Watanabe Yasuhiro, Nonaka Shoya, Yamaoka Shuhei, Nakamura Shoko, Horikawa Osamu, Yamaguchi Takashi, Sato Shuji, Todani Shunsuke, Sugizaki Yuta, Ito Takuro, Mikamo Hiroshi, Takahashi Mao, Nagayama Daiji, Shimizu Kazuhiro, Saiki Atsuhito
Center of Diabetes, Endocrine and Metabolism, Toho University Sakura Medical Center, Chiba, Japan.
Division of Cardiology, Department of Internal Medicine, Toho University Sakura Medical Center, Chiba, Japan.
Vasc Health Risk Manag. 2025 Apr 24;21:293-304. doi: 10.2147/VHRM.S506642. eCollection 2025.
Pemafibrate is a novel selective peroxisome proliferator-activated receptor alpha modulator (SPPARMα) that improves lipid profile, but its effects on cardiovascular events remain unproven. This study examined changes in the cardio-ankle vascular index (CAVI), a marker of arterial stiffness, in high-risk patients with type 2 diabetes mellitus (T2DM) or ischemic heart disease (IHD) treated with pemafibrate.
In this single-center, prospective, observational study, 95 patients with T2DM and/or IHD, who had hypertriglyceridemia (≥150 mg/dL) and started pemafibrate (0.2 mg/day) were analyzed. CAVI was measured at baseline and after 24 weeks of treatment as an indicator of arterial stiffness, along with comprehensive assessment of lipid parameters including triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), non-HDL-C, and apolipoproteins.
No significant change in CAVI was observed after 24 weeks of treatment (median [interquartile range (IQR)]; baseline vs 24 weeks: CAVI 9.4 [8.8-10.6] vs 9.6 [8.9-10.8], p=0.715). However, pemafibrate significantly reduced triglycerides (233 mg/dL [171-329] to 143 mg/dL [111-187], p<0.001), apolipoprotein C-II (8.1 mg/dL [6.1-10.2] to 6.3 mg/dL [5.3-8.3], p<0.001), apolipoprotein C-III (15.3 mg/dL [12.2-18.3] to 11.6 mg/dL [9.3-14.2], p<0.001) and liver enzymes; and increased HDL-C (45 mg/dL [39-52] to 50 mg/dL [40-60], p<0.001), LDL-C (92 mg/dL [70-111] to 103 mg/dL [79-128], p<0.001), apolipoprotein A-I and apolipoprotein A-II (both p<0.05). Calculated small dense low-density lipoprotein cholesterol also decreased significantly (40 mg/dL [31-49] to 36 mg/dL [28-45], p=0.002).
While pemafibrate improves lipid profile and liver enzymes, its short-term impact on vascular stiffness, as measured by CAVI, appears limited. Extended follow-up studies are needed to clarify its cardiovascular benefits in high-risk patients.
佩马贝特是一种新型的选择性过氧化物酶体增殖物激活受体α调节剂（SPPARMα），可改善血脂水平，但其对心血管事件的影响尚未得到证实。本研究探讨了佩马贝特治疗的2型糖尿病（T2DM）或缺血性心脏病（IHD）高危患者的心脏-踝血管指数（CAVI）（一种动脉僵硬度标志物）的变化。
在这项单中心、前瞻性观察研究中，分析了95例患有T2DM和/或IHD、伴有高甘油三酯血症（≥150mg/dL）且开始服用佩马贝特（0.2mg/天）的患者。在基线和治疗24周后测量CAVI作为动脉僵硬度指标，同时对包括甘油三酯、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）、非HDL-C和载脂蛋白在内的血脂参数进行综合评估。
治疗24周后未观察到CAVI有显著变化（中位数[四分位间距（IQR）]；基线与24周：CAVI 9.4[8.8 - 10.6]对9.6[8.9 - 10.8]，p = 0.715）。然而，佩马贝特显著降低了甘油三酯（从233mg/dL[171 - 329]降至143mg/dL[111 - 187]，p < 0.001）、载脂蛋白C-II（从8.1mg/dL[6.1 - 10.2]降至6.3mg/dL[5.3 - 8.3]，p < 0.001）、载脂蛋白C-III（从15.3mg/dL[12.2 - 18.3]降至11.6mg/dL[9.3 - 14.2]，p < 0.001）和肝酶；并升高了HDL-C（从45mg/dL[39 - 5
