HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Sign In to gain access to subscriptions and/or personal tools.

This Article Full Text Full Text (PDF) All Versions of this Article: 0091270008322035v1 48/9/1014    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Khosravan, R. Articles by Vernillet, L. Search for Related Content PubMed PubMed Citation Articles by Khosravan, R. Articles by Vernillet, L. Social Bookmarking                         What's this?

The Effect of Age and Gender on Pharmacokinetics, Pharmacodynamics, and Safety of Febuxostat, a Novel Nonpurine Selective Inhibitor of Xanthine Oxidase

From TAP Pharmaceutical Products Inc, Lake Forest, Illinois. Dr Khosravan is currently at Pfizer Global Research & Development, La Jolla Laboratories, San Diego, California. Dr Vernillet is currently at Genentech, Inc, 1 DNA Way, South San Francisco, California.

Febuxostat is a novel nonpurine selective inhibitor of xanthine oxidase, which is currently being developed for the management of hyperuricemia in patients with gout. The effect of age and gender on the pharmacokinetics, pharmacodynamics, and safety of once-daily oral febuxostat 80 mg was assessed in healthy male and female subjects after 7 days. Following multiple dosing with febuxostat, there were no statistically significant differences in the plasma or urinary pharmacokinetic or pharmacodynamic parameters between subjects aged 18 to 40 years and 65 years. Although unbound peak concentration (C_max,u) and area under the concentration-time curve (AUC_24,u) for febuxostat were higher in women as compared with men (31.5 vs 23.6 ng/mL, P .01, and 62.8 vs 53.9 ngxh/mL, P .05, for C_max,u and AUC_24,u, respectively), the differences were not considered clinically significant and could be largely accounted for by weight differences between male and female subjects. For pharmacodynamic parameters, even though the percentage decrease in serum uric acid 24-hour mean concentration was slightly greater in women than in men (59% vs 52%, P .01), this difference was not considered clinically meaningful. Febuxostat was well tolerated in male and female subjects in both age groups. Age or gender had no clinically significant effect on the pharmacokinetics, pharmacodynamics, or safety of febuxostat. Therefore, febuxostat does not require any dose adjustments based on age or gender.

Key Words: Age • febuxostat • gender • pharmacodynamics • pharmacokinetics

Address for reprints: Reza Khosravan, PhD, 10646 Science Center Drive, San Diego, CA 92121.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				N. L. Edwards Febuxostat: a new treatment for hyperuricaemia in gout Rheumatology, May 1, 2009; 48(suppl_2): ii15 - ii19. [Abstract] [Full Text] [PDF]