在阿托伐他汀治疗的混合性血脂异常患者中，非诺贝特酸对颈动脉内膜中层厚度的影响：随机、安慰剂对照研究（FIRST）。
Effects of fenofibric acid on carotid intima-media thickness in patients with mixed dyslipidemia on atorvastatin therapy: randomized, placebo-controlled study (FIRST).
机构信息
From the Department of Medicine, University of Chicago, IL (M.H.D.); Icahn School of Medicine at Mount Sinai, New York, NY (R.S.R.); Biofortis Clinical Research, Addison, IL (K.C.M.); Cardiology, University of Adelaide, Adelaide, Australia (S.J.N.); Consultant Cardiologist, Royal Adelaide Hospital, Adelaide, Australia (S.J.N.); Section of Cardiology, Section of Atherosclerosis and Vascular Medicine, and Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, TX (C.M.B.); the Maria and Alando J. Ballantyne, MD, Atherosclerosis Laboratory, and Lipid Metabolism and Atherosclerosis Clinic, The Methodist Hospital, Houston, TX (C.M.B.); Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Illinois at Chicago (T.M.); and Global Pharmaceutical Research and Development (D.M.C., L.A.W., M.T.K., H.S.C., J.C.S), and Data and Statistical Sciences (A.L.), AbbVie Inc, North Chicago, IL.
出版信息
Arterioscler Thromb Vasc Biol. 2014 Jun;34(6):1298-306. doi: 10.1161/ATVBAHA.113.302926. Epub 2014 Apr 17.
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 (P<0.05) in 5 of 24 prespecified subgroups: age ≥60 years, history of coronary artery disease, cIMT >0.795 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.
目的
评估在他汀类药物治疗的基础上加用贝特类药物是否能降低与甘油三酯升高和高密度脂蛋白胆固醇降低相关的残余心血管风险。ABT-335（即考来烯胺芬氟拉明酸）在他汀类药物治疗后仍存在残余风险的 2 型 b 型血脂异常患者中对颈动脉内膜中层厚度（cIMT）的影响（FIRST）试验评估了贝特酸类药物（FA）治疗对阿托伐他汀治疗混合性血脂异常患者 cIMT 的影响。
方法和结果
本项多中心、双盲、安慰剂对照研究在患有混合性血脂异常（空腹甘油三酯≥150mg/dL；高密度脂蛋白胆固醇≤45[男性]或 55mg/dL[女性]；低密度脂蛋白胆固醇≤100mg/dL，且单次测量值≤105mg/dL，平均测量值≤105mg/dL）和冠心病或等同风险史的患者中进行。接受背景阿托伐他汀治疗的患者（继续服用起始剂量或滴定至 40mg，如果需要）被随机分为 FA 135mg 或安慰剂组。主要终点是通过超声测量的基线至 104 周时后侧壁 cIMT 的平均变化率。在接受阿托伐他汀背景治疗的患者中，低密度脂蛋白胆固醇得到控制的情况下，后侧壁 cIMT 的变化率在 FA 联合阿托伐他汀组（-0.006mm/y）与阿托伐他汀单药治疗组（0.000mm/y；P=0.22）相似。在 24 个预先指定的亚组中的 5 个亚组中，FA 联合阿托伐他汀具有优势（P<0.05）：年龄≥60 岁、有冠心病史、cIMT>0.795mm、甘油三酯 170-235mg/dL 和他汀类药物起始治疗时的使用。不良事件与两种药物的已知安全性特征一致；然而，FA 联合阿托伐他汀与阿托伐他汀单药治疗相比，更易发生与肾脏相关的不良事件（6.5%比 0.9%）。
结论
与阿托伐他汀单药治疗相比，在高风险混合性血脂异常患者中，FA 联合阿托伐他汀并未进一步降低 cIMT 进展。
Zotero 插件