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) 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 Web of Science (24) Citing Articles via Google Scholar Google Scholar Articles by Vaidyanathan, S. Articles by Dole, W. P. Search for Related Content PubMed PubMed Citation Articles by Vaidyanathan, S. Articles by Dole, W. P. Social Bookmarking                         What's this?

Pharmacokinetics, Safety, and Tolerability of the Oral Renin Inhibitor Aliskiren in Patients With Hepatic Impairment

From Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (Dr Vaidyanathan, Mr Warren, Dr Yeh); Novartis Pharma SAS, Rueil-Malmaison, France (Dr Bizot); Novartis Pharma AG, Basel, Switzerland (Dr Dieterich); and Novartis Institutes for Biomedical Research, Cambridge, Massachusetts (Dr Dole).

Aliskiren is the first in a new class of orally active, direct renin inhibitors for the treatment of hypertension. This open-label, nonrandomized, single-center, parallel-group study compared the pharmacokinetics and safety of a single 300-mg oral dose of aliskiren in patients with mild, moderate, or severe hepatic impairment to that in healthy subjects. When pooled across subgroups, there were no significant differences between patients with hepatic impairment and healthy subjects in aliskiren AUC_0- (ratio of geometric means, 1.12; 90% confidence interval, 0.85, 1.48) or C_max (mean ratio, 1.19; 90% confidence interval, 0.84, 1.68), and there was no correlation between severity of hepatic impairment and either AUC_0- or C_max. Aliskiren was well tolerated by healthy subjects and patients with hepatic impairment. In conclusion, hepatic impairment has no significant effect on the pharmacokinetics of aliskiren following single-dose administration, and dosage adjustment is unlikely to be needed in patients with liver disease.

Key Words: Aliskiren • liver • pharmacokinetics • reninangiotensin system

Address for reprints: Address for correspondence: William P. Dole, Novartis Institute for Biomedical Research, 400 Technology Square, Building 605-820, Cambridge, MA 02139.

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

This article has been cited by other articles:

				K. K. Daugherty Aliskiren Am. J. Health Syst. Pharm., July 15, 2008; 65(14): 1323 - 1332. [Abstract] [Full Text] [PDF]

				S. Ayalasomayajula, C.-M. Yeh, S. Vaidyanathan, B. Flannery, H. A. Dieterich, D. Howard, M. P. Bedigian, and W. P. Dole Effects of Aliskiren, a Direct Renin Inhibitor, on Cardiac Repolarization and Conduction in Healthy Subjects J. Clin. Pharmacol., July 1, 2008; 48(7): 799 - 811. [Abstract] [Full Text] [PDF]

				F. Waldmeier, U. Glaenzel, B. Wirz, L. Oberer, D. Schmid, M. Seiberling, J. Valencia, G.-J. Riviere, P. End, and S. Vaidyanathan Absorption, Distribution, Metabolism, and Elimination of the Direct Renin Inhibitor Aliskiren in Healthy Volunteers Drug Metab. Dispos., August 1, 2007; 35(8): 1418 - 1428. [Abstract] [Full Text] [PDF]

				S. Vaidyanathan, C. Reynolds, C.-M. Yeh, M.-N. Bizot, H. A. Dieterich, D. Howard, and W. P. Dole Pharmacokinetics, Safety, and Tolerability of the Novel Oral Direct Renin Inhibitor Aliskiren in Elderly Healthy Subjects J. Clin. Pharmacol., April 1, 2007; 47(4): 453 - 460. [Abstract] [Full Text] [PDF]