Efficacy and safety of #linagliptin in type 2 #diabetes patients with self-reported #hepatic disorders: A retrospective pooled analysis of 17 randomized, double-blind, placebo-controlled clinical trials

Liver disease is highly prevalent among people with type 2 diabetes mellitus (T2DM). We evaluated the dipeptidyl peptidase-4 inhibitor linagliptin in subjects with T2DM and hepatic disorders..

..Of the 7009 participants (56% white, 39% Asian), 574 had hepatic disorders, most commonly hepatic steatosis (60%). At week 24, adjusted mean ± standard error (SE) change in HbA1c from baseline in those with hepatic disorders was − 0.75% ± 0.05 with linagliptin and − 0.20% ± 0.08 with placebo [treatment difference: − 0.54% (95% confidence interval −0.72 to − 0.36); P < .0001]. There was no significant difference in HbA1c reduction between subjects with or without baseline hepatic disorders (P = .4042). Among subjects with hepatic disorders, 13.5% and 14.8% of the linagliptin and placebo groups, respectively, reported drug-related adverse events while 10.4% and 15.9%, respectively, reported hypoglycemia. Overall, adverse event rates were similar in individuals with or without hepatic disorders.

This large pooled analysis suggests that linagliptin is effective and well tolerated in people with T2DM and liver disease.