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研究概要FIELD研究共纳入9,795名2型糖尿病患者,随机分入安慰剂组和非诺贝特200mg/d组,平均随访5年。根据估算肾小球滤过率(eGFR,单位mL/min/1.73m2)水平,将患者分为>90、60～89和30～59三组。主要终点是总的心血管事件,包括心血管死亡、心梗、中风、冠状动脉/颈动脉血运重建。与安慰剂组相比,非诺贝特可使总的心血管事件降低11%。与eGFR>90患者相比,eGFR30～59患者心血管疾病发生风险显著降低,但是,组间比较没有统计学意义。与其他两组相比,eGFR30～59患者终末期肾病发病率最高。但是,与安慰剂组相比,非诺贝特组终末期肾病发病率没有增加,无论是整体还是任意一组。非诺贝特导致血浆肌酐水平增加的程度并不能预测终末期肾病的发生。与安慰剂组相比,非诺贝特组患者的不良事件发生率并不高,包括eGFR30～59的患者。
Study Summary The FIELD study enrolled 9,795 patients with type 2 diabetes who were randomized to placebo and fenofibrate 200 mg daily for a mean follow-up of 5 years. Patients were divided into three groups> 90, 60-89 and 30-59 according to the estimated glomerular filtration rate (eGFR, unit mL / min / 1.73m2) level. The primary endpoint was total cardiovascular events, including cardiovascular death, MI, stroke, and coronary / carotid revascularization. Fenofibrate reduced overall cardiovascular events by 11% compared with placebo. Compared with eGFR> 90 patients, patients with eGFR30 ~ 59 significantly reduced the risk of cardiovascular disease, but the comparison between the two groups was not statistically significant. Compared with the other two groups, eGFR30 ~ 59 patients had the highest incidence of end-stage renal disease. However, the incidence of end-stage renal disease did not increase in the fenofibrate group compared with placebo, either overall or in any of the groups. The extent to which fenofibrate causes an increase in plasma creatinine does not predict the occurrence of end-stage renal disease. The incidence of adverse events was not high in the fenofibrate group compared with placebo, including patients with eGFR30-59.