Pharmacokinetics and Safety of Azilsartan Medoxomil in Mild to Moderate Hepatic Impairment


eMediNexus    22 January 2018

Azilsartan medoxomil, a potent angiotensin II receptor blocker, is known to decrease blood pressure in a dose-dependent manner. A recent study, published in the Journal of Clinical Pharmacology, evaluated the effect of mild to moderate hepatic impairment on the pharmacokinetics of AZL and its major metabolite. This single-center, open-label, phase 1 parallel-group study investigated the single-dose (day 1) and multiple-dose (days 4-8) - 40 mg - pharmacokinetics of AZL and the major metabolite, M-II, in 16 subjects with mild and moderate hepatic impairment by Child-Pugh classification (n = 8 per group) and 16 matched subjects based on age, sex, race, weight, and smoking status. Mild or moderate hepatic impairment did not cause clinically meaningful increases in exposure to AZL and M-II. Mild or moderate hepatic impairment seemed to have no clinically meaningful effect on the plasma protein binding of AZL and M-II. Single and multiple doses of AZL-M were well tolerated in all subject groups. It was deduced that no dose adjustment of AZL-M is required for subjects with mild and moderate hepatic impairment.

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