Effects of Fenofibric Acid on Carotid Intima-Media Thickness in Patients With Mixed Dyslipidemia on Atorvastatin Therapy Randomized, Placebo-Controlled Study ( FIRST)
Effects of Fenofibric Acid on Carotid Intima-Media Thickness in Patients With Mixed Dyslipidemia on Atorvastatin Therapy Randomized, Placebo-Controlled Study ( FIRST)
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DOI：
10.1161/atvbaha.113.302926
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发表时间：
2014-06-01
影响因子：
8.7
通讯作者：
Stolzenbach, James C.
中科院分区：
文献类型：
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作者：
Davidson, Michael H.;Rosenson, Robert S.;Stolzenbach, James C.
目的评估非诺贝特胆碱（ABT-335）对有残留风险的IIb型血脂异常患者颈动脉内膜-中膜厚度（cIMT）的影响。此外，阿托伐他汀治疗（FIRST）试验评估了非诺贝特酸（FA）治疗阿托伐他汀混合血脂异常患者颈动脉内膜-中膜厚度（cIMT）的影响。方法和结果：这项多中心、双盲、安慰剂对照研究是在混合性血脂异常（空腹甘油三酯150 mg/dL；高密度脂蛋白胆固醇45[男性]或55 mg/dL[女性]；低密度脂蛋白胆固醇100 mg/dL一次，平均105 mg/dL）和冠心病史或同等风险的患者中进行的。背景服用阿托伐他汀的患者（如果需要，继续服用起始剂量或滴定至40mg）被随机分配到135mg FA或安慰剂组。主要终点是通过超声测量的平均后壁cIMT从基线到第104周的变化率。在接受阿托伐他汀背景治疗的低密度脂蛋白胆固醇控制患者中，FA +阿托伐他汀后壁cIMT变化率与阿托伐他汀单药治疗（0.000 mm/y； P=0.22）相似（-0.006 mm/y）。FA +阿托伐他汀更受青睐(P0.795 mm，甘油三酯170 - 235 mg/dL，他汀类药物在入组时使用。不良事件与两种药物已知的安全性一致；然而，与阿托伐他汀单药治疗相比，FA +阿托伐他汀与肾脏相关不良事件的发生率更高（6.5% vs 0.9%）。结论与阿托伐他汀单药治疗相比，FA +阿托伐他汀不能进一步降低混合性血脂异常高危患者的cIMT进展。
Objective To assess whether adding a fibrate to statin therapy reduces residual cardiovascular risk associated with elevated triglycerides and low high-density lipoprotein cholesterol, The Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects with Type IIb Dyslipidemia with Residual Risk in Addition to Atorvastatin Therapy (FIRST) trial evaluated the effects of fenofibric acid (FA) treatment on cIMT in patients with mixed dyslipidemia on atorvastatin.Approach and Results This multicenter, double-blind, placebo-controlled study was performed in patients with mixed dyslipidemia (fasting triglycerides, 150 mg/dL; high-density lipoprotein cholesterol, 45 [men] or 55 mg/dL [women]; low-density lipoprotein cholesterol, 100 mg/dL once and averaging 105 mg/dL) and a history of coronary heart disease or risk equivalent. Patients on background atorvastatin (continued on starting dose or titrated to 40 mg, if needed) were randomized to FA 135 mg or placebo. The primary end point was rate of change from baseline through week 104 of the mean posterior-wall cIMT, measured by ultrasound. In patients with controlled low-density lipoprotein cholesterol while on atorvastatin background therapy, rate of change in posterior-wall cIMT was similar with FA plus atorvastatin (-0.006 mm/y) versus atorvastatin monotherapy (0.000 mm/y; P=0.22). FA plus atorvastatin was favored (P0.795 mm, triglycerides 170 to 235 mg/dL, and statin use at entry. Adverse events were consistent with the known safety profiles of both drugs; however, FA plus atorvastatin was associated with a greater incidence of renal-related adverse events compared with atorvastatin monotherapy (6.5% versus 0.9%).Conclusions Compared with atorvastatin monotherapy, FA plus atorvastatin did not further decrease cIMT progression in high-risk patients with mixed dyslipidemia.