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Pharmacokinetics of Eplerenone After Single and Multiple Dosing in Subjects With and Without Renal Impairment

From the Department of Pharmacal Sciences, Harrison School of Pharmacy, Auburn University, Auburn, Alabama (Dr Ravis); Pharmacia Laboratories, Stokie, Illinois (Ms Reid, Dr Roniker, Dr Tolbert); and Division of Nephrology, Medical College of Virginia of Virginia Commonwealth University, Richmond (Dr Sica).

The influence of renal impairment on the pharmacokinetics of eplerenone following single and multiple dosing was evaluated. Subjects (n = 64) were stratified based on creatinine clearance values as follows: renal impairment (mild, moderate, severe), hemodialysis, and normal matches. Subjects received a single dose of eplerenone 100 mg on day 1 and then received 100 mg once daily on days 3 to 8. There were no statistically significant differences between any of the renal impairment groups and their matched-normal groups for area under the curve (AUC), C_max, or CL/F or CL/F/WT following either single or multiple dosing (P .093). The inactive metabolite and inactive ring-opened form displayed greater AUCs in renal impairment. Hemodialysis removed approximately 10% of the eplerenone dose. Eplerenone 100 mg once daily was well tolerated in all groups. Considering that renal function had no significant effects on eplerenone CL/F and that eplerenone metabolites are inactive, no dose adjustment appears necessary in patients with renal dysfunction.

Key Words: Eplerenone • renal disease • pharmacokinetics • hemodialysis • renal impairment

Address for reprints: William R. Ravis, Pharmacal Sciences, 407 Walker Building, Auburn University, AL 36849.

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