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[显著试验:贝特类药物的绝唱]

[The PROMINENT trial: swan song of the fibrates].

作者信息

van Sloten Thomas T, Martens Fabrice M A C, Visseren Frank L J

机构信息

UMC Utrecht, afd. Vasculaire Geneeskunde, Utrecht.

Contact: Thomas T. van Sloten (

出版信息

Ned Tijdschr Geneeskd. 2023 Apr 5;167:D7528.

Abstract

Post hoc analyses of previous fibrate trials have suggested that individuals with type 2 diabetes mellitus with high triglyceride levels and low HDL-cholesterol levels benefit from fibrate therapy even when the overall trial results were neutral. However the PROMINENT (Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes) trial seems to close the door for fibrates. The trial found that fibrates do not reduce the risk of cardiovascular disease among individuals with type 2 diabetes and high triglyceride levels and low HDL cholesterol levels, despite triglyceride lowering. The results of PROMINENT suggest that triglyceride lowering without decreases in the plasma concentration of atherogenic lipoproteins are unlikely to decrease the risk of cardiovascular disease. These results also highlight the importance of rigorously confirmation of post hoc findings before implementation in clinical practice.

摘要

既往贝特类药物试验的事后分析表明,患有2型糖尿病、甘油三酯水平高且高密度脂蛋白胆固醇水平低的个体,即便整体试验结果呈中性,仍能从贝特类药物治疗中获益。然而,“显著”(Pemafibrate通过降低糖尿病患者甘油三酯水平以降低心血管结局)试验似乎为贝特类药物关上了大门。该试验发现,尽管贝特类药物能降低甘油三酯水平,但在患有2型糖尿病、甘油三酯水平高且高密度脂蛋白胆固醇水平低的个体中,贝特类药物并不能降低心血管疾病风险。“显著”试验的结果表明,在不降低致动脉粥样硬化脂蛋白血浆浓度的情况下降低甘油三酯水平,不太可能降低心血管疾病风险。这些结果还凸显了在临床实践中实施之前,严格证实事后分析结果的重要性。

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