Residual Risk Reduction Initiative (R3i) Foundation, Picassoplatz 8, Basel, 4010, Switzerland.
Rinku General Medical Center, Izumisano, Osaka, Japan.
Cardiovasc Diabetol. 2024 Jul 29;23(1):279. doi: 10.1186/s12933-024-02305-z.
The neutral result of the PROMINENT trial has led to questions about the future for pemafibrate. This commentary discusses possible reasons for the lack of benefit observed in the trial. There were, however, indicators suggesting therapeutic potential in microvascular ischaemic complications associated with peripheral artery disease, with subsequent analysis showing reduction in the incidence of lower extremity ischaemic ulceration or gangrene. Reassurance about the safety of pemafibrate, together with emerging data from PROMINENT and experimental studies, also suggest benefit with pemafibrate in non-alcoholic fatty liver disease (alternatively referred to as metabolic dysfunction-associated steatotic liver disease) and microangiopathy associated with diabetes, which merit further study.
PROMINENT 试验的中性结果引发了人们对 pemafibrate 未来的质疑。本文讨论了试验中观察到缺乏益处的可能原因。然而,有迹象表明其在外周动脉疾病相关的微血管缺血性并发症方面具有治疗潜力,随后的分析显示下肢缺血性溃疡或坏疽的发生率降低。pemafibrate 的安全性得到保证,加上来自 PROMINENT 试验和实验研究的新数据,也提示其在非酒精性脂肪性肝病(另称为代谢功能障碍相关脂肪性肝病)和糖尿病相关微血管病变方面可能有益,值得进一步研究。