Effect of Empagliflozin on Liver Steatosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver Disease Without Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial
Even though there is enough knowledge about the increasing prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) and co-morbidities associated with it, there is a lack of appropriate prevention programs and treatment interventions. Previous studies have concluded the beneficial effects of Sodium-Glucose co-transporter 2 (SGLT2) inhibitors on liver fat content in patients with T2DM and NAFLD. However, the effects of SGLT2 inhibitors in a non-diabetic patient with NAFLD is unknown. The author Taheri and colleagues (2020) conducted a study titled “Effect of Empagliflozin on Liver Steatosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver Disease Without Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial” published on SpringerLink. The summary of the study is below:
Objective:
To investigate the effects of empagliflozin on liver steatosis and fibrosis in a non-diabetic patient with NAFLD.
Method:
It is a randomized, double-blind, placebo-controlled clinical trial, where participants with NAFLD were randomly assigned to empagliflozin (10 mg/day) or placebo for 24 weeks. Using transient elastography, hepatic steatosis, and fibrosis were assessed to measure the Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM). The change in CAP score at 24 weeks was the primary outcome of the study.
Findings:
The findings suggest that CAP scores can detect any significant changes in the measured outcomes by following a strict criterion. No association was found between changes in CAP and BMI. It suggests that improvement in liver dysfunction and steatosis with dapagliflozin treatment doesn’t involve weight loss in its mechanism. On the other hand, on assessing body composition using DXA, a decrease in skeletal muscle index (SMI), an increase in weight reduction, and BMI is found in the empagliflozin group. The findings suggest a decrease in AST, ALT, liver stiffness measurement (LSM), hepatic fibrosis, insulin, and glucose level in the empagliflozin group. Thus, empagliflozin can be a beneficial treatment approach for patients with NAFLD without T2DM.
Limitation:
Some limitations acknowledged by the investigators were that the study did not perform a liver biopsy as the gold standard method to evaluate the status of NAFLD. Additionally, the usage of conventional CAP cutoffs to include eligible participants in this study. Moreover, the study uses recently introduced higher cutoffs in biopsy-based comparative studies for steatosis detected by transient elastography.
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