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Comparison of Ipragliflozin and Pioglitazone Effects on Nonalcoholic Fatty Liver Disease in Patients With Type 2 Diabetes: A Randomized, 24-Week, Open-Label, Active-Controlled Trial
Diabetes Care ( IF 14.8 ) Pub Date : 2017-07-28 , DOI: 10.2337/dc17-0518
Daisuke Ito 1, 2 , Satoshi Shimizu 2 , Kazuyuki Inoue 1, 2 , Daigo Saito 1, 2 , Morifumi Yanagisawa 2, 3 , Kouichi Inukai 4 , Yuji Akiyama 2 , Yoshihiro Morimoto 2 , Mitsuhiko Noda 1 , Akira Shimada 1
Affiliation  

OBJECTIVE To compare the efficacy of ipragliflozin versus pioglitazone in patients with type 2 diabetes complicated by nonalcoholic fatty liver disease (NAFLD).

RESEARCH DESIGN AND METHODS In this open-label, randomized, active-controlled trial, we randomly assigned 66 patients with type 2 diabetes and NAFLD to receive ipragliflozin 50 mg (n = 32) or pioglitazone 15–30 mg (n = 34) orally once daily. The primary outcome was a change from baseline in the liver-to-spleen attenuation ratio (L/S ratio) on computed tomography at week 24.

RESULTS At week 24, the mean ± SD L/S ratio had increased by 0.22 (from 0.80 ± 0.24 to 1.00 ± 0.18) in the ipragliflozin group and 0.21 (from 0.78 ± 0.26 to 0.98 ± 0.16) in the pioglitazone group (P = 0.90). Serum aspartate and alanine aminotransferase levels, HbA1c, and fasting plasma glucose were similarly reduced in the two treatment groups. Nevertheless, body weight and visceral fat area showed significant reductions only in the ipragliflozin group compared with the pioglitazone group (P < 0.0001 and P = 0.0013, respectively). There were no serious adverse events in either group.

CONCLUSIONS Compared with pioglitazone, ipragliflozin exerts equally beneficial effects on NAFLD and glycemic control during the treatment of patients with type 2 diabetes complicated by NAFLD. Furthermore, ipragliflozin significantly reduced body weight and abdominal fat area.



中文翻译:

依格列净和吡格列酮对2型糖尿病患者非酒精性脂肪性肝病影响的比较:一项随机,24周,开放标签,主动控制的试验

目的比较伊格列净与吡格列酮在2型糖尿病合并非酒精性脂肪肝(NAFLD)患者中的疗效。

研究设计和方法在这项开放性,随机,活动,对照试验中,我们随机分配66名2型糖尿病和NAFLD患者口服ipragliflozin 50 mg(n = 32)或吡格列酮15– 30 mg(n = 34)口服每天一次。主要结果是在第24周时计算机断层扫描的肝脏与脾脏衰减比率(L / S比率)相对于基线的变化。

结果在第24周时,伊格列净组的平均±SD L / S比增加了0.22(从0.80±0.24到1.00±0.18),吡格列酮组增加了0.21(从0.78±0.26到0.98±0.16)(P = 0.90)。在两个治疗组中,血清天门冬氨酸和丙氨酸氨基转移酶水平,HbA 1c和空腹血糖水平均相似地降低。然而,与吡格列酮组相比,仅伊普列净组的体重和内脏脂肪面积显着减少(分别为P <0.0001和P = 0.0013)。两组均无严重不良事件。

结论与吡格列酮相比,依普列净在治疗2型糖尿病合并NAFLD的患者中对NAFLD和血糖控制具有同等有益的作用。此外,依普列净可显着降低体重和腹部脂肪区域。

更新日期:2017-09-08
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