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A Single-Dose Pharmacokinetic Study of Lasofoxifene in Healthy Volunteers and Subjects With Mild and Moderate Hepatic Impairment

From Pfizer Inc, Ann Arbor, Michigan.

Lasofoxifene, a selective estrogen receptor modulator for osteoporosis management, is metabolized primarily by hepatic oxidation and conjugation. This study compared the pharmacokinetics of 0.25 mg lasofoxifene in subjects with mild (Child-Pugh grade A, n = 6) or moderate (Child-Pugh grade B, n = 6) hepatic impairment and healthy volunteers (n = 6). Analysis of variance was used to calculate 90% confidence intervals for the ratios (impaired/healthy) of least squares mean log maximum plasma concentration (C_max) and area under the curve (AUC) values. Lasofoxifene pharmacokinetics was similar between healthy and mild hepatic impairment subjects: ratios of C_max and AUC from 0 to infinity (AUC_[0-]) were 101% (75.0-138) and 95.5% (77.9-117), respectively. In subjects with moderate hepatic impairment, ratios of C_max and AUC_[0-] were 121% (89.6-165) and 138% (112-169), respectively; mean terminal half-life was 252 hr compared to 193 hr in healthy subjects. Dose adjustment should not be required for subjects with mild to moderate hepatic impairment.

Key Words: Lasofoxifene • osteoporosis • pharmacokinetics • hepatic impairment

Address for reprints: Candace Bramson, MD, Pfizer Global Research and Development, 2800 Plymouth Road, Ann Arbor, MI 48105.

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This article has been cited by other articles:

				R. J. Fountaine, Y. Nishizawa, G. Wei, L. Dogolo, A. Calcagni, and M. J. Gardner Clinical pharmacology of lasofoxifene in Japanese and white postmenopausal women. J. Clin. Pharmacol., June 1, 2006; 46(6): 693 - 699. [Full Text] [PDF]