Daisuke Ito1,2, Satoshi Shimizu2, Kazuyuki Inoue3,2, Daigo Saito3,2, Morifumi Yanagisawa2,4, Kouichi Inukai5, Yuji Akiyama2, Yoshihiro Morimoto2, Mitsuhiko Noda3, Akira Shimada3. 1. Department of Endocrinology and Diabetes, Saitama Medical University, Saitama, Japan dito@saitama-med.ac.jp. 2. Department of Internal Medicine, Ogawa Red Cross Hospital, Saitama, Japan. 3. Department of Endocrinology and Diabetes, Saitama Medical University, Saitama, Japan. 4. Satsuki Medical Clinic, Saitama, Japan. 5. Department of Diabetes and Endocrinology, Higashiyamato Hospital, Tokyo, Japan.
Abstract
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 receiveipragliflozin 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.
RCT Entities:
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.
Authors: M G Radaelli; F Martucci; S Perra; S Accornero; G Castoldi; G Lattuada; G Manzoni; G Perseghin Journal: J Endocrinol Invest Date: 2017-11-30 Impact factor: 4.256
Authors: Jeff Y Yang; Andrew M Moon; Hannah Kim; Virginia Pate; A Sidney Barritt; Matthew J Crowley; John B Buse; Til Stürmer; Anastasia-Stefania Alexopoulos Journal: J Diabetes Complications Date: 2020-08-05 Impact factor: 2.852
Authors: E G Dorsey-Treviño; J G González-González; N Alvarez-Villalobos; V González-Nava; B M Contreras-Garza; A Díaz González-Colmenero; G Rodríguez-Tamez; F J Barrera-Flores; A M Farrell; V M Montori; R Rodriguez-Gutierrez Journal: J Endocrinol Invest Date: 2019-09-05 Impact factor: 4.256