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Pharmacokinetics, safety, and tolerability of the novel oral direct renin inhibitor aliskiren in elderly healthy subjects.
J Clin Pharmacol. 2007 Apr; 47(4):453-60.JC

Abstract

This open-label, multicenter study compared the pharmacokinetics and safety of the oral direct renin inhibitor aliskiren in 29 elderly (>or=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, AUC(0-infinity) was 57% higher (ratio of geometric means 1.57, 90% confidence interval: 1.19, 2.06; P = .008) and C(max) was 28% higher (1.28, 90% confidence interval: 0.91, 1.79; P=.233). Other parameters, including t(max) 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 >or=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.

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Authors+Show Affiliations

Vaidyanathan S
Novartis Fharmaceuticals Corporation, East Hanover, New Jersey, USA.
Reynolds C
No affiliation info available
Yeh CM
No affiliation info available
Bizot MN
No affiliation info available
Dieterich HA
No affiliation info available
Howard D
No affiliation info available
Dole WP
No affiliation info available

MeSH

AdolescentAdultAge FactorsAgedAged, 80 and overAmidesArea Under CurveFemaleFumaratesGlomerular Filtration RateHalf-LifeHumansMaleMetabolic Clearance RateMiddle AgedRenin

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17389554

Citation

Vaidyanathan, Sujata, et al. "Pharmacokinetics, Safety, and Tolerability of the Novel Oral Direct Renin Inhibitor Aliskiren in Elderly Healthy Subjects." Journal of Clinical Pharmacology, vol. 47, no. 4, 2007, pp. 453-60.
Vaidyanathan S, Reynolds C, Yeh CM, et al. Pharmacokinetics, safety, and tolerability of the novel oral direct renin inhibitor aliskiren in elderly healthy subjects. J Clin Pharmacol. 2007;47(4):453-60.
Vaidyanathan, S., Reynolds, C., Yeh, C. M., Bizot, M. N., Dieterich, H. A., Howard, D., & Dole, W. P. (2007). Pharmacokinetics, safety, and tolerability of the novel oral direct renin inhibitor aliskiren in elderly healthy subjects. Journal of Clinical Pharmacology, 47(4), 453-60.
Vaidyanathan S, et al. Pharmacokinetics, Safety, and Tolerability of the Novel Oral Direct Renin Inhibitor Aliskiren in Elderly Healthy Subjects. J Clin Pharmacol. 2007;47(4):453-60. PubMed PMID: 17389554.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetics, safety, and tolerability of the novel oral direct renin inhibitor aliskiren in elderly healthy subjects. AU - Vaidyanathan,Sujata, AU - Reynolds,Christine, AU - Yeh,Ching-Ming, AU - Bizot,Marie-Noëlle, AU - Dieterich,Hans Armin, AU - Howard,Dan, AU - Dole,William P, PY - 2007/3/29/pubmed PY - 2007/6/6/medline PY - 2007/3/29/entrez SP - 453 EP - 60 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 47 IS - 4 N2 - This open-label, multicenter study compared the pharmacokinetics and safety of the oral direct renin inhibitor aliskiren in 29 elderly (>or=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, AUC(0-infinity) was 57% higher (ratio of geometric means 1.57, 90% confidence interval: 1.19, 2.06; P = .008) and C(max) was 28% higher (1.28, 90% confidence interval: 0.91, 1.79; P=.233). Other parameters, including t(max) 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 >or=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. SN - 0091-2700 UR - https://www.unboundmedicine.com/medline/citation/17389554/Pharmacokinetics_safety_and_tolerability_of_the_novel_oral_direct_renin_inhibitor_aliskiren_in_elderly_healthy_subjects_ L2 - https://doi.org/10.1177/0091270006297921 DB - PRIME DP - Unbound Medicine ER -