Changes in factors from baseline to 24 weeks in the pioglitazone and tofogliflozin groups
| Pioglitazone group (n=17) | Tofogliflozin group (n=21) | Baseline difference pioglitazone versus tofogliflozin group | Treatment effect pioglitazone versus tofogliflozin group | ||||||
| Baseline | 24-week treatment | P value | Baseline | 24-week treatment | P value | P value | Mean difference (95% CI) | P value | |
| Hepatic steatosis and liver test | |||||||||
| MRI-PDFF (%) | 18.04±7.46 | 10.50±4.25 | <0.0001* | 17.28±5.67 | 13.16±6.47 | 0.0042* | 0.7218 | −3.4 (−7.2 to 0.36) | 0.0750 |
| AST (IU/mL) | 62.4±7.54 | 34.5±14.1 | 0.0014* | 54.0±6.78 | 38.2±22.9 | 0.0096* | 0.4097 | −12.2 (−30.3 to 5.9) | 0.1791 |
| ALT (IU/mL) | 74.9±22.7 | 41.1±10.1 | <0.0001* | 84.0±39.6 | 60.7±9.1 | 0.0115* | 0.4106 | −10.6 (−31.3 to 10.1) | 0.3062 |
| ALP (IU/mL) | 261.2±86.3 | 212.2±12.2 | 0.0012* | 248.9±70.7 | 232.2±11.0 | 0.0807 | 0.6311 | −32.3 (−62.9 to 1.7) | 0.0389* |
| GGT (IU/mL) | 97.6±19.2 | 50.9±38.2 | 0.0283* | 66.2±17.2 | 48.9±34.9 | 0.0093* | 0.2320 | −29.3 (−67.1 to 8.5) | 0.1244 |
| CHE (IU/mL) | 377.6±48.5 | 367.1±11.6 | 0.0846 | 379.4±41.9 | 383.0±10.5 | 0.6418 | 0.9035 | −14.1 (−34.3 to 6.1) | 0.1654 |
| Hepatic fibrosis | |||||||||
| MRE-LSM (kPa) | 3.42±1.46 | 3.08±1.08 | 0.0226* | 3.03±0.84 | 2.89±0.89 | 0.1447 | 0.3041 | −0.2 (−0.5 to 0.1) | 0.2154 |
| WFA+-M2BP (COI) | 0.96±0.12 | 0.78±0.36 | 0.0092* | 0.80±0.10 | 0.66±0.34 | 0.0130* | 0.3122 | −0.06 (−0.19 to 0.06) | 0.3164 |
| Type IV collagen 7S (ng/mL) | 4.09±1.34 | 4.02±1.03 | 0.8480 | 4.34±1.01 | 4.01±0.88 | 0.2577 | 0.5119 | 0.2 (−0.4 to 0.8) | 0.4810 |
| FIB-4 index | 2.12±1.82 | 1.74±0.96 | 0.1595 | 1.48±0.60 | 1.33±0.63 | 0.1483 | 0.1319 | 0.3 (−0.3 to 0.8) | 0.3948 |
| Glycemic and metabolic parameters | |||||||||
| FPG (mg/dL) | 144.2±41.1 | 123.8±27.0 | 0.0564 | 144.5±50.2 | 142.0±49.4 | 0.8289 | 0.9843 | −17.8 (−49.5 to 13.8) | 0.2610 |
| HbA1c ((%(mmol/mol))) | 7.09±0.19 (54.0±7.3) | 6.40±0.18 (46.4±6,6) | 0.0003* | 7.22±0.17 55.4±9.6) | 6.82±0.16 (51.1±8.9) | 0.0013* | 0.6320 | −0.2 (−0.7 to 0.1) (−3.3 (−7.3 to 0.7) | 0.1052 |
| Total cholesterol (mg/dL) | 195.7±35.6 | 200.6±35.7 | 0.2724 | 188.9±33.0 | 200.0±42.7 | 0.2179 | 0.5458 | −6.2 (−27.4 to 15.0) | 0.5560 |
| Triglycerides (mg/dL) | 160.8±57.2 | 117.8±58.5 | 0.0093* | 152.1±63.4 | 159.0±82.1 | 0.6423 | 0.6639 | −49.9 (−92.1 to -7.7) | 0.0219* |
| HDL cholesterol (mg/dL) | 54.2±16.6 | 63.9±18.9 | <0.0001* | 56.2±12.2 | 59.1±12.7 | 0.0441* | 0.6689 | 6.8 (2.3 to 11.2) | 0.0037* |
| LDL cholesterol (mg/dL) | 117.0±7.3 | 116.3±32.4 | 0.7916 | 111.4±6.5 | 114.2±32.5 | 0.7148 | 0.5722 | −3.5 (−21.0 to 14.0) | 0.6902 |
| Uric acid (mg/dL) | 5.72±0.94 | 5.49±0.90 | 0.2459 | 5.70±1.06 | 4.81±0.84 | 0.0004* | 0.9317 | 0.6 (0.1 to 1.2) | 0.0336* |
| High sensitivity CRP | 2304±2263 | 1112.6±891.2 | 0.0093* | 1544±1350 | 843.7±552.1 | 0.0209* | 0.2115 | −461.7 (−1451.5 to 528.0) | 0.3498 |
| Oxidative stress, adiponectin, and proketogenic profile | |||||||||
| Uric 8-OHdG (ng/mL) | 16.34±2.44 | 11.81±6.38 | 0.1138 | 18.58±2.18 | 9.39±5.53 | 0.0005* | 0.4972 | 4.6 (−2.7 to 11.9) | 0.2058 |
| Adiponectin (μg/mL) | 6.39±0.77 | 14.51±7.55 | 0.0003* | 5.00±0.67 | 4.86±1.46 | 0.1100 | 0.1791 | −7.3 (4.8 to 9.8) | 0.1052 |
| Acetoacetic acid (μmol/L) | 34.4±19.1 | 35.9±29.9 | 0.7466 | 21.1±22.4 | 65.4±85.0 | 0.0363* | 0.7445 | −34.9 (−75.8 to 6.1) | 0.0926 |
| 3-Hydroxybutyric acid (μmol/L) | 64.1±13.8 | 79.3±74.1 | 0.6809 | 62.6±12.0 | 136.4±187.9 | 0.0308* | 0.9349 | −65.4 (−154.9 to 24.3) | 0.1476 |
| CK-18 fragment M30 (U/L) | 586.6±376.0 | 360.0±211.3 | 0.0048* | 735.0±511.9 | 367.5±214.9 | 0.0007* | 0.3260 | 155.9 (−106.2 to 417.9) | 0.2345 |
Data are presented as mean±SD. *P<0.05
*p<0.05.
ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate transaminase; CHE, cholinesterase; CK-18, cytokeratin 18; COI, cut off index; CRP, C reactive protein; FIB-4, Fibrosis-4; FPG, fasting plasma glucose; GGT, γ-glutamyl transpeptidase; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; LDL, low density lipoprotein; LSM, liver stiffness measurement; MRE, magnetic resonance elastography; 8-OHdG, 8-hydroxy-2’-deoxyguanosine; PDFF, proton density fat fraction; WFA+-M2BP, Wisteria floribunda agglutinin-positive Mac-2 binding protein glycosylation isomer.