Premium
Pharmacokinetics, Safety, and Tolerability of the Oral Renin Inhibitor Aliskiren in Patients With Hepatic Impairment
Author(s) -
Vaidyanathan Sujata,
Warren Vance,
Yeh ChingMing,
Bizot MarieNoelle,
Dieterich Hans Armin,
Dole William P.
Publication year - 2007
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270006294404
Subject(s) - aliskiren , pharmacokinetics , cmax , medicine , tolerability , confidence interval , gastroenterology , oral administration , pharmacology , adverse effect , renin–angiotensin system , blood pressure
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.