Document Detail

Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction.
MedLine Citation:
PMID:  19927154     Owner:  NLM     Status:  MEDLINE    
This 12-week, multicenter, open-label study assessed the efficacy, pharmacokinetics and safety of a once-daily aliskiren in Japanese hypertensive patients with renal dysfunction. Patients (n=40, aged 20-80 years) with mean sitting diastolic blood pressure (msDBP) >or=95 and <110 mm Hg and serum creatinine between >or=1.3 and <3.0 mg per 100 ml in males or between >or=1.2 and <3.0 mg per 100 ml in females were eligible. Patients began therapy with a once-daily morning oral dose of 75 mg of aliskiren. In patients with inadequate blood pressure control (msDBP >or=90 or mean sitting systolic blood pressure [msSBP] >or=140 mm Hg) and without safety concerns (serum potassium >5.5 mEq l(-1) or an increase in serum creatinine >or=20%), the aliskiren dose was increased to 150 mg and then to 300 mg in sequential steps starting from Week 2. Efficacy was assessed as change in msSBP/msDBP from baseline to the Week 8 endpoint (with the last observation carried forward). The mean reduction from baseline to Week 8 endpoint was 13.9+/-16.6 and 11.6+/-9.7 mm Hg for msSBP and msDBP, respectively. At the Week 8 endpoint, 65% patients had achieved blood pressure response (msDBP <90 or a 10 mm Hg decrease or msSBP <140 or a 20 mm Hg decrease) and 30% had achieved blood pressure control (msSBP <140 mm Hg and msDBP <90 mm Hg). Aliskiren was well tolerated with no new safety concerns in Japanese hypertensive patients with renal dysfunction.
Sadayoshi Ito; Noriko Nakura; Stephanie Le Breton; Deborah Keefe
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-11-20
Journal Detail:
Title:  Hypertension research : official journal of the Japanese Society of Hypertension     Volume:  33     ISSN:  1348-4214     ISO Abbreviation:  Hypertens. Res.     Publication Date:  2010 Jan 
Date Detail:
Created Date:  2010-01-05     Completed Date:  2010-03-01     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9307690     Medline TA:  Hypertens Res     Country:  England    
Other Details:
Languages:  eng     Pagination:  62-6     Citation Subset:  IM    
Division of Nephrology, Endocrinology and Vascular Medicine, Department of Clinical Medicine, Tohoku University Graduate School of Medicine, Aoba-ku, Sendai, Japan.
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MeSH Terms
Aged, 80 and over
Amides / adverse effects,  pharmacokinetics,  therapeutic use*
Antihypertensive Agents / adverse effects,  pharmacokinetics,  therapeutic use*
Blood Chemical Analysis
Dose-Response Relationship, Drug
Double-Blind Method
Fumarates / adverse effects,  pharmacokinetics,  therapeutic use*
Hypertension / complications*,  drug therapy*,  physiopathology
Kidney Diseases / complications*
Middle Aged
Renin / antagonists & inhibitors
Renin-Angiotensin System / drug effects
Risk Assessment
Young Adult
Reg. No./Substance:
0/Amides; 0/Antihypertensive Agents; 0/Fumarates; 0/aliskiren; EC

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