Department of Cardiology, Iwate Prefectural Central Hospital, 1-4-1 Ueda, Morioka, 020-0066, Japan.
Heart Vessels. 2024 Jun;39(6):486-495. doi: 10.1007/s00380-024-02363-z. Epub 2024 Feb 23.
This study examined the effects of pemafibrate, a selective peroxisome proliferator-activated receptor α agonist, on the serum biochemical parameters of male patients with coronary artery disease and metabolic syndrome (MetS). This was a post hoc analysis of a randomized, crossover study that treated hypertriglyceridemia with pemafibrate or bezafibrate for 24 weeks, followed by a crossover of another 24 weeks. Of the 60 patients enrolled in the study, 55 were male. Forty-one of 55 male patients were found to have MetS. In this sub-analysis, male patients with MetS (MetS group, n = 41) and those without MetS (non-MetS group, n = 14) were compared. The primary endpoint was a change in fasting serum triglyceride (TG) levels during pemafibrate therapy, and the secondary endpoints were changes in insulin resistance-related markers and liver function parameters. Serum TG levels significantly decreased (MetS group, from 266.6 to 148.0 mg/dL, p < 0.001; non-MetS group, from 203.9 to 97.6 mg/dL, p < 0.001); however, a percent change (%Change) was not significantly different between the groups (- 44.1% vs. - 51.6%, p = 0.084). Serum insulin levels and homeostasis model assessment of insulin resistance significantly decreased in the MetS group but not in the non-MetS group. %Change in liver enzyme levels was markedly decreased in the MetS group compared with that in the non-MetS group (alanine aminotransferase, - 25.1% vs. - 11.3%, p = 0.027; gamma-glutamyl transferase, - 45.8% vs. - 36.2%, p = 0.020). In conclusion, pemafibrate can effectively decrease TG levels in patients with MetS, and it may be a more efficient drug for improving insulin resistance and liver function in such patients.
这项研究旨在探讨选择性过氧化物酶体增殖物激活受体 α 激动剂 pemafibrate 对伴有代谢综合征(MetS)的男性冠心病患者血清生化参数的影响。这是一项针对接受 pemafibrate 或 bezafibrate 治疗 24 周后转为另一项治疗 24 周的随机交叉研究的事后分析。在这项研究中,共有 60 名患者入组,其中 55 名为男性。55 名男性中有 41 名患有 MetS。在这项亚分析中,将患有 MetS 的男性患者(MetS 组,n=41)和不患有 MetS 的男性患者(非 MetS 组,n=14)进行了比较。主要终点是 pemafibrate 治疗期间空腹血清甘油三酯(TG)水平的变化,次要终点是胰岛素抵抗相关标志物和肝功能参数的变化。血清 TG 水平显著降低(MetS 组,从 266.6 降至 148.0mg/dL,p<0.001;非 MetS 组,从 203.9 降至 97.6mg/dL,p<0.001);然而,两组间的百分比变化(%Change)无显著差异(-44.1%与-51.6%,p=0.084)。MetS 组的血清胰岛素水平和胰岛素抵抗评估的稳态模型显著降低,但非 MetS 组无此变化。MetS 组的肝酶水平的%Change 明显低于非 MetS 组(丙氨酸氨基转移酶,-25.1%与-11.3%,p=0.027;γ-谷氨酰转移酶,-45.8%与-36.2%,p=0.020)。总之,pemafibrate 可有效降低伴有 MetS 的患者的 TG 水平,且对于改善此类患者的胰岛素抵抗和肝功能,pemafibrate 可能是一种更有效的药物。