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Application of Angiotensin Receptor-Neprilysin Inhibitor in Chronic Kidney Disease Patients: Chinese Expert Consensus

  • ZUO Li ,
  • GAN Liang-Ying ,
  • GAN Liang-Ying Xiao-Xi ,
  • YANG Xiang-Dong ,
  • ZHAO Zhan-Zheng ,
  • TANG Ying ,
  • CHEN Yuan-Han ,
  • YAO Ying ,
  • HONG Fu-Yuan ,
  • XU Zhong-Gao ,
  • CHEN Ji-Hong ,
  • GU Le-Yi ,
  • MAO Hui-Juan ,
  • LIU Ying ,
  • SUN Jing ,
  • ZHOU Zhu ,
  • DU Xuan-Yi ,
  • JIANG Hong ,
  • LI Yong ,
  • SUN Ning-Ling ,
  • LIANG Xin-Ling
Expand
  • Zhongguancun Nephrology & Blood Purification Innovation Alliance, Beijing 100044, China

Received date: 2022-09-26

  Revised date: 2022-11-22

  Online published: 2023-04-12

Abstract

Chronic kidney disease (CKD) is a global public health problem, and cardiovascular disease is the most common cause of death in patients with CKD. The incidence and prevalence of cardiovascular events during the early stages of CKD increases significantly with a decline in renal function. More than 50% of dialysis patients die from cardiovascular disease. Therefore, developing effective methods to control risk factors and improve prognosis of cardiovascular disease is the primary focus during the diagnosis and treatment of CKD. For example, the Systolic blood pressure intervention trial (SPRINT) study demonstrated that CKD drugs are effective in reducing cardiovascular and cerebrovascular events by controlling blood pressure. Uncontrolled blood pressure not only increases the risk of these events but also accelerates the progression of CKD. Recent studies have repeatedly confirmed that the first and so far the only angiotensin receptor–neprilysin inhibitor (ARNI) sacubitril/valsartan can reduce blood pressure more effectively than renin–angiotensin system inhibitors and improve the prognosis of heart failure in patients with CKD. Here, to better guide the application of ARNI in patients with CKD, and reduce the occurrence of cardiovascular events,we formulate a consensus based on clinical evidence and experience.

Cite this article

ZUO Li , GAN Liang-Ying , GAN Liang-Ying Xiao-Xi , YANG Xiang-Dong , ZHAO Zhan-Zheng , TANG Ying , CHEN Yuan-Han , YAO Ying , HONG Fu-Yuan , XU Zhong-Gao , CHEN Ji-Hong , GU Le-Yi , MAO Hui-Juan , LIU Ying , SUN Jing , ZHOU Zhu , DU Xuan-Yi , JIANG Hong , LI Yong , SUN Ning-Ling , LIANG Xin-Ling . Application of Angiotensin Receptor-Neprilysin Inhibitor in Chronic Kidney Disease Patients: Chinese Expert Consensus[J]. Chinese Journal of Blood Purification, 2023 , 22(04) : 241 -253 . DOI: 10.3969/j.issn.1671-4091.2023.04.001

References

[1] Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022[J]. Kidney Int Suppl. (2011) 12:7–11.
[2] Bikbov B , Purcell C A , Levey A S , et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017[J]. The Lancet, 2020, 395(10225):709-733.
[3] Stevens PE, Levin A, Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group M. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline[J]. Ann Intern Med.(2013) 158:825–830.
[4] Jankowski J, Floege J, Fliser D, et al. Cardiovascular Disease in Chronic Kidney Disease: Pathophysiological Insights and Therapeutic Options[J]. Circulation, 2021, 143(11): 1157-1172.
[5] Ryu H, Kim J, Kang E, et al. Incidence of cardiovascular events and mortality in Korean patients with chronic kidney disease[J]. Sci Rep, 2021, 11(1): 1131.
[6] United States Renal Data System. 2020 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. Bethesda, MD: National Institutes of Health; National Institute of Diabetes and Digestive and Kidney Diseases (2020).
[7] Zhao X, Niu Q, Gan L, et al. Thrombocytopenia predicts mortality in Chinese hemodialysis patients-an analysis of the China DOPPS[J]. BMC Nephrol. (2022) 23:11.
[8] Cai G, Zheng Y, Sun X, et al. Prevalence, awareness, treatment, and control of hypertension in elderly adults with chronic kidney disease: results from the survey of Prevalence, Awareness, and Treatment Rates in Chronic Kidney Disease Patients with Hypertension in China[J]. J Am Geriatr Soc, 2013, 61(12): 2160-2167.
[9] Zheng Y, Tang L, Zhang W, et al. Applying the new intensive blood pressure categories to a nondialysis chronic kidney disease population: the Prevalence, Awareness and Treatment Rates in Chronic Kidney Disease Patients with Hypertension in China survey[J]. Nephrol Dial Transplant, 2020, 35(1): 155-161.
[10] Hsu C Y, Mcculloch C E, Darbinian J, et al. Elevated blood pressure and risk of end-stage renal disease in subjects without baseline kidney disease[J]. Arch Intern Med, 2005, 165(8): 923-8.
[11] Paoletti E, De Nicola L, Gabbai F B, et al. Associations of Left Ventricular Hypertrophy and Geometry with Adverse Outcomes in Patients with CKD and Hypertension[J]. Clin J Am Soc Nephrol, 2016, 11(2): 271-279.
[12] Group S R, Wright J T Jr, Williamson J D, et al. A Randomized Trial of Intensive versus Standard Blood-Pressure Control[J]. N Engl J Med, 2015, 373(22): 2103-2116.
[13] Kidney Disease: Improving Global Outcomes Blood Pressure Work G. KDIGO 2021 Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease[J]. Kidney Int, 2021, 99(3S): S1-S87.
[14] Mishima E, Haruna Y, Arima H. Renin-angiotensin system inhibitors in hypertensive adults with non-diabetic CKD with or without proteinuria: a systematic review and meta-analysis of randomized trials[J]. Hypertens Res, 2019, 42(4): 469-482.
[15] Nagata D, Hishida E, Masuda T. Practical Strategy for Treating Chronic Kidney Disease (CKD)-Associated with Hypertension[J]. Int J Nephrol Renovasc Dis, 2020, 13: 171-178.
[16] https://reference.medscape.com/drug/entresto-sacubitril-valsartan-1000010
[17] Zheng Y, Cai G Y, Chen X M, et al. Prevalence, awareness, treatment, and control of hypertension in the non-dialysis chronic kidney disease patients[J]. Chin Med J (Engl), 2013, 126(12): 2276-2280.
[18] Damman K, Tang W H, Felker G M, et al. Current evidence on treatment of patients with chronic systolic heart failure and renal insufficiency: practical considerations from published data[J]. J Am Coll Cardiol, 2014, 63(9): 853-871.
[19] House A A, Wanner C, Sarnak M J, et al. Heart failure in chronic kidney disease: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference[J]. Kidney Int, 2019, 95(6): 1304-1317.
[20] Zhang R, Sun X, Li Y, et al. The efficacy and safety of sacubitril/valsartan in heart failure patients: A review[J]. J Cardiovasc Pharmacol Ther. (2022) 27:10742484211058681.
[21] Gondek A, Jagodzinska A, Pietrzak B, et al. Relevance of the assessment of natriuretic peptide plasma concentrations in hypertensive pregnant women[J]. Biomarkers, 2020, 25(6): 449-457.
[22] Zhang Y, Du X, Wang H, et al. Sacubitril-valsartan cocrystal revisited: role of polymer excipients in the formulation[J]. Expert Opin Drug Deliv, 2021, 18(4): 515-526.
[23] Mccormack P L. Sacubitril/Valsartan: A Review in Chronic Heart Failure with Reduced Ejection Fraction[J]. Drugs, 2016, 76(3): 387-396.
[24] Kuang H, Huang X, Zhou Z, et al. Sacubitril/valsartan in chronic kidney disease: From pharmacological mechanism to clinical application[J]. Eur J Pharmacol, 2021, 907: 174288.
[25] Ayalasomayajula S, Langenickel T, Pal P, et al. Erratum to: Clinical Pharmacokinetics of Sacubitril/Valsartan (LCZ696): A Novel Angiotensin Receptor-Neprilysin Inhibitor[J]. Clin Pharmacokinet, 2018, 57(1): 105-123.
[26] Kulmatycki K M, Langenickel T, Ng W H, et al. Pharmacokinetics and safety of sacubitril/valsartan (LCZ696) in patients with mild and moderate hepatic impairment[J]. Int J Clin Pharmacol Ther, 2017, 55(9): 728-739.
[27] Gu J, Noe A, Chandra P, et al. Pharmacokinetics and pharmacodynamics of LCZ696, a novel dual-acting angiotensin receptor-neprilysin inhibitor (ARNi)[J]. J Clin Pharmacol, 2010, 50(4): 401-414.
[28] Ruilope L M, Dukat A, Bohm M, et al. Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study[J]. Lancet, 2010, 375(9722): 1255-1266.
[29] Mcmurray J J, Packer M, Desai A S, et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure[J]. N Engl J Med, 2014, 371(11): 993-1004.
[30] Solomon S D, Mcmurray J J V, Anand I S, et al. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction[J]. N Engl J Med, 2019, 381(17): 1609-1620.
[31] Wachter R, Senni M, Belohlavek J, et al. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study[J]. Eur J Heart Fail, 2019, 21(8): 998-1007.
[32] Devore A D, Braunwald E, Morrow D A, et al. Initiation of Angiotensin-Neprilysin Inhibition After Acute Decompensated Heart Failure: Secondary Analysis of the Open-label Extension of the PIONEER-HF Trial[J]. JAMA Cardiol, 2020, 5(2): 202-207.
[33] Berg D D, Samsky M D, Velazquez E J, et al. Efficacy and Safety of Sacubitril/Valsartan in High-Risk Patients in the PIONEER-HF Trial[J]. Circ Heart Fail, 2021, 14(2): e007034.
[34] Zanchi A, Maillard M, Burnier M. Recent clinical trials with omapatrilat: new developments[J]. Curr Hypertens Rep, 2003, 5(4): 346-352.
[35] Docherty K F, Vaduganathan M, Solomon S D, et al. Sacubitril/Valsartan: Neprilysin Inhibition 5 Years After PARADIGM-HF[J]. JACC Heart Fail, 2020, 8(10): 800-810.
[36] Pradhan A, Vohra S, Vishwakarma P, et al. Review on sodium-glucose cotransporter 2 inhibitor (SGLT2i) in diabetes mellitus and heart failure[J]. J Family Med Prim Care, 2019, 8(6): 1855-1862.
[37] Solomon S D, Jhund P S, Claggett B L, et al. Effect of Dapagliflozin in Patients With HFrEF Treated With Sacubitril/Valsartan: The DAPA-HF Trial[J]. JACC Heart Fail, 2020, 8(10): 811-818.
[38] De La Espriella R, Bayes-Genis A, Morillas H, et al. Renal function dynamics following co-administration of sacubitril/valsartan and empagliflozin in patients with heart failure and type 2 diabetes[J]. ESC Heart Fail, 2020.
[39] Hsiao F C, Lin C P, Tung Y C, et al. Combining sodium-glucose cotransporter 2 inhibitors and angiotensin receptor-neprilysin inhibitors in heart failure patients with reduced ejection fraction and diabetes mellitus: A multi-institutional study[J]. Int J Cardiol, 2021, 330: 91-97.
[40] Hubers S A, Brown N J. Combined Angiotensin Receptor Antagonism and Neprilysin Inhibition[J]. Circulation, 2016, 133(11): 1115-1124.
[41] Ryu H, Kim J, Kang E, et al. Author Correction: Incidence of cardiovascular events and mortality in Korean patients with chronic kidney disease[J]. Sci Rep, 2021, 11(1): 9488.
[42] https://www.ema.europa.eu/en/documents/product-information/entresto-epar-product-information_en.pdf[J].
[43] Ayalasomayajula S, Langenickel T H, Chandra P, et al. Effect of food on the oral bioavailability of the angiotensin receptor - neprilysin inhibitor sacubitril/valsartan (LCZ696) in healthy subjects[J]. Int J Clin Pharmacol Ther, 2016, 54(12): 1012-1018.
[44] Damman K, Gori M, Claggett B, et al. Renal Effects and Associated Outcomes During Angiotensin- Neprilysin Inhibition in Heart Failure[J]. JACC Heart Fail. (2018) 6:489-498.
[45] Chang H Y, Feng A N, Fong M C, et al. Sacubitril/valsartan in heart failure with reduced ejection fraction patients: Real world experience on advanced chronic kidney disease, hypotension, and dose escalation[J]. J Cardiol, 2019, 74(4): 372-380.
[46] Spannella F, Marini M, Giulietti F, et al. Renal effects of Sacubitril/Valsartan in heart failure with reduced ejection fraction: a real life 1-year follow-up study[J]. Intern Emerg Med, 2019, 14(8): 1287-1297.
[47] Hsieh H L, Chen C Y, Chen C H, et al. Renal protective effect of sacubitril/valsartan in patients with heart failure[J]. Sci Rep, 2021, 11(1): 4593.
[48] Kang H, Zhang J, Zhang X, et al. Effects of sacubitril/valsartan in patients with heart failure and chronic kidney disease: A meta-analysis[J]. Eur J Pharmacol, 2020, 884: 173444.
[49] Kario K. The Sacubitril/Valsartan, a First-in-Class, Angiotensin Receptor Neprilysin Inhibitor (ARNI): Potential Uses in Hypertension, Heart Failure, and Beyond[J]. Curr Cardiol Rep, 2018, 20(1): 5.
[50] Geng Q, Yan R, Wang Z, et al. Effects of LCZ696 (Sacubitril/Valsartan) on Blood Pressure in Patients with Hypertension: A Meta-Analysis of Randomized Controlled Trials[J]. Cardiology, 2020, 145(9): 589-598.
[51] De Vecchis R, Ariano C, Soreca S. Antihypertensive effect of sacubitril/valsartan: a meta-analysis[J]. Minerva Cardioangiol, 2019, 67(3): 214-222.
[52] 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[J]. Hypertens Res, 2015, 38(4): 269-275.
[53] Williams B, Cockcroft J R, Kario K, et al. Effects of Sacubitril/Valsartan Versus Olmesartan on Central Hemodynamics in the Elderly With Systolic Hypertension: The PARAMETER Study[J]. Hypertension, 2017, 69(3): 411-420.
[54] Ayalasomayajula S P, Langenickel T H, Jordaan P, et al. Effect of renal function on the pharmacokinetics of LCZ696 (sacubitril/valsartan), an angiotensin receptor neprilysin inhibitor[J]. Eur J Clin Pharmacol, 2016, 72(9): 1065-1073.
[55] Ayalasomayajula S, Langenickel T, Pal P, et al. Clinical Pharmacokinetics of Sacubitril/Valsartan (LCZ696): A Novel Angiotensin Receptor-Neprilysin Inhibitor[J]. Clin Pharmacokinet, 2017, 56(12): 1461-1478.
[56] Kario K, Sun N, Chiang F T, et al. Efficacy and safety of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Asian patients with hypertension: a randomized, double-blind, placebo-controlled study[J]. Hypertension, 2014, 63(4): 698-705.
[57] Cheung D G, 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]. J Clin Hypertens (Greenwich), 2018, 20(1): 150-158.
[58] 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]. J Clin Hypertens (Greenwich), 2019, 21(1): 67-76.
[59] Schmieder R E, 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[J]. Eur Heart J, 2017, 38(44): 3308-3317.
[60] 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[J]. Am J Hypertens, 2017, 30(12): 1163-1169.
[61] Ferreira J P, Mogensen U M, Jhund P S, et al. Serum potassium in the PARADIGM-HF trial[J]. Eur J Heart Fail, 2020, 22(11): 2056-2064.
[62] Haynes R, Judge P K, Staplin N, et al. Effects of Sacubitril/Valsartan Versus Irbesartan in Patients With Chronic Kidney Disease[J]. Circulation, 2018, 138(15): 1505-1514.
[63] Fala L. Entresto (Sacubitril/Valsartan): First-in-Class Angiotensin Receptor Neprilysin Inhibitor FDA Approved for Patients with Heart Failure[J]. Am Health Drug Benefits, 2015, 8(6): 330-334.
[64] Expert group on early detection, diagnosis and treatment system construction of chronic kidney disease in Shanghai. Guideline for screening, diagnosis, prevention and treatment of chronic kidney disease[J]. Chin J Prac Intern Med. (2017) 37:28-34.
[65] Schernthaner G, Ritz E, Schernthaner G H. Strict glycaemic control in diabetic patients with CKD or ESRD: beneficial or deadly?[J]. Nephrol Dial Transplant, 2010, 25(7): 2044-2047.
[66] Gamarra E, Baffoni C, Borretta G, et al. Reduction of Insulin Requirement After Starting Treatment With Sacubitril/Valsartan in a Patient with Diabetes Treated With Continuous Subcutaneous Insulin Infusion (CSII): A case report[J]. J Diabetes Sci Technol, 2018, 12(6): 1254-1255.
[67] Jordan J, Stinkens R, Jax T, et al. Improved Insulin Sensitivity With Angiotensin Receptor Neprilysin Inhibition in Individuals With Obesity and Hypertension[J]. Clin Pharmacol Ther, 2017, 101(2): 254-263.
[68] De Vecchis R, Soreca S, Ariano C. Anti-Hypertensive Effect of Sacubitril/Valsartan: A Meta-Analysis of Randomized Controlled Trials[J]. Cardiol Res, 2019, 10(1): 24-33.
[69] 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]. J Clin Hypertens (Greenwich), 2016, 18(4): 308-314.
[70] Desai A S, Vardeny O, Claggett B, et al. Reduced Risk of Hyperkalemia During Treatment of Heart Failure With Mineralocorticoid Receptor Antagonists by Use of Sacubitril/Valsartan Compared With Enalapril: A Secondary Analysis of the PARADIGM-HF Trial[J]. JAMA Cardiol, 2017, 2(1): 79-85.
[71] Feng Y, Yin Y, Deng R, et al. Renal safety and efficacy of angiotensin receptor-neprilysin inhibitor: A meta-analysis of randomized controlled trials[J]. J Clin Pharm Ther, 2020, 45(6): 1235-1243.
[72] Generoso, Eloisa Trina Cesante, St. Luke's Medical Center - Global City, et al. Renal Outcomes of Sacubitril-Valsartan vs. ACE Inhibitors and Angiotensin Receptor Blockers in Heart Failure: A Systematic Review and Meta-Analysis. Presented at ASN Congress (2020). Available online at: https://www.asn-online.org/education/kidneyweek/2020/programabstract. aspx?controlId=3449363
[73] Pontremoli R, Borghi C, Filardi P P. Renal protection in chronic heart failure: focus on sacubitril/valsartan[J]. Eur Heart J Cardiovasc Pharmacother, 2021 ,21;7(5):445-452.
[74] Feng Z, Wang X, Zhang L, et al. Pharmacokinetics and pharmacodynamics of SacubitrilValsartan in maintenance hemodialysis patients with heart failure[J]. Blood Purif. (2022) 51:270–279.
[75] Lee S, Oh J, Kim H, et al. Sacubitril/valsartan in patients with heart failure with reduced ejection fraction with endstage of renal disease[J]. ESC Heart Fail. (2020) 7:1125–1129.
[76] Fu S, Xu Z, Lin B, et al. Effects of Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction in Patients Undergoing Peritoneal Dialysis[J]. Front Med (Lausanne), 2021, 8: 657067.
[77] Lin J, Ding XQ, Lin P, et al. A multi-center survey of hypertension and its treatment in patients with maintenance hemodialysis in Shanghai[J]. Zhonghua Nei Ke Za Zhi. (2010) 49:563–567.
[78] Zhang W, Shi W, Liu Z, et al. A nationwide cross-sectional survey on prevalence, management and pharmacoepidemiology patterns on hypertension in Chinese patients with chronic kidney disease[J]. Sci Rep, 2016, 6: 38768.
[79] Maruyama T, Takashima H, Abe M. Blood pressure targets and pharmacotherapy for hypertensive patients on hemodialysis[J]. Expert Opin Pharmacother, 2020, 21(10): 1219-1240.
[80] Lihua W C L, Chen H, Wei F, et al. Use of Angiotensin Receptor Neprilysin Inhibitor in Patients on Maintenance Hemodialysis with Reduced Cardiac Ejection Fraction, Real-World Experience From a Single Center. [J]. Iran J Kidney Dis., 2021, 15(4): 288-299.
[81] Judge P, Haynes R, Landray M J, et al. Neprilysin inhibition in chronic kidney disease[J]. Nephrol Dial Transplant, 2015, 30(5): 738-743.

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