AIMS: This open-label, parallel-group study investigated the effect of various 
degrees of hepatic impairment on the pharmacokinetics, safety and tolerability 
of the sodium glucose cotransporter 2 inhibitor empagliflozin.
METHODS: Thirty-six subjects [8 each with mild, moderate or severe hepatic 
impairment (Child-Pugh classification), and 12 matched controls with normal 
hepatic function] received a single 50 mg dose of empagliflozin.
RESULTS: Empagliflozin was rapidly absorbed. After reaching peak levels, plasma 
drug concentrations declined in a biphasic fashion. Compared with subjects with 
normal hepatic function, geometric mean ratios (90% confidence interval) of 
AUC(0-∞) and C(max) were 123.15% (98.89-153.36) and 103.81% (82.29-130.95), 
respectively, in patients with mild hepatic impairment, 146.97% (118.02-183.02) 
and 123.31% (97.74-155.55), respectively, in patients with moderate hepatic 
impairment, and 174.70% (140.29-217.55) and 148.41% (117.65-187.23), 
respectively, in patients with severe hepatic impairment. Adverse events, all 
mild or moderate in intensity, were reported in three subjects with moderate 
hepatic impairment, two subjects with severe hepatic impairment and six subjects 
with normal hepatic function.
CONCLUSIONS: Empagliflozin was well tolerated in subjects with hepatic 
impairment. Increases in empagliflozin exposure were less than twofold in 
patients with hepatic impairment; therefore no dose adjustment of empagliflozin 
is required in patients with hepatic impairment.