Article date: November 2002
By: Alfred E. Corey, Jeffrey R. Agnew, Suzanne N. Valentine, Nikhil J. Parekh, James H. Powell, Gary A. Thompson, in Volume 54, Issue 5, pages 449-452
Aims To assess the influence of severe renal impairment on azimilide pharmacokinetics.
Methods A single oral dose of 125 mg azimilide dihydrochloride was administered to subjects with normal and severely impaired renal function. Blood and urine samples were collected for 22–28 and 10 days, respectively.
Results Azimilide renal clearance decreased in subjects with renal impairment (mean 14 vs 4.8 ml h−1 kg−1, 95% confidence interval on the ratio 0.23, 0.50). However, no change in any other pharmacokinetic parameter including oral clearance (mean 109 vs 104 ml h−1 kg−1, 95% confidence interval on the ratio 0.67, 1.36) was observed.
Conclusions Since azimilide blood concentrations are essentially unaffected by renal function, an a priori dosage regimen adjustment is not required in patients with renal impairment.
DOI: 10.1046/j.1365-2125.2002.01664.x
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