Empagliflozin add-on therapy is superior to metformin monotherapy in diabetic patients with NAFLD: An open-label, single-center, pilot clinical trial

Background The prevalence of non-alcoholic fatty liver disease (NAFLD), which is characterized by hepatic steatosis, inflammation, and advanced fibrosis, is high among type-2 diabetes mellitus (T2DM) patients. Empagliflozin (EMPA), a sodium-glucose cotransporter-2 inhibitor, has been well established to improve glycemic status in T2DM. However, evidence of the desirable effects of EMPA, when added to the standard treatment in diabetics with coexisting NAFLD, has yet to be determined. Objective The main objective of the current study is to explore the benefits of EMPA on hepatic fat content in patients with T2DM and NAFLD, who received metformin (MET) monotherapy. Methods In this open-label clinical trial study, 60 patients with T2DM and NAFLD were assigned to either the MET + EMPA or MET group in an up-titrated manner for 24 weeks. Anthropometric characteristics, blood glucose indices, lipid profile, liver enzymes, and steatosis grades were measured at baseline and 24 weeks after the intervention. Results The results showed that in patients with a mean age of 53.26 +/- 7.64 who received MET+ EMPA, all the parameters had a greater decrease than the MET group. In addition, the reduction of FBS, BS, HbA1C, TG, and ALT had a statistically significant difference between the two groups after 24 weeks follow-up (p < 0.05). Notably, in the MET+ EMPA group, there was a substantial improvement in steatosis grades based on the fibroscan and ultrasound modality results. Conclusion The EMPA add-on therapeutic schedule in uncontrolled T2DM patients with NAFLD significantly ameliorated steatosis stages, liver function, anthropometric features, and biochemical parameters.