title: Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction.
abstract: 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.
authors.affiliation: 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
authors.forename: Sadayoshi
authors.initials: S
authors.lastname: Ito
authors.forename: Noriko
authors.initials: N
authors.lastname: Nakura
authors.forename: Stephanie
authors.initials: S
authors.lastname: Le Breton
authors.forename: Deborah
authors.initials: D
authors.lastname: Keefe
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000577:Amides / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001774:Blood Chemical Analysis; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005650:Fumarates / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000188:drug therapy* / Q000503:physiopathology; D007564:Japan; D007674:Kidney Diseases / Q000150:complications*; D008297:Male; D008875:Middle Aged; D012084:Renin-Angiotensin System / Q000187:drug effects; D018570:Risk Assessment; D055815:Young Adult; D000092502:Renin Inhibitors
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D005650:Fumarates; D000092502:Renin Inhibitors; C446481:aliskiren