Efficacy and safety of sacubitril valsartan in the treatment of hypertension: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 GUO Jiao ¹ , LIU Luyao ² , LIU Xincan ¹

1. Department of Cardiology, the First Affiliated Hospital of Henan University of TCM, Zhengzhou 450008, P. R. China;
2. Henan University of Traditional Chinese Medicine, Zhengzhou 450000, P. R. China;

Corresponding author：

GUO Jiao, Email: guozi061100328@163.com

Keywords：

Sacubitril valsartan; Entresto; Hypertension; Meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.202301084

Video：

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Objective To systematically review the efficacy and safety of sacubitri valsartan in the treatment of hypertension. Methods PubMed, ClinicalTrials.gov, CNKI, WanFang Data and CBM databases were electronically searched to collect randomized controlled trials (RCTs) of sacubitril valsartan in the treatment of hypertension from inception to August 31, 2022. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.3 and Stata 13.0 software. Results A total of 11 RCTs involving 3 564 patients were included. Meta-analysis showed that compared with control group, sitting systolic blood pressure (MD=−6.85, 95%CI −9.94 to −3.76, P<0.01) and sitting diastolic blood pressure (MD=−3.70, 95%CI −5.61 to −1.79, P<0.01) significantly decreased in the experimental group, and the difference was statistically significant. The results of subgroup analysis did not show significant changes. At the same time, the incidence of adverse reactions with sacubitril valsartan was low, and no fatal adverse events were observed. Conclusion Current evidence shows that sacubitril valsartan in the treatment of hypertension has definite efficacy and fewer adverse reactions. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.

Citation： GUO Jiao, LIU Luyao, LIU Xincan. Efficacy and safety of sacubitril valsartan in the treatment of hypertension: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2023, 23(6): 679-683. doi: 10.7507/1672-2531.202301084 Copy

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2.	王增武, 杨瑛, 王文, 等. 我国高血压流行新特征—中国高血压调查的亮点和启示. 中国循环杂志, 2018, 33(10): 937-939.
3.	中国高血压防治指南修订委员会, 高血压联盟(中国), 中华医学会心血管病学分会中国医师协会高血压专业委员会, 等. 中国高血压防治指南(2018年修订版). 中国心血管杂志, 2019, 24(1): 24-56.
4.	中国医疗保健国际交流促进会高血压分会, 中国医师协会心血管分会, 中国高血压联盟, 等. 沙库巴曲缬沙坦在高血压患者临床应用的中国专家建议. 中华高血压杂志, 2021, 29(2): 108-114.
5.	中华医学会, 中华医学会杂志社, 中华医学会全科医学分会, 等. 高血压基层诊疗指南(实践版·2019). 中华全科医师杂志, 2019, 18(8): 723-731.
6.	Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5.1. 0. 2011.
7.	Zeng X, Zhang Y, Kwong JS, et al. The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review. J Evid Based Med, 2015, 8(1): 2-10.
8.	曾宪涛, 包翠萍, 曹世义, 等. Meta分析系列之三: 随机对照试验的质量评价工具. 中国循证心血管医学杂志, 2012, 4(3): 183-185.
9.	曾宪涛, 熊期, 沈可. Meta分析系列之十三: 盲法的评价. 中国循证心血管医学杂志, 2013, 5(4): 331-333.
10.	曾宪涛, 黄伟, 沈可. Meta分析系列之十一: 随机化的评价. 中国循证心血管医学杂志, 2013, 5(2): 101-103.
11.	曾宪涛, 沈可, 罗杰. Meta分析系列之十二: 分配隐藏的评价. 中国循证心血管医学杂志, 2013, 5(3): 219-221.
12.	曾宪涛, Joey SWK, 田国祥, 等. Meta分析系列之二: Meta分析的软件. 中国循证心血管医学杂志, 2012, 4(2): 89-91.
13.	Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med, 2002, 21(11): 1539-1558.
14.	杨娟, 郑青山. Meta分析的统计学方法. 中国临床药理学与治疗学, 2005, 10(11): 1309-1314.
15.	康德英, 洪旗, 刘关键, 等. Meta分析中发表性偏倚的识别与处理. 中国循证医学杂志, 2003, 3(1): 45-49.
16.	张存新, 陈俊华. 沙库巴曲缬沙坦治疗原发性高血压并射血分数保留心力衰竭的疗效. 武警医学, 2020, 31(12): 1017-1020.
17.	任智超, 何廉旗, 张建, 等. 沙库巴曲缬沙坦治疗盐敏感性高血压的效果分析. 中国当代医药, 2022, 29(4): 79-81.
18.	何爱荣, 薛德刚, 韩笑. 沙库巴曲缬沙坦治疗高血压合并左心室肥厚患者的疗效分析. 中国实用医药, 2022, 17(17): 107-109.
19.	张大喜, 李爱霞, 王鲜. 沙库巴曲缬沙坦治疗高血压合并射血分数保留心力衰竭患者临床观察. 社区医学杂志, 2022, 20(8): 440-444.
20.	时庆平, 兰玲, 尹丽君, 等. 沙库巴曲缬沙坦用于老年高血压心脏病的效果观察. 老年医学与保健, 2021, 27(5): 944-947.
21.	高峰. 老年高血压治疗过程中采用沙库巴曲缬沙坦治疗的效果研究. 中西医结合心血管病电子杂志, 2021, 9(1): 123-125.
22.	Williams B, Cockcroft JR, Kario K, et al. Effects of sacubitril/valsartan versus olmesartan on central hemodynamics in the elderly with systolic hypertension: the PARAMETER study. Hypertension, 2017, 69(3): 411-420.
23.	Supasyndh O, Wang J, Hafeez K, et al. Efficacy and safety of sacubitril/valsartan (lcz696) compared with olmesartan in elderly asian patients (≥65 years) with systolic hypertension. Am J Hypertens, 2017, 30(12): 1163-1169.
24.	Cheung DG, Aizenberg D, Gorbunov V, et al. Efficacy and safety of sacubitril/valsartan in patients with essential hypertension uncontrolled by olmesartan: a randomized, double-blind, 8-week study. J Clin Hypertens (Greenwich), 2018, 20(1): 150-158.
25.	Huo Y, Li W, Webb R, et al. Efficacy and safety of sacubitril/valsartan compared with olmesartan in Asian patients with essential hypertension: a randomized, double-blind, 8-week study. J Clin Hypertens (Greenwich), 2019, 21(1): 67-76.
26.	Schmieder RE, Wagner F, Mayr M, et al. The effect of sacubitril/valsartan compared to olmesartan on cardiovascular remodelling in subjects with essential hypertension: the results of a randomized, double-blind, active-controlled study. Eur Heart J, 2017, 38(44): 3308-3317.
27.	国家卫生健康委员会疾病预防控制局, 国家心血管病中心, 中国医学科学院阜外医院, 等. 中国高血压健康管理规范(2019). 中华心血管病杂志, 2020, 48(1): 10-46.
28.	Zhou M, Wang H, Zeng X, et al. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the global burden of disease study 2017. Lancet, 2019, 394(10204): 1145-1158.
29.	黄文博, 冯娴, 姚元龙, 等. 全科医学视角下我国高血压患者的自我管理. 中华全科医学, 2022, 20(7): 1085-1088.
30.	Ma TK, Kam KK, Yan BP, et al. Renin-angiotensin-aldosterone system blockade for cardiovascular diseases: current status. Br J Pharmacol, 2010, 160(6): 1273-1292.
31.	张薇琳, 周海英, 杨小明. 双效血管紧张素受体-脑啡肽酶抑制剂沙库巴曲/缬沙坦的研究进展. 世界临床药物, 2017, 38(12): 851-854.
32.	赖朝辉, 刘迎午, 王禹, 等. 沙库巴曲缬沙坦钠对射血分数减低的心力衰竭合并高血压患者血压及相关指标变化的研究. 中华老年心脑血管病杂志, 2022, 24(1): 11-13.

1. Wang Z, Chen Z, Zhang L, et al. Status of hypertension in China: results from the china hypertension survey, 2012-2015. Circulation, 2018, 137(22): 2344-2356.
2. 王增武, 杨瑛, 王文, 等. 我国高血压流行新特征—中国高血压调查的亮点和启示. 中国循环杂志, 2018, 33(10): 937-939.
3. 中国高血压防治指南修订委员会, 高血压联盟(中国), 中华医学会心血管病学分会中国医师协会高血压专业委员会, 等. 中国高血压防治指南(2018年修订版). 中国心血管杂志, 2019, 24(1): 24-56.
4. 中国医疗保健国际交流促进会高血压分会, 中国医师协会心血管分会, 中国高血压联盟, 等. 沙库巴曲缬沙坦在高血压患者临床应用的中国专家建议. 中华高血压杂志, 2021, 29(2): 108-114.
5. 中华医学会, 中华医学会杂志社, 中华医学会全科医学分会, 等. 高血压基层诊疗指南(实践版·2019). 中华全科医师杂志, 2019, 18(8): 723-731.
6. Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5.1. 0. 2011.
7. Zeng X, Zhang Y, Kwong JS, et al. The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review. J Evid Based Med, 2015, 8(1): 2-10.
8. 曾宪涛, 包翠萍, 曹世义, 等. Meta分析系列之三: 随机对照试验的质量评价工具. 中国循证心血管医学杂志, 2012, 4(3): 183-185.
9. 曾宪涛, 熊期, 沈可. Meta分析系列之十三: 盲法的评价. 中国循证心血管医学杂志, 2013, 5(4): 331-333.
10. 曾宪涛, 黄伟, 沈可. Meta分析系列之十一: 随机化的评价. 中国循证心血管医学杂志, 2013, 5(2): 101-103.
11. 曾宪涛, 沈可, 罗杰. Meta分析系列之十二: 分配隐藏的评价. 中国循证心血管医学杂志, 2013, 5(3): 219-221.
12. 曾宪涛, Joey SWK, 田国祥, 等. Meta分析系列之二: Meta分析的软件. 中国循证心血管医学杂志, 2012, 4(2): 89-91.
13. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med, 2002, 21(11): 1539-1558.
14. 杨娟, 郑青山. Meta分析的统计学方法. 中国临床药理学与治疗学, 2005, 10(11): 1309-1314.
15. 康德英, 洪旗, 刘关键, 等. Meta分析中发表性偏倚的识别与处理. 中国循证医学杂志, 2003, 3(1): 45-49.
16. 张存新, 陈俊华. 沙库巴曲缬沙坦治疗原发性高血压并射血分数保留心力衰竭的疗效. 武警医学, 2020, 31(12): 1017-1020.
17. 任智超, 何廉旗, 张建, 等. 沙库巴曲缬沙坦治疗盐敏感性高血压的效果分析. 中国当代医药, 2022, 29(4): 79-81.
18. 何爱荣, 薛德刚, 韩笑. 沙库巴曲缬沙坦治疗高血压合并左心室肥厚患者的疗效分析. 中国实用医药, 2022, 17(17): 107-109.
19. 张大喜, 李爱霞, 王鲜. 沙库巴曲缬沙坦治疗高血压合并射血分数保留心力衰竭患者临床观察. 社区医学杂志, 2022, 20(8): 440-444.
20. 时庆平, 兰玲, 尹丽君, 等. 沙库巴曲缬沙坦用于老年高血压心脏病的效果观察. 老年医学与保健, 2021, 27(5): 944-947.
21. 高峰. 老年高血压治疗过程中采用沙库巴曲缬沙坦治疗的效果研究. 中西医结合心血管病电子杂志, 2021, 9(1): 123-125.
22. Williams B, Cockcroft JR, Kario K, et al. Effects of sacubitril/valsartan versus olmesartan on central hemodynamics in the elderly with systolic hypertension: the PARAMETER study. Hypertension, 2017, 69(3): 411-420.
23. Supasyndh O, Wang J, Hafeez K, et al. Efficacy and safety of sacubitril/valsartan (lcz696) compared with olmesartan in elderly asian patients (≥65 years) with systolic hypertension. Am J Hypertens, 2017, 30(12): 1163-1169.
24. Cheung DG, Aizenberg D, Gorbunov V, et al. Efficacy and safety of sacubitril/valsartan in patients with essential hypertension uncontrolled by olmesartan: a randomized, double-blind, 8-week study. J Clin Hypertens (Greenwich), 2018, 20(1): 150-158.
25. Huo Y, Li W, Webb R, et al. Efficacy and safety of sacubitril/valsartan compared with olmesartan in Asian patients with essential hypertension: a randomized, double-blind, 8-week study. J Clin Hypertens (Greenwich), 2019, 21(1): 67-76.
26. Schmieder RE, Wagner F, Mayr M, et al. The effect of sacubitril/valsartan compared to olmesartan on cardiovascular remodelling in subjects with essential hypertension: the results of a randomized, double-blind, active-controlled study. Eur Heart J, 2017, 38(44): 3308-3317.
27. 国家卫生健康委员会疾病预防控制局, 国家心血管病中心, 中国医学科学院阜外医院, 等. 中国高血压健康管理规范(2019). 中华心血管病杂志, 2020, 48(1): 10-46.
28. Zhou M, Wang H, Zeng X, et al. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the global burden of disease study 2017. Lancet, 2019, 394(10204): 1145-1158.
29. 黄文博, 冯娴, 姚元龙, 等. 全科医学视角下我国高血压患者的自我管理. 中华全科医学, 2022, 20(7): 1085-1088.
30. Ma TK, Kam KK, Yan BP, et al. Renin-angiotensin-aldosterone system blockade for cardiovascular diseases: current status. Br J Pharmacol, 2010, 160(6): 1273-1292.
31. 张薇琳, 周海英, 杨小明. 双效血管紧张素受体-脑啡肽酶抑制剂沙库巴曲/缬沙坦的研究进展. 世界临床药物, 2017, 38(12): 851-854.
32. 赖朝辉, 刘迎午, 王禹, 等. 沙库巴曲缬沙坦钠对射血分数减低的心力衰竭合并高血压患者血压及相关指标变化的研究. 中华老年心脑血管病杂志, 2022, 24(1): 11-13.

Chinese Journal of Evidence-Based Medicine

Efficacy and safety of sacubitril valsartan in the treatment of hypertension: a meta-analysis

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