AIMS: 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. CONCLUSION: Exposure to raloxifene was twice as high in males with renal impairment compared with healthy subjects.
AIMS: 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. CONCLUSION: Exposure to raloxifene was twice as high in males with renal impairment compared with healthy subjects.
Authors: J A Dodge; C W Lugar; S Cho; L L Short; M Sato; N N Yang; L A Spangle; M J Martin; D L Phillips; A L Glasebrook; J J Osborne; C A Frolik; H U Bryant Journal: J Steroid Biochem Mol Biol Date: 1997-04 Impact factor: 4.292
Authors: B T Gufford; J T Barr; V González-Pérez; M E Layton; J R White; N H Oberlies; M F Paine Journal: CPT Pharmacometrics Syst Pharmacol Date: 2015-11-28
Authors: Zhuo Zhang; Jörg W Bartsch; Julia Benzel; Ting Lei; Christopher Nimsky; Benjamin Voellger Journal: FEBS Open Bio Date: 2020-10-26 Impact factor: 2.792