Efficacy and safety of sacubitril/valsartan in patients with essential hypertension uncontrolled by olmesartan: A randomized, double-blind, 8-week study.

A majority of patients with hypertension fail to achieve blood pressure (BP) control despite treatment with commonly prescribed drugs. This randomized, double-blind phase III trial assessed the superiority of sacubitril/valsartan 200 mg (97/103 mg) to continued olmesartan 20 mg in reducing ambulatory systolic BP after 8-week treatment in patients with mild to moderate essential hypertension uncontrolled with olmesartan 20 mg alone. A total of 376 patients were randomized to receive either sacubitril/valsartan (n = 188) or olmesartan (n = 188). Superior reductions in 24-hour mean ambulatory systolic BP were observed in the sacubitril/valsartan group vs the olmesartan group (-4.3 mm Hg vs -1.1 mm Hg, P < .001). Reductions in 24-hour mean ambulatory diastolic BP and pulse pressure and office systolic BP and diastolic BP were significantly greater with sacubitril/valsartan vs olmesartan (P < .014). A greater proportion of patients achieved BP control with sacubitril/valsartan vs olmesartan. The overall incidence of adverse events was comparable between the groups. Compared with continued olmesartan, sacubitril/valsartan was more effective and generally safe in patients with hypertension uncontrolled with olmesartan 20 mg.

Effectiveness of Fixed-Dose Perindopril/Amlodipine on Clinic, Ambulatory and Self-Monitored Blood Pressure and Blood Pressure Variability: An Open-Label, Non Comparative Study in the General Practice.

INTRODUCTION: Fixed-dose combinations (FDCs) of antihypertensive agents improve therapeutic efficacy, according to current guidelines and large clinical studies. AIM: This Russian study examined the effect on blood pressure (BP) of substituting current ineffective antihypertensive treatment with FDC perindopril/amlodipine in patients with uncontrolled hypertension. METHODS: BP was measured in the doctor's office at each visit, daily at home, and by ambulatory monitoring (ABPM) at inclusion and end-of-study. RESULTS: Ninety patients (52.7 ± 12.2 years old; mean baseline BP 161.4/94.9 mmHg) at high or very high cardiovascular risk were included. FDC perindopril/amlodipine (5/5, 10/5 or 10/10 mg) exerted a rapid (2 weeks) and significant (p < 0.001) reduction in clinic BP, maintained after 3 months (-33.7/17.1 mmHg). ABPM and home monitoring showed that BP decrease remained significant throughout the study (p < 0.0001). BP variability was reduced, indicating the stable and homogeneous 24-h antihypertensive effect of FDC perindopril/amlodipine. Quality of life and adherence were also improved. CONCLUSIONS: The three main methods of BP assessment showed that substituting ineffective antihypertensive therapy with FDC perindopril/amlodipine resulted in a rapid and pronounced antihypertensive effect, with target BP levels achieved after 3 months in most patients. This beneficial effect was observed also on various parameters related to BP variability, which may reflect additional cardioprotective properties.