Effect of Empagliflozin On Liver Enzymes of Patients In Non-Alcoholic Steatohepatitis In Type 2 Diabetes Mellitus

Abstract

OBJECTIVES To assess the effect of 10 mg and 25 mg once daily Empagliflozin on liver enzymes of patients of non-alcoholic steatohepatitis in patients of type 2 diabetes mellitus (T2DM). METHODOLOGY The study design was open labelled, uncontrollerandomized clinical trial. Thirty three adult patients of Type 2 diabetes mellitus (T2DM) who were already on 2000 mg of metformin and 100 mg of Sitagliptin and were having suboptimal glycemic control (HBA1C > 7% <12%), had elevated Alanine Transaminase (ALT) levels and had ultrasonographic features consistent with non-alcoholic fatty liver disease (NAFLD) were randomized to three groups. One group received 10 mg Empagliglozin as add-on treatment (Group A), the second group received 25 mg of Empagliflozin (Group B) as an additional treatment, and the third group continued with the previous medications without any additional treatment (Group C). HbA1C levels and ALT levels of all the three groups were taken at baseline and at 12 weeks. RESULTS Total patients and their mean ages in group A, B and C were 10, 12 and 11, and 52.40 ±4.24 years, 52.42 ± 5.27 years and 52.34 ± 4.37 years, respectively. There was a statistically significant (p > 0.00) decrease mean ALT levels in Group A and B both 12 weeks post treatment as compared to pre-treatment levels. In group C, however, there was no statistically significant decrease in ALT levels after 12 weeks of follow up.CONCLUSION Empagliflozin in both 10mg and 25 mg once daily doses cause statistically significant reduction in ALT levels in patients with NASH associated with T2DM.