References

cardiovascular

Кардиоваскулярная терапия и профилактика

Cardiovascular Therapy and Prevention

1728-88002619-0125

«SILICEA-POLIGRAF» LLC

10.15829/1728-8800-2023-3636

OVRQKP

cardiovascular-3636

Research Article

ОБЗОРЫ ЛИТЕРАТУРЫ

REVIEW ARTICLES

Опыт применения сакубитрил/валсартана в лечении артериальной гипертонии

Experience of sacubitril/valsartan therapy in hypertension

https://orcid.org/0000-0003-4534-9890

Ощепкова

Е. В.

Oshchepkova

E. V.

Ощепкова Елена В. — доктор медицинских наук, профессор, главный научный сотрудник отдела гипертонии НИИ клинической кардиологии им. А.Л. Мясникова.

Москва

Moscow

arthyplab@list.ru

ФГБУ "Национальный медицинский исследовательский центр кардиологии им. акад. Е.И. Чазова" Минздрава РоссииE.I. Chazov National Medical Research Center of Cardiology

2023

05092023

22736363636

2023

Ощепкова Е.В.

Oshchepkova E.V.

Данная работа распространяется под лицензией Creative Commons Attribution 4.0.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://cardiovascular.elpub.ru/jour/article/view/3636

Цель обзора — провести анализ антигипертензивной эффективности и безопасности комбинации сакубитрил/валсартан (сак/ валс), представителя нового класса ингибиторов рецепторов ангиотензина II/неприлизина (АРНИ), у пациентов с артериальной гипертонией (АГ) по данным клинических исследований, в т.ч. рандомизированных, и метаанализов, опубликованных в открытой печати. Рандомизированные клинические исследования, проведенные в разных возрастных, этнических и клинических когортах пациентов с АГ, а также выполненные метаанализы показали более значимый антигипертензивный эффект сак/валс по сравнению с монотерапией блокаторами рецепторов ангиотензина II, подтвержденный данными офисного артериального давления (АД) и 24-часового мониторирования АД. При 1-2 ст. АГ при сравнении сак/валс с валсартаном или олмесартаном продемонстрирована бóльшая степень снижения систолического и диастолического АД на ~5/2 мм рт.ст. в исследованиях продолжительностью 8-12 нед. Установлен дозозависимый эффект сак/валс. Получен положительный опыт применения сак/ валс при разных клинических вариантах АГ (рефрактерная АГ, изолированная систолическая АГ у пожилых, АГ в сочетании с хронической сердечной недостаточностью, с хронической болезнью почек), а также успешного использования сак/валс в комбинации с другими антигипертензивными препаратами. В длительных исследованиях (52 нед.) у пожилых пациентов с АГ показаны положительные эффекты сак/валс в снижении центрального аортального давления, систолического АД в ночные часы и уменьшении пульсового АД. Несколько метаанализов показали одинаковые профили переносимости по сравнению с контрольными группами и отсутствие повышенного риска нежелательных явлений.

The aim of the review was to analyze the antihypertensive efficacy and safety of sacubitril/valsartan combination, a representative of a new class of angiotensin receptor-neprilysin inhibitors (ARNIs), in patients with hypertension (HTN) according to clinical trials, including randomized, and meta-analyses. Randomized clinical trials conducted in different age, ethnic and clinical cohorts of HTN patients, as well as meta-analyses showed a more significant antihypertensive effect of sacubitril/valsartan compared with monotherapy with angiotensin II receptor blockers, confirmed by office blood pressure (BP) and 24-hour BP monitoring. At grade 1-2 HTN, sacubitril/valsartan showed greater reduction in systolic and diastolic blood pressure by ~5/2 mm Hg compared to valsartan or olmesartan according to 8-12-week studies. A dose-dependent effect of sacubitril/valsartan was established. A favorable experience was obtained with sacubitril/ valsartan use in various clinical variants of HTN (refractory HTN, isolated systolic HTN in the elderly, HTN in combination with heart failure, with chronic kidney disease), as well as the successful use of sac/vals in combination with other antihypertensive drugs. In long-term studies (52 weeks) in elderly patients with HTN, the positive effects of sacubitril/valsartan in reducing central aortic pressure, systolic blood pressure at night and a decrease in pulse pressure have been shown. Several meta-analyses have shown similar tolerability profiles compared to controls and no increased risk of adverse events.

артериальная гипертониясердечно-сосудистые заболеванияантигипертензивные препаратынатрийуретические пептидыкласс ингибиторов ангиотензиновых рецепторов и неприлизинахроническая сердечная недостаточность

hypertensioncardiovascular diseasesantihypertensive drugsnatriuretic peptidesclass of angiotensin receptor-neprilysin inhibitorsheart failure

нет

none

References1

Yusuf S, Joseph P, Rangarajan S, et al. Modifiable risk factors, cardiovascular disease, and mortality in 155 722 individuals from 21 high-income, middle-income, and lowincome countries (PURE): a prospective cohort study. Lancet. 2020;395(10226):795-808. doi:10.1016/S0140-6736(19)320082. Erratum in: Lancet. 2020;395(10226):784.

Williams B, Mancia G, Spiering W, et al. 2018 Practice Guidelines for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. Blood Press. 2018;27(6):314-40. doi:10.1080/08037051.2018.1527177. Erratum in: Blood Press. 2019;28(1):74.

Бойцов С. А., Баланова Ю. А., Шальнова С. А. и др. Артериальная гипертония среди лиц 25-64 лет: распространенность, осведомленность, лечение и контроль. По материалам исследования ЭССЕ. Кардиоваскулярная терапия и профилактика. 2014;13(4):4-14. doi:10.15829/1728-88002014-4-4-14.

Boytsov SA, Balanova YuA, Shalnova SA, et al. Arterial hypertension among people aged 25-64: prevalence, awareness, treatment and control. Based on the materials of the ESSAY study. Cardiovascular Therapy and Prevention. 2014;13(4):4-14. (In Russ.) doi:10.15829/1728-88002014-4-4-14.

Аксенова А. В., Ощепкова Е. В., Чазова И. Е. Лечение больных артериальной гипертонией в реальной клинической практике в 2010-2020 гг. (по данным национального регистра артериальной гипертонии). Терапевтический архив. 2022;94(1):9-17. doi:10.26442/00403660.2022.01.201318.

Aksenova AV, Oshchepkova EV, Chazova IE. Treatment of patients with arterial hypertension in real clinical practice in 2010-2020. (according to the national Register of arterial hypertension). Therapeutic Archive. 2022;94(1):9-17. (In Russ.) doi:10.26442/00403660.2022.01.201318.

Kearney PM, Whelton M, Reynolds K, et al. Global burden of hypertension: analysis of worldwide data. Lancet. 2005;365(9455):217-23. doi:10.1016/S0140-6736(05)17741-1.

Franklin SS, Gustin W 4th, Wong ND, et al. Hemodynamic patterns of age-related changes in blood pressure. The Framingham Heart Study. Circulation. 1997;96(1):308-15. doi:10.1161/01.cir.96.1.308.

Franklin SS, Jacobs MJ, Wong ND, et al. Predominance of isolated systolic hypertension among middle-aged and elderly US hypertensives: analysis based on National Health and Nutrition Examination Survey (NHANES) III. Hypertension. 2001;37(3):86974. doi:10.1161/01.hyp.37.3.869.

Unger T, Borghi C, Charchar F, et al. 2020 International Society of Hypertension global hypertension practice guidelines. J Hypertens. 2020;38(6):982-1004. doi:10.1097/HJH.0000000000002453.

Muntner P, Hardy ST, Fine LJ, et al. Trends in Blood Pressure Control Among US Adults With Hypertension, 1999-2000 to 2017-2018. JAMA. 2020;324(12):1190-200. doi:10.1001/jama.2020.14545.

Sigmund CD, Carey RM, Appel LJ, et al. Report of the National Heart, Lung, and Blood Institute Working Group on Hypertension: Barriers to Translation. Hypertension. 2020;75(4):902-17. doi:10.1161/HYPERTENSIONAHA.119.13887.

Кобалава Ж. Д., Конради А. О., Недогода С. В. и др. Артериальная гипертензия у взрослых. Клинические рекомендации 2020. Российский кардиологический журнал. 2020;25(3):3786. doi:10.15829/1560-4071-2020-3-3786.

Kobalava ZhD, Konradi AO, Nedogoda VV, et al. Arterial hypertension in adults. Clinical Guidelines 2020. Russian Journal of Cardiology. 2020;25(3):3786. (In Russ.) doi:10.15829/1560-4071-2020-3-3786.

Чазова И. Е., Жернакова Ю. В. от имени экспертов. Клинические рекомендации. Диагностика и лечение артериальной гипертонии. Системные гипертензии. 2019;16(1):6-31. doi:10.26442/2075082X.2019.1.190179.

Chazova IE, Zhernakova YuV, on behalf of experts. Clinical recommendations. Diagnosis and treatment of arterial hypertension. Systemic hypertension. 2019;16(1):6-31. (In Russ.) doi:10.26442/2075082X.2019.1.190179.

Cannone V, Burnett JC Jr. Natriuretic Peptides and Blood Pressure Homeostasis: Implications for MANP, a Novel Guanylyl Cyclase a Receptor Activator for Hypertension. Front Physiol. 2022;12:815796. doi:10.3389/fphys.2021.815796.

Suga S, Itoh H, Komatsu Y, et al. Cytokine-induced C-type natriuretic peptide (CNP) secretion from vascular endothelial cells — evidence for CNP as a novel autocrine/ paracrine regulator from endothelial cells. Endocrinology. 1993;133(6):3038-41. doi:10.1210/endo.133.6.8243333.

Lee CY, Burnett JC Jr. Natriuretic peptides and therapeutic applications. Heart Fail Rev. 2007;12(2):131-42. doi:10.1007/s10741-007-9016-3.

Andersen MB, Simonsen U, Wehland M, et al. LCZ696 (Valsartan/ Sacubitril) — A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016;118(1):14-22. doi:10.1111/bcpt.12453.

Miller WL, Phelps MA, Wood CM, et al. Comparison of mass spectrometry and clinical assay measurements of circulating fragments of B-type natriuretic peptide in patients with chronic heart failure. Circ Heart Fail. 2011;4(3):355-60. doi:10.1161/CIRCHEARTFAILURE.110.960260.

Newton-Cheh C, Larson MG, Vasan RS, et al. Association of common variants in NPPA and NPPB with circulating natriuretic peptides and blood pressure. Nat Genet. 2009;41(3):348-53. doi:10.1038/ng.328.

Mangiafico S, Costello-Boerrigter LC, Andersen IA, et al. Neutral endopeptidase inhibition and the natriuretic peptide system: an evolving strategy in cardiovascular therapeutics. Eur Heart J. 2013;34(12):886-93. doi:10.1093/eurheartj/ehs262.

d’Uscio LV, Lüscher TF. Vasopeptidase inhibition and endothelial function in hypertension. Curr Hypertens Rep. 2001;3 Suppl 2:S614. doi:10.1007/s11906-001-0101-z.

De Vecchis R, Ariano C, Soreca S. A New Approach for Hypertension: the Case of Sacubitril/Valsartan Experienced in Randomized Controlled Trials That Selectively Restrict Its Use to the Hypertension of the Elderly. J Clin Med Res. 2018;10(11):853-4. doi:10.14740/jocmr3593w.

Geng Q, Yan R, Wang Z, Hou F. Effects of LCZ696 (Sacubitril/ Valsartan) on Blood Pressure in Patients with Hypertension: A Meta-Analysis of Randomized Controlled Trials. Cardiology. 2020;145(9):589-98. doi:10.1159/000507327.

Ruilope LM, Dukat A, Böhm M, et al. Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, doubleblind, placebo-controlled, active comparator study. Lancet. 2010;375(9722):1255-66. doi:10.1016/S0140-6736(09)61966-8.

Safar ME. Systolic blood pressure, pulse pressure and arterial stiff ness as cardiovascular risk factors. Curr Opin Nephrol Hypertens 2001;10:257-61. doi:10.1097/00041552-20010300000015.

Haider AW, Larson MG, Franklin SS, Levy D; Framingham Heart Study. Systolic blood pressure, diastolic blood pressure, and pulse pressure as predictors of risk for congestive heart failure in the Framingham Heart Study. Ann Intern Med. 2003;138(1):10-6. doi:10.7326/0003-4819-138-1-200301070-00006.

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):150-8. doi:10.1111/jch.13153.

Lewington S, Clarke R, Qizilbash N, et al. Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360(9349):1903-13. doi:10.1016/s0140-6736(02)11911-8. Erratum in: Lancet. 2003;361(9362):1060.

Perkovic V, Huxley R, Wu Y, et al. The burden of blood pressurerelated disease: a neglected priority for global health. Hypertension. 2007;50(6):991-7. doi:10.1161/HYPERTENSIONAHA.107.095497.

Franklin SS, Neutel JM. Initial combination therapy for rapid and effective control of moderate and severe hypertension. J Hum Hypertens. 2009;23(1):4-11. doi:10.1038/jhh.2008.72.

Kario K, Tamaki Y, Okino N, et al. LCZ696, a First-in-Class Angiotensin Receptor-Neprilysin Inhibitor: The First Clinical Experience in Patients With Severe Hypertension. J Clin Hypertens (Greenwich). 2016;18(4):308-14. doi:10.1111/jch.12667.

McMurray JJ, Packer M, Desai AS, et al.; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):9931004. doi:10.1056/NEJMoa1409077.

Du H, Li X, Zhao W, Jiang N. The Difference between Sacubitril Valsartan and Valsartan on Vascular Endothelial Function, APN, MMP-9, and BNP Levels in Patients with Hypertension and Chronic Heart Failure. J Healthc Eng. 2022;2022:9494981. doi:10.1155/2022/9494981.

Jackson AM, Jhund PS, Anand IS, et al. Sacubitril-valsartan as a treatment for apparent resistant hypertension in patients with heart failure and preserved ejection fraction. Eur Heart J. 2021;42(36):3741-52. doi:10.1093/eurheartj/ehab499.

Rossignol P, Claggett BL, Liu J, et al. Spironolactone and Resistant Hypertension in Heart Failure With Preserved Ejection Fraction. Am J Hypertens. 2018;31(4):407-14. doi:10.1093/ajh/hpx210.

Jin CN, Liu M, Sun JP, et al. The prevalence and prognosis of resistant hypertension in patients with heart failure. PLoS One. 2014;9(12):e114958. doi:10.1371/journal.pone.0114958.

Li W, Gong M, Yu Q, et al. Efficacy of angiotensin receptor neprilysin inhibitor in Asian patients with refractory hypertension. J Clin Hypertens (Greenwich). 2022;24(4):449-56. doi:10.1111/jch.14454.

Williams B, Cockcroft JR, Kario K, et all. Effects of Sacubitril/ Valsartan Versus Olmesartan on Central Hemodynamics in the Elderly With Systolic Hypertension The PARAMETER Study. Hyper tension. 2017;69:411-20. doi:10.1161/HYPERTENSIONAHA.116.08556.

Izzo JL Jr, Zappe DH, Jia Y, et al. Efficacy and Safety of Crystalline Valsartan/Sacubitril (LCZ696) Compared With Placebo and Combinations of Free Valsartan and Sacubitril in Patients With Systolic Hypertension: The RATIO Study. J Cardiovasc Pharmacol. 2017;69(6):374-81. doi:10.1097/FJC.0000000000000485.

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):1163-9. doi:10.1093/ajh/hpx111.

Rakugi H, Kario K, Yamaguchi M, et al. Efficacy of sacubitril/ valsartan versus olmesartan in Japanese patients with essential hypertension: a randomized, double-blind, multicenter study. Hypertens Res. 2022;45(5):824-33. doi:10.1038/s41440-02100819-7.

Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2016;387(10022):957-67. doi:10.1016/S0140-6736(15)01225-8.

Wang JG, Yukisada K, Sibulo A Jr, et al. Efficacy and safety of sacubitril/valsartan (LCZ696) add-on to amlodipine in Asian patients with systolic hypertension uncontrolled with amlodipine monotherapy. J Hypertens. 2017;35(4):877-85. doi:10.1097/ HJH.0000000000001219.

Cavalcante JL, Lima JA, Redheuil A, Al-Mallah MH. Aortic stiffness: current understanding and future directions. J Am Coll Cardiol. 2011;57(14):1511-22. doi:10.1016/j.jacc.2010.12.017.

Redheuil A, Wu CO, Kachenoura N, et al. Proximal aortic distensibility is an independent predictor of all-cause mortality and incident CV events: the MESA study. J Am Coll Cardiol. 2014;64(24):2619-29. doi:10.1016/j.jacc.2014.09.060.

Mitchell GF, Hwang SJ, Vasan RS, et al. Arterial stiffness and cardiovascular events: the Framingham Heart Study. Circulation. 2010;121(4):505-11. doi:10.1161/CIRCULATIONAHA.109.886655.

Heeneman S, Sluimer JC, Daemen MJ. Angiotensin-converting enzyme and vascular remodeling. Circ Res. 2007;101(5):441-54. doi:10.1161/CIRCRESAHA.107.148338.

Schiffrin EL. Circulatory therapeutics: use of antihypertensive agents and their effects on the vasculature. J Cell Mol Med. 2010;14(5):1018-29. doi:10.1111/j.1582-4934.2010.01056.x.

Bavishi C, Messerli FH, Kadosh B, et al. Role of neprilysin inhibitor combinations in hypertension: insights from hypertension and heart failure trials. Eur Heart J. 2015;36:1967-73.

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):3308-17. doi:10.1093/eurheartj/ehx525.

Myhre PL, Selvaraj S, Solomon SD. Management of hypertension in heart failure with preserved ejection fraction: is there a blood pressure goal? Curr Opin Cardiol. 2021;36(4):413-9. doi:10.1097/HCO.0000000000000852.

To TL, Doan TN, Ho WC, Liao WC. Prevalence of Frailty among Community-Dwelling Older Adults in Asian Countries: A Systematic Review and Meta-Analysis. Healthcare (Basel). 2022;10(5):895. doi:10.3390/healthcare10050895.

Tamura Y, Ishikawa J, Fujiwara Y, et al. Prevalence of frailty, cognitive impairment, and sarcopenia in outpatients with cardiometabolic disease in a frailty clinic. BMC Geriatr. 2018;18(1):264. doi:10.1186/s12877-018-0955-4.

Li X, Zuo C, Chen C, et al. Effectiveness and safety evaluation of sacubitril/valsartan in blood pressure control and clinical outcomes for elderly patients with heart failure and hypertension: A prospective cohort study. Int J Cardiol. 2023;371:244-51. doi:10.1016/j.ijcard.2022.09.050.

Kanenawa K, Isotani A, Yamaji K, et al. The impact of frailty according to Clinical Frailty Scale on clinical outcome in patients with heart failure. ESC Heart Fail. 2021;8(2):1552-61. doi:10.1002/ehf2.13254.

Wang TD, Tan RS, Lee HY, et al. Effects of sacubitril/valsartan (LCZ696) on natriuresis, blood pressures, and NT-proBNP in salt sensitive hypertension. Hypertension. 2017;69(1):32-41. doi:10.1161/HYPERTENSIONAHA.116.08484.

Bidani AK, Griffin KA. Pathophysiology of hypertensive renal damage: implications for therapy. Hypertension. 2004;44:595601. doi:10.1161/01.HYP.0000145180.38707.84.

Hill NR, Fatoba ST, Oke JL, et al. Global Prevalence of Chronic Kidney Disease — A Systematic Review and Meta-Analysis. PLoS One. 2016;11(7):e0158765. doi:10.1371/journal.pone.0158765.

Ощепкова Е. В., Долгушева Ю. А., Жернакова Ю. В. и др. Распространенность нарушения функции почек при артериальной гипертонии (по данным эпидемиологического исследования ЭССЕ-РФ). Системные гипертензии. 2015;12(3):19-24.

Oshchepkova EV, Dolgusheva YuA, Zhernakova YuV, et al. Prevalence of renal dysfunction in arterial hypertension (according to the epidemiological study of ESSE-RF). Systemic hypertension. 2015;12(3):19-24. (In Russ.)

Konta T, Ikeda A, Ichikawa K, et al. Blood pressure control in a Japanese population with chronic kidney disease: a baseline survey of a nationwide cohort. Am J Hypertens. 2012;25(3):342-7. doi:10.1038/ajh.2011.217.

Plantinga LC, Miller ER 3rd, Stevens LA, et al.; Centers for Disease Control and Prevention Chronic Kidney Disease Surveillance Team. Blood pressure control among persons without and with chronic kidney disease: US trends and risk factors 1999-2006. Hypertension. 2009;54(1):47-56. doi:10.1161/HYPERTENSIONAHA.109.129841.

Ito S, Satoh M, Tamaki Y, et al. Safety and efficacy of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Japanese patients with hypertension and renal dysfunction. Hypertens Res. 2015;38(4):269-75. doi:10.1038/hr.2015.1.

Malik AH, Aronow WS. Efficacy of Sacubitril/Valsartan in Hypertension. Am J Ther. 2022;29(3):e322-33. doi:10.1097/MJT.0000000000000925.

Anderson SL, Marrs JC. Sacubitril/valsartan: evaluation of safety and efficacy as an antihypertensive treatment. Drugs Context. 2018;7:212542.

Hong-Xing Wu, Ke-Ke Liu, Bo-Ning Li, et al. Efficacy and safety of sacubitril/valsartan in the treatment of middle-aged and elderly patients with hypertension: a systematic review and meta-analysis of randomized controlled trials. Ann Palliat Med. 2022;11(5):1811-25. doi:10.21037/apm-22-503.

Chrysant SG. Benefits and pitfalls of sacubitril/valsartan treatment in patients with hypertension. J Clin Hypertens (Greenwich). 2018;20(2):351-5. doi:10.1111/jch.13169.

Jordan J, Stinkens R, Jax T, et al. Improved insulin sensitivity with angiotensin receptor neprilysin inhibition in individuals with obesity hypertension. Clin Pharmacol Ther. 2017;101:254-63. doi:10.1002/cpt.455.

Wehland M, Simonsen U, Buus NH, et al. An evaluation of the fixed-dose combination sacubitril/valsartan for the treatment of arterial hypertension. Expert Opin Pharmacother. 2020;21(10):1133-43. doi:10.1080/14656566.2020.1735356.

Rose JB, Crews L, Rockenstein E, et al. Neuropeptide Y fragments derived from neprilysin processing are neuroprotective in a transgenic model of Alzheimer’s disease. J Neurosci. 2009;29(4):1115-25. doi:10.1523/JNEUROSCI.4220-08.2009.

Ohno-Matsui K. Parallel findings in age-related macular degeneration and Alzheimer disease. Prog Retin Eye Res. 2011;30(4):217-38. doi:10.1016/j.preteyeres.2011.02.004.

The authors declare that there are no conflicts of interest present.