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

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, 楊瑛, 王文, 等. 我國高血壓流行新特征—中國高血壓調查的亮點和啟示. 中國循環雜志, 2018, 33(10): 937-939.
3.	中國高血壓防治指南修訂委員會, 高血壓聯盟(中國), 中華醫學會心血管病學分會中國醫師協會高血壓專業委員會, 等. 中國高血壓防治指南(2018年修訂版). 中國心血管雜志, 2019, 24(1): 24-56.
4.	中國醫療保健國際交流促進會高血壓分會, 中國醫師協會心血管分會, 中國高血壓聯盟, 等. 沙庫巴曲纈沙坦在高血壓患者臨床應用的中國專家建議. 中華高血壓雜志, 2021, 29(2): 108-114.
5.	中華醫學會, 中華醫學會雜志社, 中華醫學會全科醫學分會, 等. 高血壓基層診療指南(實踐版·2019). 中華全科醫師雜志, 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.	曾憲濤, 包翠萍, 曹世義, 等. Meta分析系列之三: 隨機對照試驗的質量評價工具. 中國循證心血管醫學雜志, 2012, 4(3): 183-185.
9.	曾憲濤, 熊期, 沈可. Meta分析系列之十三: 盲法的評價. 中國循證心血管醫學雜志, 2013, 5(4): 331-333.
10.	曾憲濤, 黃偉, 沈可. Meta分析系列之十一: 隨機化的評價. 中國循證心血管醫學雜志, 2013, 5(2): 101-103.
11.	曾憲濤, 沈可, 羅杰. Meta分析系列之十二: 分配隱藏的評價. 中國循證心血管醫學雜志, 2013, 5(3): 219-221.
12.	曾憲濤, Joey SWK, 田國祥, 等. Meta分析系列之二: Meta分析的軟件. 中國循證心血管醫學雜志, 2012, 4(2): 89-91.
13.	Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med, 2002, 21(11): 1539-1558.
14.	楊娟, 鄭青山. Meta分析的統計學方法. 中國臨床藥理學與治療學, 2005, 10(11): 1309-1314.
15.	康德英, 洪旗, 劉關鍵, 等. Meta分析中發表性偏倚的識別與處理. 中國循證醫學雜志, 2003, 3(1): 45-49.
16.	張存新, 陳俊華. 沙庫巴曲纈沙坦治療原發性高血壓并射血分數保留心力衰竭的療效. 武警醫學, 2020, 31(12): 1017-1020.
17.	任智超, 何廉旗, 張建, 等. 沙庫巴曲纈沙坦治療鹽敏感性高血壓的效果分析. 中國當代醫藥, 2022, 29(4): 79-81.
18.	何愛榮, 薛德剛, 韓笑. 沙庫巴曲纈沙坦治療高血壓合并左心室肥厚患者的療效分析. 中國實用醫藥, 2022, 17(17): 107-109.
19.	張大喜, 李愛霞, 王鮮. 沙庫巴曲纈沙坦治療高血壓合并射血分數保留心力衰竭患者臨床觀察. 社區醫學雜志, 2022, 20(8): 440-444.
20.	時慶平, 蘭玲, 尹麗君, 等. 沙庫巴曲纈沙坦用于老年高血壓心臟病的效果觀察. 老年醫學與保健, 2021, 27(5): 944-947.
21.	高峰. 老年高血壓治療過程中采用沙庫巴曲纈沙坦治療的效果研究. 中西醫結合心血管病電子雜志, 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.	國家衛生健康委員會疾病預防控制局, 國家心血管病中心, 中國醫學科學院阜外醫院, 等. 中國高血壓健康管理規范(2019). 中華心血管病雜志, 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.	黃文博, 馮嫻, 姚元龍, 等. 全科醫學視角下我國高血壓患者的自我管理. 中華全科醫學, 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.	張薇琳, 周海英, 楊小明. 雙效血管緊張素受體-腦啡肽酶抑制劑沙庫巴曲/纈沙坦的研究進展. 世界臨床藥物, 2017, 38(12): 851-854.
32.	賴朝輝, 劉迎午, 王禹, 等. 沙庫巴曲纈沙坦鈉對射血分數減低的心力衰竭合并高血壓患者血壓及相關指標變化的研究. 中華老年心腦血管病雜志, 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, 楊瑛, 王文, 等. 我國高血壓流行新特征—中國高血壓調查的亮點和啟示. 中國循環雜志, 2018, 33(10): 937-939.
3. 中國高血壓防治指南修訂委員會, 高血壓聯盟(中國), 中華醫學會心血管病學分會中國醫師協會高血壓專業委員會, 等. 中國高血壓防治指南(2018年修訂版). 中國心血管雜志, 2019, 24(1): 24-56.
4. 中國醫療保健國際交流促進會高血壓分會, 中國醫師協會心血管分會, 中國高血壓聯盟, 等. 沙庫巴曲纈沙坦在高血壓患者臨床應用的中國專家建議. 中華高血壓雜志, 2021, 29(2): 108-114.
5. 中華醫學會, 中華醫學會雜志社, 中華醫學會全科醫學分會, 等. 高血壓基層診療指南(實踐版·2019). 中華全科醫師雜志, 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. 曾憲濤, 包翠萍, 曹世義, 等. Meta分析系列之三: 隨機對照試驗的質量評價工具. 中國循證心血管醫學雜志, 2012, 4(3): 183-185.
9. 曾憲濤, 熊期, 沈可. Meta分析系列之十三: 盲法的評價. 中國循證心血管醫學雜志, 2013, 5(4): 331-333.
10. 曾憲濤, 黃偉, 沈可. Meta分析系列之十一: 隨機化的評價. 中國循證心血管醫學雜志, 2013, 5(2): 101-103.
11. 曾憲濤, 沈可, 羅杰. Meta分析系列之十二: 分配隱藏的評價. 中國循證心血管醫學雜志, 2013, 5(3): 219-221.
12. 曾憲濤, Joey SWK, 田國祥, 等. Meta分析系列之二: Meta分析的軟件. 中國循證心血管醫學雜志, 2012, 4(2): 89-91.
13. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med, 2002, 21(11): 1539-1558.
14. 楊娟, 鄭青山. Meta分析的統計學方法. 中國臨床藥理學與治療學, 2005, 10(11): 1309-1314.
15. 康德英, 洪旗, 劉關鍵, 等. Meta分析中發表性偏倚的識別與處理. 中國循證醫學雜志, 2003, 3(1): 45-49.
16. 張存新, 陳俊華. 沙庫巴曲纈沙坦治療原發性高血壓并射血分數保留心力衰竭的療效. 武警醫學, 2020, 31(12): 1017-1020.
17. 任智超, 何廉旗, 張建, 等. 沙庫巴曲纈沙坦治療鹽敏感性高血壓的效果分析. 中國當代醫藥, 2022, 29(4): 79-81.
18. 何愛榮, 薛德剛, 韓笑. 沙庫巴曲纈沙坦治療高血壓合并左心室肥厚患者的療效分析. 中國實用醫藥, 2022, 17(17): 107-109.
19. 張大喜, 李愛霞, 王鮮. 沙庫巴曲纈沙坦治療高血壓合并射血分數保留心力衰竭患者臨床觀察. 社區醫學雜志, 2022, 20(8): 440-444.
20. 時慶平, 蘭玲, 尹麗君, 等. 沙庫巴曲纈沙坦用于老年高血壓心臟病的效果觀察. 老年醫學與保健, 2021, 27(5): 944-947.
21. 高峰. 老年高血壓治療過程中采用沙庫巴曲纈沙坦治療的效果研究. 中西醫結合心血管病電子雜志, 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. 國家衛生健康委員會疾病預防控制局, 國家心血管病中心, 中國醫學科學院阜外醫院, 等. 中國高血壓健康管理規范(2019). 中華心血管病雜志, 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. 黃文博, 馮嫻, 姚元龍, 等. 全科醫學視角下我國高血壓患者的自我管理. 中華全科醫學, 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. 張薇琳, 周海英, 楊小明. 雙效血管緊張素受體-腦啡肽酶抑制劑沙庫巴曲/纈沙坦的研究進展. 世界臨床藥物, 2017, 38(12): 851-854.
32. 賴朝輝, 劉迎午, 王禹, 等. 沙庫巴曲纈沙坦鈉對射血分數減低的心力衰竭合并高血壓患者血壓及相關指標變化的研究. 中華老年心腦血管病雜志, 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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