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Pharmacokinetics, safety, and tolerability of the oral Renin inhibitor aliskiren in patients with hepatic impairment.

Vaidyanathan, Sujata and Warren, Vance and Yeh, Chingming and Bizot, Marie-Noelle and Dieterich, Hans Armin and Dole, William P (2007) Pharmacokinetics, safety, and tolerability of the oral Renin inhibitor aliskiren in patients with hepatic impairment. Journal of Clinical Pharmacology, 47 (2). pp. 192-200. ISSN 0091-2700

Abstract

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-infinity) (ratio of geometric means, 1.12; 90% confidence interval, 0.85, 1.48) or Cmax (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-infinity) or Cmax. 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.

Item Type: Article
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Keywords: Aliskiren; liver; pharmacokinetics; reninangiotensin system
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Date Deposited: 14 Dec 2009 14:07
Last Modified: 31 Jan 2013 01:32
URI: https://oak.novartis.com/id/eprint/14

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