Abstract
Aims/hypothesis
While both empagliflozin and dapagliflozin are known to improve hepatic steatosis and liver enzyme levels, robust phase 3 trial evidence for improving steatohepatitis and fibrosis is currently exclusive to dapagliflozin. Therefore, a head-to-head comparison between two agents is warranted, to compare the hepatic outcomes between empagliflozin and dapagliflozin in individuals with metabolic dysfunction-associated steatotic liver disease (MASLD).Methods
Using nationwide Korean claims data, we constructed a new-user cohort of adults with MASLD, defined as having type 2 diabetes and a fatty liver index (FLI) ≥60, who initiated empagliflozin or dapagliflozin between May 2016 and December 2023. Outcomes of interest were FLI-defined MASLD regression (achieving FLI Results
Among 265,098 new users of empagliflozin and dapagliflozin, 101,487 pairs were 1:1 propensity score-matched (mean age 54.3 years; male 71.3%). Compared with dapagliflozin, empagliflozin was associated with a marginally higher likelihood of FLI-defined MASLD regression (HR 1.06; 95% CI 1.00, 1.11). The risk of decompensated hepatic events was comparable (HR 0.99; 95% CI 0.94, 1.03). Dose-stratified analyses yielded consistent findings in both FLI-defined MASLD regression (low-dose: HR 1.19; 95% CI 0.77, 1.83; high-dose: 1.14; 1.01, 1.28) and decompensated hepatic events (low-dose: 0.95; 0.74, 1.23; high-dose: 1.04; 0.93, 1.15).Conclusions/interpretation
Among individuals with MASLD, no significant differences were observed between empagliflozin and dapagliflozin in the risk of decompensated hepatic events.