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.