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Efficacy and safety of sacubitril/valsartan in patients with essential hypertension uncontrolled by olmesartan: A randomized,double‐blind, 8‐week study
Authors:Deanna G. Cheung MD  Diego Aizenberg MD  Vladimir Gorbunov MD  Kudsia Hafeez PhD  Chien‐Wei Chen PhD  Jack Zhang MD
Affiliation:1. Long Beach Center for Clinical Research, Long Beach, CA, USA;2. Centro Medico Viamonte, Buenos Aires, Argentina;3. National Medical Research Center for Preventive Medicine, Moscow, Russia;4. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA;5. Alcon Laboratories, Inc., Fort Worth, TX, USA
Abstract: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.
Keywords:blood pressure  efficacy  hypertension  olmesartan  sacubitril/valsartan  safety
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