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Pharmacokinetics, safety, and tolerability of the oral Renin inhibitor aliskiren in patients with hepatic impairment.
J Clin Pharmacol. 2007 Feb; 47(2):192-200.JC

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.

Authors+Show Affiliations

Novartis Institute for Biomedical Research, 400 Technology Square, Building 605-820, Cambridge, MA 02139, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Controlled Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17244770

Citation

Vaidyanathan, Sujata, et al. "Pharmacokinetics, Safety, and Tolerability of the Oral Renin Inhibitor Aliskiren in Patients With Hepatic Impairment." Journal of Clinical Pharmacology, vol. 47, no. 2, 2007, pp. 192-200.
Vaidyanathan S, Warren V, Yeh C, et al. Pharmacokinetics, safety, and tolerability of the oral Renin inhibitor aliskiren in patients with hepatic impairment. J Clin Pharmacol. 2007;47(2):192-200.
Vaidyanathan, S., Warren, V., Yeh, C., Bizot, M. N., Dieterich, H. A., & Dole, W. P. (2007). Pharmacokinetics, safety, and tolerability of the oral Renin inhibitor aliskiren in patients with hepatic impairment. Journal of Clinical Pharmacology, 47(2), 192-200.
Vaidyanathan S, et al. Pharmacokinetics, Safety, and Tolerability of the Oral Renin Inhibitor Aliskiren in Patients With Hepatic Impairment. J Clin Pharmacol. 2007;47(2):192-200. PubMed PMID: 17244770.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetics, safety, and tolerability of the oral Renin inhibitor aliskiren in patients with hepatic impairment. AU - Vaidyanathan,Sujata, AU - Warren,Vance, AU - Yeh,Chingming, AU - Bizot,Marie-Noelle, AU - Dieterich,Hans Armin, AU - Dole,William P, PY - 2007/1/25/pubmed PY - 2007/4/14/medline PY - 2007/1/25/entrez SP - 192 EP - 200 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 47 IS - 2 N2 - 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. SN - 0091-2700 UR - https://www.unboundmedicine.com/medline/citation/17244770/Pharmacokinetics_safety_and_tolerability_of_the_oral_Renin_inhibitor_aliskiren_in_patients_with_hepatic_impairment_ L2 - https://doi.org/10.1177/0091270006294404 DB - PRIME DP - Unbound Medicine ER -