Efficacy and safety of aliskiren in Japanese hypertensive patients with renal
dysfunction.
Author(s): Ito S, Nakura N, Le Breton S, Keefe D.
Affiliation(s): Division of Nephrology, Endocrinology and Vascular Medicine, Department of
Clinical Medicine, Tohoku University Graduate School of Medicine, Aoba-ku,
Sendai, Japan. db554@mail.tains.tohoku.ac.jp
Publication date & source: 2010, Hypertens Res. , 33(1):62-6
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.
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