Abstract
This phase III study assessed the efficacy and safety of sacubitril/valsartan compared with those of olmesartan in Japanese patients with essential hypertension. Patients (n = 1161, aged ≥20 years) with mild to moderate hypertension (mean sitting systolic blood pressure [msSBP] ≥150 to <180 mmHg) were randomized to receive sacubitril/valsartan 200 mg (n = 387), sacubitril/valsartan 400 mg (n = 385), or olmesartan 20 mg (n = 389) once daily for 8 weeks. The primary assessment was a reduction in msSBP from baseline with sacubitril/valsartan 200 mg vs. olmesartan 20 mg at Week 8. Secondary assessments included msSBP reduction with sacubitril/valsartan 400 mg vs. olmesartan at Week 8 and reductions in mean sitting diastolic blood pressure (msDBP), mean sitting pulse pressure (msPP), and overall blood pressure (BP) control rate for all treatment groups at Week 8. Sacubitril/valsartan 200 mg provided a significantly greater reduction in msSBP from baseline than olmesartan at Week 8 (between-treatment difference: −5.01 mmHg [95% confidence interval: −6.95 to −3.06 mmHg, P < 0.001 for noninferiority and superiority]). Greater reductions in msSBP with sacubitril/valsartan 400 mg vs. olmesartan, as well as in msDBP and msPP with both doses of sacubitril/valsartan vs. olmesartan (P < 0.05 for all), were also observed. Patients treated with sacubitril/valsartan achieved an overall higher BP control rate. The safety and tolerability profiles of sacubitril/valsartan were generally comparable to those of olmesartan. The adverse event rate with sacubitril/valsartan was not dose-dependent. Treatment with sacubitril/valsartan was effective and provided superior BP reduction, with a higher proportion of patients achieving target BP goals than treatment with olmesartan in Japanese patients with mild to moderate essential hypertension.
Highlights
This study was presented at the AHA 2013 and AHA 2014 and at HBPR 2013 and HBPR 2014
Treated patients, defined as patients having a history of hypertension receiving antihypertensive medications within 4 weeks prior to screening, with mean sitting systolic blood pressure ranging from ≥150 to
Total discontinuation and discontinuation due to adverse events (AEs) or a lack of efficacy were more frequent in the olmesartan group than in the sacubitril/valsartan group
Summary
The primary objective of this study was to compare the efficacy of sacubitril/valsartan 200 mg with that of olmesartan 20 mg by evaluating (i) the hypothesis of the noninferiority of sacubitril/valsartan 200 mg vs olmesartan 20 mg for a decrease in msSBP from baseline and (ii) if the hypothesis of noninferiority was met, the hypothesis of the superiority of sacubitril/valsartan 200 mg over olmesartan 20 mg for a decrease in msSBP from baseline was tested
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