2022-08-31 09:59:25來源：藥方舟瀏覽量：272
首個且目前唯一獲批用于治療癥狀性慢性心力衰竭成人患者（無論患者射血分數如何）的SGLT-2抑制劑歐唐靜在華獲批。
該適應癥的獲批基于 EMPEROR-Preserved Ⅲ 期臨床試驗。試驗表明，與安慰劑組相比，恩格列凈治療可使得射血分數保留的 成人心力衰竭患者心血管死亡或因心力衰竭住院的復合終點的發生風險顯著降低21%[1]，反復因心力衰竭住院的相對風險降低27%。已知的獲益與射血分數及糖尿病狀態無關[1]。
這是繼成人2型糖尿病和射血分數降低的成人心力衰竭之后，歐唐靜在中國獲批的第三個適應癥。
參考資料
[1]Stefan D. Anker, Javed Butler, Gerasimos Filippatos, et al. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. August 27, 2021. DOI: 10.1056/NEJMoa2107038.
[2]中國心力衰竭診斷和治療指南2018，中華醫學會心血管病學分會心力衰竭學組, 中國醫師協會心力衰竭專業委員會, 中華心血管病雜志編輯委員會.中華心血管病雜志, 2018,46(10) : 760-789. DOI: 10.3760/cma.j.issn.0253-3758.2018.10.004
[3]GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Lancet 2017;390:1211; 2.;
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[5]Metra M, Lucioli P. Corrigendum to ‘Prevalence of heart failure and left ventricular dysfunction in China: the China Hypertension Survey, 2012-2015’ [Eur J Heart Fail, 2019, 21 (11): 1329-1337. ][J]. Eur J Heart Fail, 2020, 22 (4): 759. DOI: 10. 1002/ejhf. 1808.
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[9]REPRESENT-HF study. Data on file.
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[11]中國心血管健康與疾病報告編寫組.中國心血管健康與疾病報告2019概要[J].中國循環雜志,2020,35(9):833-854.
[12]Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;128(16):e240–e327.
[13]Suskin N, McKelvie RS, Burns RJ, et al. Glucose and insulin abnormalities relate to functional capacity in patients with congestive heart failure. Eur Heart J. 2000;21:1368–75.
[14]GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: A systematic analysis for the Global Burden of Disease Study 2015. The Lancet. 2016; 388(10053):1459–544.
[15]Jardiance? (empagliflozin) tablets, U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed: June 2021.
[16]Jardiance? (empagliflozin) tablets. European Product Information; approved April 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/jardiance-epar-product-information_en.pdf. Accessed June 2021.
[17]Jardiance?(Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.
[18]Packer M, Anker SD, Butler J, et al. Cardiac and Renal Outcomes With Empagliflozin in Heart Failure With a Reduced Ejection Fraction. N Engl J Med. 2020-The Digital Experience
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