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Ipragliflozin Additively Ameliorates Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes Controlled with Metformin and Pioglitazone: A 24-Week Randomized Controlled Trial

1
Division of Endocrinology, Department of Internal Medicine, Keimyung University School of Medicine, Daegu 42601, Korea
2
Division of Endocrinology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul 03722, Korea
3
Institue of Endocrine Research, Yonsei University College of Medicine, Seoul 03722, Korea
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2020, 9(1), 259; https://doi.org/10.3390/jcm9010259
Received: 26 December 2019 / Revised: 14 January 2020 / Accepted: 15 January 2020 / Published: 18 January 2020
(This article belongs to the Special Issue Pathophysiology and Complications of Type 2 Diabetes Mellitus)
Despite the benefits of pioglitazone in the treatment of non-alcoholic fatty liver disease (NAFLD), many treated patients continue to experience disease progression. We aimed to investigate the additive effect of ipragliflozin on NAFLD in patients with type 2 diabetes treated with metformin and pioglitazone. In this 24-week randomized controlled trial, 44 patients with type 2 diabetes and comorbid NAFLD were either randomized to receive 50 mg/day of ipragliflozin as an add-on treatment (n = 29) or maintained on metformin and pioglitazone (n = 15). The fatty burden was assessed using the fatty liver index, NAFLD liver fat score, and controlled attenuation parameter (CAP). Changes in fat and muscle depots were measured by dual-energy x-ray absorptiometry and abdominal computed tomography scans. The enrolled patients were relatively controlled (mean baseline glycated hemoglobin of 6.6% ± 0.6%) and centrally obese (mean waist circumference of 101.6 ± 10.9 cm). At week 24, patients in the ipragliflozin add-on group exhibited reduced hepatic fat content (fatty liver index: −9.8 ± 1.9, p = 0.002; NAFLD liver fat score: −0.5 ± 0.2, p = 0.049; CAP: −8.2 ± 7.8 dB/m2, p = 0.133). Ipragliflozin add-on therapy also reduced whole-body visceral fat and the ratio of visceral to subcutaneous fat (change in whole-body visceral fat: −69.6 ± 21.5 g; change in abdominal visceral fat: −26.2 ± 3.7 cm2; abdominal visceral to subcutaneous fat ratio: −0.15 ± 0.04; all p < 0.05). In conclusion, ipragliflozin treatment significantly ameliorates liver steatosis and reduces excessive fat in euglycemic patients with type 2 diabetes and NAFLD taking metformin and pioglitazone. View Full-Text
Keywords: non-alcoholic fatty liver disease; obesity; type 2 diabetes mellitus; sodium/glucose cotransporter 2 inhibitor non-alcoholic fatty liver disease; obesity; type 2 diabetes mellitus; sodium/glucose cotransporter 2 inhibitor
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Han, E.; Lee, Y.-H.; Lee, B.-W.; Kang, E.S.; Cha, B.-S. Ipragliflozin Additively Ameliorates Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes Controlled with Metformin and Pioglitazone: A 24-Week Randomized Controlled Trial. J. Clin. Med. 2020, 9, 259.

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