Evaluation of etodolac in subjects with renal impairment

Nonsteroidal anti-inflammatory drugs have been implicated in renal impairment. The purpose of this report is to review the effect of etodolac, a new anti-inflammatory agent, on renal function and the effect of renal impairment on etodolac pharmacokinetics. Pharmacokinetic and renal function studies were conducted in normal and in renally impaired volunteers. Additionally, the renal safety of etodolac was assessed in 2,629 arthritic patients who were treated in clinical trials. The results suggest that etodolac does not affect renal function in normal individuals, nor does it exacerbate underlying renal insufficiency when administered to patients with mild to moderate renal impairment. The pharmacokinetics of etodolac are unchanged in patients on hemodialysis and in elderly patients. Furthermore, no patient was withdrawn from clinical trials for significantly abnormal renal function test values resulting from etodolac therapy alone.