nintedanib and Liver-Diseases

A meta-analysis of the risk of selected gastrointestinal and hepatic toxicities associated with nintedanib has been conducted.. Randomized Phase II/III trials of cancer patients on nintedanib; describing events of diarrhea, vomiting, elevated ALT and elevated AST constituted the eligible studies.. The odds ratio for high-grade diarrhea was 3.76 (95% CI: 1.42-9.96; p = 0.008); high-grade vomiting: 1.38 (95% CI: 0.76-2.51; p = 0.28); high-grade elevated ALT: 4.36 (95% CI: 2.14-8.85; p < 0.0001); high-grade elevated AST: 6.96 (95% CI: 4.09-11.85; p < 0.00001).. Nintedanib-based regimens are associated with a higher risk of high-grade diarrhea, elevated ALT and elevated AST. Moreover, there is a proportional relationship between nintedanib dose and the risk of elevated transaminases.

Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Gastrointestinal Diseases; Humans; Incidence; Indoles; Liver Diseases; Neoplasms; Odds Ratio; Population Surveillance; Risk; Severity of Illness Index

Nintedanib is an intracellular inhibitor of tyrosine kinases used in the treatment of non-small cell lung cancer and idiopathic pulmonary fibrosis (IPF). This phase 1 open-label study investigated the influence of mild and moderate hepatic impairment on the pharmacokinetics (PK), safety, and tolerability of nintedanib following oral administration of a single 100-mg dose. Subjects with hepatic impairment classified as Child-Pugh A (mild hepatic impairment) or Child-Pugh B (moderate hepatic impairment) were eligible. The control group comprised healthy matched subjects. Primary end points were C

Topics: Aged; Female; Humans; Indoles; Liver Diseases; Male; Middle Aged; Protein Kinase Inhibitors