Efficacy and safety of sacubitril/allisartan for the treatment of primary hypertension: a phase 2 randomized, double-blind study.
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| 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.
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| Authors | Jin Zhang, Wei Zhang, Jie Yan, Qian Ge, Xiao-Hong Lu, Shao-Xing Chen, Wen-Jie Xu, Ying Li, Jin-Feng Li, Shi-Ying He, Ji-Guang Wang |
| Journal | Hypertension research : official journal of the Japanese Society of Hypertension (Hypertens Res) Vol. 46 Issue 8 Pg. 2024-2032 (08 2023) ISSN: 1348-4214 [Electronic] England |
| PMID | 37258625 (Publication Type: Randomized Controlled Trial, Clinical Trial, Phase II, Journal Article) |
| Copyright | © 2023. The Author(s), under exclusive licence to The Japanese Society of Hypertension. |
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