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Pharmacokinetics, Safety, and Tolerability of the Novel Oral Direct Renin Inhibitor Aliskiren in Elderly Healthy Subjects
Author(s) -
Vaidyanathan Sujata,
Reynolds Christine,
Yeh ChingMing,
Bizot MarieNoëlle,
Dieterich Hans Armin,
Howard Dan,
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 - 10.1177/0091270006297921
Subject(s) - aliskiren , medicine , pharmacokinetics , tolerability , confidence interval , renin inhibitor , blood pressure , pharmacology , renin–angiotensin system , urology , adverse effect
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, AUC 0‐∞ 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 ≤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.