Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction

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.