TY - JOUR
T1 - Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction
AU - Ito, Sadayoshi
AU - Nakura, Noriko
AU - Le Breton, Stephanie
AU - Keefe, Deborah
N1 - Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2010/1
Y1 - 2010/1
N2 - 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 (n40, aged 20-80 years) with mean sitting diastolic blood pressure (msDBP)≥95 and <110 mm Hg and serum creatinine between ≥1.3 and <3.0 mg per 100 ml in males or between ≥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 ≥90 or mean sitting systolic blood pressure msSBP ≥140 mm Hg) and without safety concerns (serum potassium <5.5 mEq l-1 or an increase in serum creatinine ≥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 13.916.6 and 11.69.7 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.
AB - 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 (n40, aged 20-80 years) with mean sitting diastolic blood pressure (msDBP)≥95 and <110 mm Hg and serum creatinine between ≥1.3 and <3.0 mg per 100 ml in males or between ≥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 ≥90 or mean sitting systolic blood pressure msSBP ≥140 mm Hg) and without safety concerns (serum potassium <5.5 mEq l-1 or an increase in serum creatinine ≥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 13.916.6 and 11.69.7 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.
KW - Aliskiren
KW - Direct renin inhibitor
KW - Renal dysfunction
KW - Renin-angiotensin- aldosterone system
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U2 - 10.1038/hr.2009.175
DO - 10.1038/hr.2009.175
M3 - Article
C2 - 19927154
AN - SCOPUS:74349119971
VL - 33
SP - 62
EP - 66
JO - Hypertension Research
JF - Hypertension Research
SN - 0916-9636
IS - 1
ER -