Efficacy and safety of sacubitril/allisartan for the treatment of primary hypertension: a phase 2 randomized, double-blind study.
Hypertens Res
; 46(8): 2024-2032, 2023 08.
Article
em En
| MEDLINE
| ID: mdl-37258625
ABSTRACT
This randomized, double-blind phase 2 study assessed the efficacy and safety of sacubitril/allisartan, an angiotensin receptor neprilysin inhibitor, compared with placebo in Chinese patients with mild to moderate hypertension. Eligible patients aged 18-75 years (n = 235) with mild to moderate hypertension were randomized to receive sacubitril/allisartan 120 mg (n = 52), sacubitril/allisartan 240 mg (n = 52), sacubitril/allisartan 480 mg (n = 52), placebo (n = 26) or olmesartan 20 mg (n = 53) once daily for 8 weeks. The primary end point was a reduction in clinic systolic blood pressure from baseline with different doses of sacubitril/allisartan versus placebo at 8 weeks. Secondary efficacy variables included clinic diastolic blood pressure and 24-h ambulatory blood pressure for the comparison between sacubitril/allisartan and placebo at 8 weeks. Safety assessments included all adverse events and serious adverse events. Sacubitril/allisartan 480 mg/day provided a significantly greater reduction in clinic systolic blood pressure than placebo at 8 weeks (between-treatment difference -9.1 mmHg [95% confidence interval -1.6 to -16.6 mmHg], P = 0.02). There were also significant reductions in 24-h, daytime and nighttime systolic and diastolic blood pressure for sacubitril/allisartan 480 mg/day compared with placebo (P ≤ 0.03). Similarly, a greater reduction in daytime systolic blood pressure was observed for sacubitril/allisartan 240 mg/day compared with placebo (between-treatment difference -7.3 mmHg [95% confidence interval -0.5 to -14.0 mmHg], P = 0.04). Sacubitril/allisartan was well tolerated, and no cases of angioedema were reported. Sacubitril/allisartan is effective for the treatment of hypertension in Chinese patients and is well tolerated.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Hipertensão Essencial
/
Anti-Hipertensivos
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Aged
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Humans
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Middle aged
Idioma:
En
Revista:
Hypertens Res
Ano de publicação:
2023
Tipo de documento:
Article