No 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 (n¼40, aged 20-80 years) with mean sitting diastolic blood pressure (msDBP) X95 and o110 mm Hg and serum creatinine between X1.3 and o3.0 mg per 100 ml in males or between X1.2 and o3.0 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 X90 or mean sitting systolic blood pressure [msSBP] X140 mm Hg) and without safety concerns (serum potassium 45.5 mEq l -1 or an increase in serum creatinine X20%), 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 o90 or a 10 mm Hg decrease or msSBP o140 or a 20 mm Hg decrease) and 30% had achieved blood pressure control (msSBP o140 mm Hg and msDBP o90 mm Hg). Aliskiren was well tolerated with no new safety concerns in Japanese hypertensive patients with renal dysfunction.

Introduction:The substantial pandemic