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[FIELD,非诺贝特用于2型糖尿病心血管预防的随机临床试验]

[Field, a randomized clinical trial of cardiovascular prevention with fenofibrate in type 2 diabetes].

作者信息

Radermecker R P, Scheen A J

机构信息

Département de Médecine, CHU Sart Tilman, 4000 Liège.

出版信息

Rev Med Liege. 2005 Dec;60(12):957-61.

Abstract

FIELD ("Fenofibrate Intervention and Events Lowering in Diabetes") study compared the incidence of coronary and cardiovascular events in 4895 patients with type 2 diabetes treated with fenofibrate (micronized fomulation, 200 mg/day) and in 4900 patients treated with placebo. After a mean 5-year follow-up, the fenofibrate group did not have less coronary events (primary endpoint), neither present a significant reduction in cardiovascular or total mortality as compared to the placebo group. However, it had significantly less non-fatal myocardial infarctions and cardiovascular events in general as well as less coronary and total revascularization procedures (secondary endpoints). The higher rate of starting statin therapy in patients allocated placebo might have masked a larger treatment benefit of fenofibrate on macrovascular complications. The tolerance of fenofibrate was good, even in combination with statins. More surprisingly, fenofibrate exerted a favourable effect on microangiopathy complications, with less albuminuria progression and less retinopathy needing laser treatment (tertiary endpoints).

摘要

FIELD(非诺贝特干预与糖尿病事件降低)研究比较了4895例接受非诺贝特(微粒化制剂,200毫克/天)治疗的2型糖尿病患者与4900例接受安慰剂治疗的患者发生冠状动脉和心血管事件的发生率。经过平均5年的随访,非诺贝特组的冠状动脉事件(主要终点)并不少于安慰剂组,与安慰剂组相比,心血管或总死亡率也没有显著降低。然而,总体而言,该组非致命性心肌梗死和心血管事件明显较少,冠状动脉和总血管重建手术(次要终点)也较少。分配到安慰剂组的患者开始他汀类药物治疗的比例较高,这可能掩盖了非诺贝特对大血管并发症更大的治疗益处。非诺贝特的耐受性良好,即使与他汀类药物联合使用也是如此。更令人惊讶的是,非诺贝特对微血管病变并发症产生了有利影响,蛋白尿进展较少,需要激光治疗的视网膜病变也较少(三级终点)。

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