Bays Harold, McElhattan Jennifer, Bryzinski Brian S
Louisville Metabolic and Atherosclerosis Research Center Inc. (L-MARC), 3288 Illinois Avenue, Louisville, KY 40213, USA.
Diab Vasc Dis Res. 2007 Sep;4(3):181-93. doi: 10.3132/dvdr.2007.039.
The efficacy and safety of tesaglitazar (0.5 and 1 mg) and pioglitazone (15, 30 and 45 mg) were compared in a 24-week, randomised, double-blind study in 1,707 patients with type 2 diabetes mellitus. Tesaglitazar 1 mg was non-inferior to pioglitazone 45 mg for change from baseline in glycosylated haemoglobin (HbA1C) at 24 weeks (difference: -0.056 [95% confidence intervals -0.161, 0.049], pNI<0.001 for non-inferiority hypothesis). Tesaglitazar 1 mg improved triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and non-HDL-C levels compared with all pioglitazone doses at 24 weeks (p<0.001). Low-density lipoprotein cholesterol (LDL-C) was lower with tesaglitazar for all pioglitazone comparisons (p<0.05), except for tesaglitazar 0.5 mg versus pioglitazone 15 mg. Tesaglitazar 1 mg decreased LDL particle number, when compared with all pioglitazone doses (p<0.01). Both agents increased body weight and peripheral oedema in a dose-dependent manner, but only tesaglitazar increased serum creatinine. In summary, tesaglitazar provided similar glycaemic control to pioglitazone, was associated with significant improvement in lipid and lipoprotein variables, and increased serum creatinine in a dose-dependent manner.
在一项针对1707例2型糖尿病患者开展的为期24周的随机双盲研究中，比较了替格列扎（0.5毫克和1毫克）与吡格列酮（15毫克、30毫克和45毫克）的疗效和安全性。在24周时，就糖化血红蛋白（HbA1C）相对于基线的变化而言，替格列扎1毫克不劣于吡格列酮45毫克（差异：-0.056 [95%置信区间-0.161，0.049]，非劣效性假设的pNI<0.001）。在24周时，与所有剂量的吡格列酮相比，替格列扎1毫克改善了甘油三酯（TG）、高密度脂蛋白胆固醇（HDL-C）和非HDL-C水平（p<0.001）。与所有吡格列酮剂量比较时，替格列扎组的低密度脂蛋白胆固醇（LDL-C）较低（p<0.05），但替格列扎0.5毫克与吡格列酮15毫克比较时除外。与所有剂量的吡格列酮相比，替格列扎1毫克降低了LDL颗粒数量（p<0.01）。两种药物均以剂量依赖性方式增加体重和外周水肿，但只有替格列扎增加血清肌酐。总之，替格列扎提供了与吡格列酮相似的血糖控制，与脂质和脂蛋白变量的显著改善相关，并以剂量依赖性方式增加血清肌酐。
