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. 2019 Feb 15;10(2):114–132. doi: 10.4239/wjd.v10.i2.114

Table 2.

Randomised controlled trials

S. No Ref. Inclusion criteria Age (yr) Male gender Intervention arm Control arm Follow-up duration Primary outcome
1 Kuchay et al[11], 2018 Age > 20 yr, hepatic steatosis (MRI-PDFF > 6%), HbA1c > 7.0% to < 10.0% Intervention arm: 50.7 (12.8) Intervention arm: 16 (64%) Standard treatment + Empagliflozin 10 mg daily (n = 25) Standard treatment (n = 25) 20 wk Change in liver fat content by MRI-PDFF
Control arm: 49.1 (10.3) Control arm: 17 (68%)
2 Ito et al[12], 2017 Age 20-75 yr, HbA1c 7.0–11.0%, BMI < 45 kg/m2, On diet and exercise therapy alone or with oral hypoglycaemic agents other than SGLT-2 inhibitors and thiazolidinediones and/or insulin, NAFLD, findings suggesting hepatic steatosis and hepatic dysfunction on clinical laboratory tests or on imaging studies (e.g., computed tomography or ultrasound) Pioglitazone arm: 59.1 (9.8) Pioglitazone arm: 18 (53%) Ipragliflozin 50 mg daily (n = 32) Pioglitazone 15-30 mg daily (n = 34) 24 wk Change in L/S attenuation ratio
Ipragliflozin arm: 57.3 (12.1) Ipragliflozin arm: 14 (44%)
3 Shibuya et al[13], 2018 Fatty liver diagnosed on the basis of computed tomography or abdominal sonography, HbA1c 6.0%–10.0%, age 20–70 yr Luseogliflozin arm: 51 (47-62) Luseogliflozin arm: 10 (62.5%) Luseogliflozin 2.5 mg daily (n = 16) Metformin 1.5 g daily (n = 16) 24 wk Change in L/S attenuation ratio
Metformin arm: 60 (53-66) Metformin arm: 8 (50%)
4 Eriksson et al[14], 2018 Age 40–75 yr, treated with a stable dose of metformin or sulfonylurea alone or in combination for at least 3 mo, MRI-PDFF > 5.5%, BMI 25–40 kg/m2 Dapagliflozin arm: 65 (6.5) Dapagliflozin arm: 16 (76.2%) Dapagliflozin 10 mg daily (n = 21) or Omega 3-carboxylic acid 4 g daily (n = 20) or Combination (n = 22) Placebo (n = 21) 12 wk Change in liver fat content by MRI-PDFF
Omega 3-carboxylic acid arm: 66.2 (5.9) Omega 3-carboxylic acid arm: 11 (55%)
O + D arm: 65(5.4) O + D arm: 15 (68.2%)
Placebo arm: 65.6 (6.1) Placebo arm: 17 (81%)

MRI-PDFF: Magnetic resonance imaging-derived proton density fat fraction; L/S: Liver/spleen; O + D: Omega 3-carboxylic acid + Dapagliflozin; SGLT-2: Sodium glucose cotransporter-2; NAFLD: Non-alcoholic fatty liver disease.

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