J Clin Pharmacol
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Sign In to gain access to subscriptions and/or personal tools.
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Request Reprints
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via ISI Web of Science (9)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Vaidyanathan, S.
Right arrow Articles by Dole, W. P.
Right arrow Search for Related Content
PubMed
Right arrow Articles by Vaidyanathan, S.
Right arrow Articles by Dole, W. P.

PHARMACOKINETICS

Pharmacokinetics, Safety, and Tolerability of the Novel Oral Direct Renin Inhibitor Aliskiren in Elderly Healthy Subjects

Sujata Vaidyanathan, PhD, Christine Reynolds, BS, Ching-Ming Yeh, PhD, Marie-Noëlle Bizot, PhD, Hans Armin Dieterich, MD, PhD, Dan Howard, PhD and William P. Dole, MD

From Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (Dr Vaidyanathan, Ms Reynolds, Dr Yeh, Dr Howard); 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). None of the authors are fellows of the American College of Clinical Pharmacology (FCP).

This open-label, multicenter study compared the pharmacokinetics and safety of the oral direct renin inhibitor aliskiren in 29 elderly (≥65 years) and 28 young (18-45 years) healthy subjects. Plasma drug concentrations were determined for up to 168 hours following a single 300-mg oral dose of aliskiren. In elderly compared with young subjects, AUC0-{infty} was 57% higher (ratio of geometric means 1.57, 90% confidence interval: 1.19, 2.06; P = .008) and Cmax was 28% higher (1.28, 90% confidence interval: 0.91, 1.79; P = .233). Other parameters, including tmax and Vd/F, were similar between age groups. No differences in aliskiren exposure were observed between subjects ages 65 to 74 years (n = 16) and ≥75 years (n = 13). Aliskiren was well tolerated by all age groups, including the very elderly. In conclusion, aliskiren exposure is modestly increased in elderly subjects. Based on its wide therapeutic index and shallow dose response for blood pressure lowering, no initial dose adjustment should be needed for elderly patients.

Key Words: Aliskiren • renin inhibitor • pharmacokinetics • elderly

Address for reprints: William P. Dole, MD, Novartis Institutes for Biomedical Research, 400 Technology Square, Building 605-820, Cambridge, MA 02139; e-mail: bill.dole{at}novartis.com.




This article has been cited by other articles:


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

Home page
 J Clin PharmacolHome page
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]

Home page
 HypertensionHome page
D. J. Campbell
Interpretation of Plasma Renin Concentration in Patients Receiving Aliskiren Therapy
Hypertension, January 1, 2008; 51(1): 15 - 18.
[Full Text] [PDF]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 2007 by the American College of Clinical Pharmacology