Objective: To investigate the effects of dapagliflozin on liver steatosis and fibrosis evaluated in patients with type 2 diabetes and nonalcoholic fatty liver disease (NAFLD).
Research Design and Methods: In a randomized, active-controlled, open-label trial, 57 patients with type 2 diabetes and NAFLD were randomized to a dapagliflozin (5 mg/day) group (n=33) or to the control group (n=24) and were treated for 24 weeks. Hepatic steatosis and fibrosis were assessed by using a transient elastography (FibroScan) to measure the controlled attenuation parameter (CAP) and liver stiffness measurement (LSM), respectively.
Results: At baseline, LSM was positively correlated with several markers and scoring systems for liver fibrosis in a total of 57 patients with T2D and NAFLD. In week 24, CAP showed a significant decrease from 314±61 to 290±73 dB/m (P=0.0424) in the dapagliflozin group, while there was no significant change in the control group. In addition, LSM tended to decrease from 9.49±6.05 kPa to 8.01±5.78 kPa in the dapagliflozin group. In 14 patients from this group with LS values ≥8.0 kPa, indicating significant liver fibrosis, LSM decreased significantly from 14.7±5.7 to 11.0±7.3 kPa (P=0.0158). Furthermore, serum alanine aminotransferase and γ-glutamyltranspeptidase levels decreased in the dapagliflozin group, but not in the control group, and visceral fat mass was significantly reduced in the dapagliflozin group.
Conclusions: Based on these findings, the SGLT2 inhibitor dapagliflozin improves liver steatosis in parallel with a decrease of liver enzymes in patients with type 2 diabetes and NAFLD, and attenuates liver fibrosis in only patients with significant liver fibrosis. (UMIN000022155)
Y. Aso: Research Support; Self; Ono Pharmaceutical Co., Ltd. T. Jojima: None. T. Iijima: None. I. Usui: None.