Therapeutic outcome of dapagliflozin on various parameters in non-alcoholic fatty liver disease (NAFLD) patients

Background Body weight reduction is the first-line recommendation in NAFLD patients. Dapagliflozin has a strong potential to reduce body weight in addition to its glycemic control effect Objective To study the effect of dapagliflozin on various parameters in NAFLD type 2 diabetic patients. Methods In this randomized controlled trial, 150 type 2 diabetic patients with NAFLD diagnosed on the basis of radiological findings and deranged liver enzymes were randomly allocated into two groups. Both groups were taking tab glimepiride as a standard treatment of type 2 diabetes. Group A was given tab dapagliflozin 5–10 mg while group B was given tab placebo in addition to lifestyle modifications for a period of 12 weeks. Body weight, BMI, HbA1c, and serum aminotransferases were analyzed pre- and post-treatment using SPSS 20. Results After 12 weeks of treatment, glycemic control was improved in both study groups, i.e., dapagliflozin (FBS from 95 ± 14 to 80 ± 11 mg/dl with p = 0.003, HbAIc from 7.5 ± 4.5 to 6.4 ± 5.4% with p = 0.002) and placebo (FBS from 100 ± 9.5 to 90.5 ± 13 mg/dl with p = 0.004, HbA1c from 8.2 ± 3.5 to7.6 ± 4.2% with p = 0.006). However, the dapagliflozin group showed a significant reduction in FBS and HbA1c as compared to placebo with p value 0.006 and 0.04 respectively. Body weight was significantly reduced in the dapagliflozin group (from 90 ± 13.5 to 84 ± 11.6) as compared to the placebo group (from 85 ± 17.8 to 85.5 ± 13.7) with p = 0.002. BMI also reduced in the dapagliflozin group (from 29.5 ± 2.5 to 26.5 ± 3.5) versus the placebo group (from 31.5 ± 3.0 to 29.5 ± 4.2) with p = 0.002. There was also significant reduction in ALT in the dapagliflozin group from 69 ± 15.5 to 52 ± 12.8 versus placebo from 68 ± 20.5 with p = 0.04 and AST from 74 ± 13 to 47 ± 13.5 versus placebo from 71 ± 12.5 to 65 ± 10.5 with p = 0.02 Conclusion Dapagliflozin has a strong potential to reverse NAFLD-associated changes in type 2 diabetic patients.