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Clinical and research medicine: Cardiovascular clinical pharmaceutical research
e0352 Efficacy and safety of aliskiren in chinese patients with mild or moderate essential hypertension
  1. Sun Ningling1,
  2. Zhu Junren2
  1. 1People's Hospital Peking University
  2. 2Zhongshan Hospital Shanghai

Abstract

To assess the antihypertensive efficacy and safety of aliskiren compared with ramipril in Chinese patients with mild or moderate essential hypertension.

Methods This is a double-blind randomised, multicenter, parallel group, active-controlled study. Following washout and single-blind placebo run-in period, 1147 patients with essential hypertension (mean sitting diastolic blood pressure [msDBP] ≥95 and 110 mm Hg) were randomised to receive either aliskiren 300 mg (n=288), 150 mg (n=284), 75mg (n=289) or ramipril 5 mg (n=286) for 8 weeks. Efficacy and safety were assessed at Week 2, 4 and 8 in treatment duration.

Results 994 (86.7%) completed the study. At week 8, aliskiren therapy produced greater mean blood pressure reductions compared with ramipril therapy. All aliskiren dose groups were statistically non-inferior (p<0.0001) to ramipril group in reducing msDBP. Aliskiren 300 mg group also showed statistically significantly superior reductions in msDBP and msSBP compared to ramipril 5 mg group (p=0.0002 and p=0.0073, respectively). Blood pressure control rates (target blood pressure 90 mm Hg) were higher for aliskiren groups (300 mg, 52.46%; 150 mg, 49.82% and 75 mg, 45.91%) compared to ramipril (5 mg, 44.44%); and aliskiren 300 mg group was significantly superior to ramipri l5 mg group (p=0.0359). The overall incidence of adverse effects (AEs) was similar among the treatment groups. The ramipril group had at least a four times higher incidence of cough (6.0%) compared with the three aliskiren treatments (ranging from 0.4% to 1.4%).

Conclusion Aliskiren was well tolerated, and superior or non-inferior to ramipril in lowering BP in Chinese patients with essential hypertension.

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