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No azilsartan dose adjustments required based on age, sex, or race

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eMediNexus    29 January 2018

Following oral dosing, azilsartan medoxomil (AZL-M) is known to be quickly hydrolyzed to azilsartan (AZL). A study, published in Clinical Pharmacokinetics, investigated the effects of age, sex, and race on the pharmacokinetics of AZL-M in healthy subjects, and also studied its safety and tolerability. Sixty-one healthy adults were recruited in the phase I, single-blind, randomized placebo-controlled study. Participants were stratified by age (18-45 vs. 65-85 years), sex, and race and were given oral AZL-M 60 mg (3 × 20 mg capsules) or placebo as a single dose on Day 1 and consecutive daily doses from Days 4-8 (6:2 ratio for AZL-M:placebo per group). Pharmacokinetics were evaluated for AZL-M patients only on Days 1-3 and 8-9 and safety/tolerability was evaluated. Age, sex, and race had no significant impact on AZL exposures after single or multiple dosing. Pharmacokinetic parameters were noted to be similar between Days 1 and 8 for each age, sex, and race subgroup. The frequency of adverse events was similar for AZL-M (32%) and placebo (29%). It was concluded that no AZL-M dose adjustments are required on the basis of age, sex, or race (black/white).

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