血管事件（MACE）的发生率和亚组分析。结果：共纳入1040例心血管高危或ASCVD患者。在第12周，evolocumab组LDL-C的平均降低率为75.7%，而安慰剂组为1.3%（最小二乘平均治疗差：- 75.0%；95%可信区间[CI]: -76.7至-73.4;p<0.001），这在亚组中是一致的。其他脂质参数显示出方向一致的百分比变化，不同标记物的幅度不同。总体而言，92.9%接受evolocumab治疗的患者在第12周达到LDL-C <55 mg/dL，而安慰剂组为0.8%。在FOURIER中，中位随访期为2.1年，evolocumab的MACE发生率低于安慰剂（5.9% vs 12.4%；风险比：0.47;95% CI: 0.24-0.92）。一级和二级预防组对MACE的治疗效果一致（合并优势比：0.42;95% CI: 0.23-0.79）。结论：Evolocumab显著且持续地降低了日本患者的LDL-C并降低了MACE的风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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