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PI‐21
Author(s) -
Vaidyanathan S.,
Zhao C.,
Yeh C.,
Dieterich H.
Publication year - 2006
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2005.12.042
Subject(s) - aliskiren , medicine , renin inhibitor , type 2 diabetes , pharmacology , diabetes mellitus , renin–angiotensin system , endocrinology , blood pressure
BACKGROUND Aliskiren is the first in a new class of orally effective renin inhibitors for the treatment of hypertension. This study compared the pharmacokinetics and safety of aliskiren in healthy volunteers (HV) and in patients with type 2 diabetes (DM). METHODS In this open‐label, non‐randomized, single center, parallel group, single dose study, a total of 60 subjects (30 HV, 30 DM), received a single 300 mg oral dose of aliskiren. Plasma samples were collected at regular intervals for 96h after dosing for assessment of aliskiren concentrations. AUC and C max are presented as mean±SD; t 1/2 and t max are shown as median values. RESULTS Following the administration of a single oral dose of aliskiren 300 mg, AUC and C max of aliskiren were slightly higher in patients with type 2 diabetes compared with healthy volunteers, but the differences were not clinically meaningful (AUC 0–96h : HV, 1642±1031; DM, 1859±1106 ng·h/mL[ratio of geometric means for DM vs HV, 1.15; 90% CI, 0.89–1.49]; C max : HV, 348±236; DM, 394±288 ng/mL[mean ratio, 1.14; 90% CI, 0.85–1.51]). There were no notable differences between groups in t ½ (HV 39.0, DM 40.7h) or t max (HV 1.25, DM 1.00h). Aliskiren was well tolerated by both groups in this study. CONCLUSIONS Aliskiren shows comparable pharmacokinetics and is well tolerated in healthy volunteers and patients with type 2 diabetes. Clinical Pharmacology & Therapeutics (2005) 79 , P12–P12; doi: 10.1016/j.clpt.2005.12.042