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Article Abstract
Aim: This study aimed to evaluate the relationships between the pharmacokinetics of tolvaptan and its metabolites (DM-4103 and DM-4107) and liver injury in heart failure patients, using relevant laboratory test values and markers of hepatocyte injury and biliary cholestasis.
Method: The plasma concentrations of tolvaptan, DM-4103, and DM-4107 were determined using LC-MS/MS in 51 Japanese heart failure patients. The relationships between the concentrations and the N-terminal fragment of pro-B-type natriuretic peptide (NT-proBNP), AST, and ALT were assessed. K18 and glutamate dehydrogenase as a marker of liver injury and CP-I and CP-III as indicators of OATP activity were also determined.
Results: The median concentrations of tolvaptan, DM-4103, and DM-4107 were 16.2, 287, and 38.0 ng/mL, respectively. AST, ALT, and T-Bil were significantly decreased after tolvaptan administration. They were negatively correlated with tolvaptan concentration. AST was also negatively correlated with DM-4107 concentration. CP-III was positively correlated with DM-4103 concentration; however, CP-I was negatively correlated with DM-4103 concentration. K18 and glutamate dehydrogenase were not correlated with tolvaptan concentration.
Conclusion: Low-dose tolvaptan did not cause liver injury. Pharmacokinetics of tolvaptan may be associated with potential amelioration of liver function in heart failure patients.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11987637 | PMC |
| http://dx.doi.org/10.1016/j.toxrep.2025.102009 | DOI Listing |
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