Article

Aliskiren, a Novel Oral Renin Inhibitor, Provides Dose-Dependent Efficacy and Placebo-Like Tolerability in Japanese Patients with Hypertension

Department of Cardiology, Nihon University Surugadai Hospital, Tokyo, Japan.
Hypertension Research (Impact Factor: 2.66). 01/2007; 29(12):997-1005. DOI: 10.1291/hypres.29.997
Source: PubMed

ABSTRACT

Aliskiren is a novel orally active renin inhibitor for the treatment of hypertension. This study evaluated the antihypertensive efficacy, safety and tolerability of aliskiren in Japanese patients with hypertension. Forty hundred and fifty-five Japanese men and women with a mean sitting diastolic blood pressure of 95-110 mmHg were randomized to receive once-daily double-blind treatment for 8 weeks with aliskiren 75, 150 or 300 mg or placebo. Aliskiren produced significant, dose-dependent reductions in mean sitting diastolic blood pressure (p<0.0005 vs. placebo for each dose) and mean sitting systolic blood pressure (p<0.001 vs. placebo for each dose). The placebo-corrected reductions in mean sitting systolic/diastolic blood pressure were 5.7/4.0, 5.9/4.5 and 11.2/7.5 mmHg in the aliskiren 75, 150 and 300 mg groups, respectively. After 8 weeks' treatment, 27.8%, 47.8%, 48.2% and 63.7% of patients in the placebo and aliskiren 75, 150 and 300 mg groups, respectively, achieved a successful treatment response (diastolic blood pressure <90 mmHg and/or reduced by > or =10 mmHg from baseline; p<0.005 vs. placebo for each dose). Aliskiren treatment was well tolerated, with the incidence of adverse events reported in the active treatment groups (53-55%) being similar to that in the placebo group (50%). This study, which is the first to assess the antihypertensive efficacy and safety of aliskiren in Japanese patients with hypertension, demonstrates that the once-daily oral renin inhibitor aliskiren provides significant, dose-dependent reductions in blood pressure with placebo-like tolerability.

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    • "In a placebo-controlled study of 455 Japanese patients with hypertension and a mean sitting diastolic blood pressure of 95–110 mmHg, aliskiren in doses of 75, 150, and 300 mg lowered blood pressure in a dose-dependent manner. Interestingly, after correcting for placebo, the reduction in systolic and diastolic blood pressure was 5.7/4 mmHg, 5.9/4.5 mmHg, and 11.2/7.5 mmHg, respectively, indicating a rather small effect.37 "
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