Outcomes of empagliflozin in nondiabetic fatty liver patients: A randomized controlled trial.

Objectives: Metabolic fatty liver disease is a common disease with numerous health risks. Life modification remains the primary treatment. Previous studies have shown that the sodium‒glucose cotransporter has a positive effect on improving fatty liver in individuals with diabetes mellitus, but it has not been extensively studied in nondiabetic patients with fatty liver. The aim of this study was to assess the immediate effects of empagliflozin in treating nondiabetic metabolic fatty liver disease.

Methods: We conducted a prospective parallel-group open-label study on fifty-five nondiabetic metabolic fatty liver patients. Patients were randomly assigned to two groups: twenty-two patients received lifestyle advice alone (L-arm), and thirty-three patients received lifestyle advice plus empagliflozin 10 mg daily (LE-arm). After 6 months, non-invasive elastography (fibro-scan) was used to check for changes in hepatic steatosis and fibrosis. Body mass index, waist circumference, arterial blood pressure, glycated haemoglobin, and lipid profiles were also used to measure metabolic outcomes.

Results: The LE-arm showed a mean CAP reduction of 38 dB/m compared to 8 dB/m in the L-arm (p = 0.001). Moreover, there was a slight improvement in liver fibrosis, as well as improvements in metabolic measures such as blood pressure (p value 0.034), waist circumference (p value 0.01), and weight reduction (2.5 kg vs. 1 kg, p value 0.022).

Conclusion: Along with lifestyle changes, empagliflozin may improve hepatic steatosis and the metabolic profile in nondiabetic fatty liver patients. However, conducting a longer term risk‒benefit analysis requires more research.

Clinical trial registration: NCT05694923 at 2023-01-19.