Raloxifene pharmacokinetics in males with normal and impaired renal function.
OBJECTIVE
To compare raloxifene pharmacokinetics between renally impaired and healthy subjects.


METHODS
Raloxifene 120 mg was administered to 10 males with renal impairment (creatinine 2-4 mg dl(-1)) and to 10 healthy males. Data were analysed by two noncompartmental and one compartmental nonlinear regression methods.


RESULTS
The medians (95% confidence interval) of the area under the curves (AUC) were 35.1 (25.8, 74) and 20.5 (16.8, 28.0) h ng ml(-1) per mg kg(-1), P < 0.01, and of the clearances (CL/F) were 28.5 (13.5, 38.8) and 48.8 (35.8, 59.4) l h(-1) kg(-1), P < 0.01, in renally impaired and healthy subjects, respectively. 95% Confidence intervals on the differences for AUC and CL/F were 6.5-44.1 and -35.1 to -7.9, respectively.


CONCLUSIONS
Exposure to raloxifene was twice as high in males with renal impairment compared with healthy subjects.
Czock
David
D
University Hospital Ulm, Division of Nephrology, Ulm, Germany.
Keller
Frieder
F
Heringa
Mette
M
Rasche
Franz Maximilian
FM
D000328:Adult; D019540:Area Under Curve; D003404:Creatinine / Q000378:metabolism; D006207:Half-Life; D006801:Humans; D007668:Kidney / Q000378:metabolism*; D007674:Kidney Diseases / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D020849:Raloxifene Hydrochloride / Q000097:blood / Q000493:pharmacokinetics*; D020845:Selective Estrogen Receptor Modulators / Q000097:blood / Q000493:pharmacokinetics*
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride; D003404:Creatinine