Vergès Bruno
Service Endocrinologie, Diabétologie et Maladies Métaboliques, Centre Hospitalier Universitaire de Dijon, Dijon, France.
Curr Opin Lipidol. 2006 Dec;17(6):653-8. doi: 10.1097/01.mol.0000252612.21602.e3.
The aim of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was to provide valuable information on the ability of fibrates to reduce cardiovascular risk in type 2 diabetes. The purpose of this review is to analyse results from FIELD and to see whether they may lead to modify the recommendations for treatment of diabetic dyslipidemia.
In FIELD, fenofibrate therapy was associated with a nonsignificant 11% reduction in the primary endpoint (coronary heart disease death, nonfatal myocardial infarction), corresponding to a significant 24% reduction in nonfatal myocardial infarction (P = 0.010) and a nonsignificant 19% increase in CHD mortality. Fenofibrate reduced CHD events only in patients in primary prevention, but not in secondary prevention. Fenofibrate treatment was associated with less albuminuria progression and less retinopathy needing laser treatment.
FIELD's results are somewhat disappointing. The relatively low cardiovascular risk population from FIELD and the 'pollution' by statin therapy may not totally explain the weak results of fenofibrate in the reduction in CHD events. The significant increase in plasma homocysteine observed with fenofibrate could partly explain not only the higher number of venous thrombotic events, but also the poor effect of fenofibrate in reducing clinical outcomes, more particularly in patients with previous cardiovascular disease.
非诺贝特干预与糖尿病事件降低(FIELD)研究的目的是提供有关贝特类药物降低2型糖尿病患者心血管风险能力的有价值信息。本综述的目的是分析FIELD研究的结果,看看它们是否可能导致修改糖尿病血脂异常的治疗建议。
在FIELD研究中,非诺贝特治疗与主要终点(冠心病死亡、非致命性心肌梗死)降低11%无显著关联,其中非致命性心肌梗死显著降低24%(P = 0.010),冠心病死亡率无显著升高19%。非诺贝特仅在一级预防患者中降低冠心病事件,而在二级预防中无效。非诺贝特治疗与较少的蛋白尿进展和较少需要激光治疗的视网膜病变相关。
FIELD研究的结果有些令人失望。FIELD研究中相对较低心血管风险的人群以及他汀类药物治疗的“干扰”可能无法完全解释非诺贝特在降低冠心病事件方面效果不佳的原因。非诺贝特治疗后观察到的血浆同型半胱氨酸显著升高不仅可以部分解释静脉血栓形成事件数量增加,还可以解释非诺贝特在降低临床结局方面效果不佳尤其是在既往有心血管疾病的患者中。