Diabetologia · 2026
Comparative hepatic effectiveness of empagliflozin vs dapagliflozin among individuals with type 2 diabetes and metabolic dysfunction-associated steatotic liver disease.
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Kim Suyeon, Ko Hwa Yeon, Hong Bin, Kim Ju Hwan, Bea Sungho, Bae Jae Hyun, Cho Young Min, Chang Yoosoo, Byrne Christopher D, Shin Ju-Young
Аннотация
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 <30) and decompensated hepatic events (ascites, variceal bleeding, hepatic failure, liver transplantation). After 1:1 propensity score matching, HRs and 95% CIs were estimated using Cox models.
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.
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 <30) and decompensated hepatic events (ascites, variceal bleeding, hepatic failure, liver transplantation). After 1:1 propensity score matching, HRs and 95% CIs were estimated using Cox models.
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.