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 (n=40, aged 20-80 years) with mean sitting diastolic blood pressure (msDBP) >= 95 and <110mmHg and serum creatinine between >= 1.3 and <3.0mg 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 75mg of aliskiren. In patients with inadequate blood pressure control (msDBP >= 90 or mean sitting systolic blood pressure [msSBP] >= 140mmHg) and without safety concerns (serum potassium >5.5mEq 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 13.9 +/- 16.6 and 11.6 +/- 9.7mmHg for msSBP and msDBP, respectively. At the Week 8 endpoint, 65% patients had achieved blood pressure response (msDBP <90 or a 10mmHg decrease or msSBP <140 or a 20mmHg decrease) and 30% had achieved blood pressure control (msSBP <140mmHg and msDBP <90mmHg). Aliskiren was well tolerated with no new safety concerns in Japanese hypertensive patients with renal dysfunction. Hypertension Research (2010) 33, 62-66; doi: 10.1038/hr.2009.175; published online 20 November 2009