Why carry out this study?

A frequently underappreciated comorbidity of type 2 diabetes mellitus (T2DM) is non-alcoholic fatty liver disease (NAFLD). Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been shown to reduce serum levels of alanine and aspartate aminotransferase (ALT and AST, respectively) in patients with T2DM with and without NAFLD.

The aim of this pooled, post hoc analysis of seven randomized, double-blind phase 3 VERTIS trials was to assess the impact of ertugliflozin on liver enzymes in patients with T2DM.

What was learned from the study?

Ertugliflozin reduced serum ALT and AST levels after 52 weeks of treatment compared with the non-ertugliflozin treatment group (placebo, glimepiride, sitagliptin), similar to results obtained with other SGLT2 inhibitors. The reduction was greatest in patients with higher baseline ALT and AST levels. No significant differences were observed between treatment groups in the Fibrosis-4 Index.

Changes in ALT and AST showed a weak but statistically significant association with changes in glycated hemoglobin (HbA1c) and body weight in all treatment groups at week 52, suggesting that these changes in hepatic transaminases are partially accounted for by reductions in body weight and HbA1c.