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關于<\/b>EMPEROR<\/b>心力衰竭研究<\/b>[15],[16] <\/p> \n
EMPEROR(采用恩格列凈治療慢性心衰患者的結局試驗)慢性心衰研究包括兩項III期、隨機、雙盲試驗,針對射血分數降低與射血分數保留的成人慢性心衰患者(均包括伴與不伴糖尿病的患者),在接受標準治療的基礎上,研究每日一次恩格列凈與安慰劑相比的療效與安全性:<\/p> \n
關于<\/b>EMPOWER<\/b>項目<\/b><\/p> \n
聯盟開發了EMPOWER項目,旨在探索恩格列凈對一系列心臟-腎臟-代謝疾病的主要臨床心血管和腎臟結局的影響。心腎代謝疾病是全球死亡的主要原因,每年導致的死亡病例高達2000萬。[17]通過EMPOWER項目,勃林格殷格翰和禮來正在努力增加對這些相關系統的認知,并開發可提供綜合、多器官獲益的治療。EMPOWER由9項臨床試驗和兩項真實世界研究組成,EMPEROR強化了聯盟對改善心臟-腎臟-代謝疾病患者臨床治療結局的長期承諾。臨床研究全球入組超過400,000位成人患者,EMPOWER是迄今為止針對SGLT2抑制劑開展的最廣泛和最全面的臨床項目之一。<\/p> \n
關于心力衰竭<\/b><\/p> \n
心力衰竭是一種進行性加重、導致虛弱并可能危及生命的疾病,當心臟不能供應足夠的血液循環以滿足身體對含氧血液的需求或需要增加血容量導致肺部和外周組織液體積聚(充血)時發生。[18],<\/sup>[19]心力衰竭是一種常見的疾病,累及全球6000萬人,[3,4] 其發病率預計會隨著人口老齡化而增加。心力衰竭在糖尿病患者中非常普遍 ,[20] 然而大約一半的心力衰竭患者不伴有糖尿病。[21]<\/p> \n 心力衰竭有不同的類型。患者可以伴有左側射血分數降低或保留的心力衰竭。射血分數是測量每次左心室收縮時泵出的血液百分比。[22]當心臟舒張時,心室重新充滿血液。<\/p> \n 心力衰竭患者經常會出現呼吸困難和疲勞,這會嚴重影響他們的生活質量。[23]患有心力衰竭的患者通常也有腎功能受損,這會對預后產生顯著的負面影響。[24]<\/p> \n 關于心臟<\/b>-<\/b>腎臟<\/b>-<\/b>代謝疾病<\/b> 勃林格殷格翰和禮來希望能改變心臟-腎臟-代謝疾病患者的治療方式,這是一組相互關聯的疾病,影響全球超過10億人,是死亡的主要原因。[4,17]<\/p> \n 心血管、腎臟和代謝系統相互關聯,在疾病譜中具有許多相同的風險因素和病理途徑。一個系統的功能障礙可能會加速其它系統的發病,從而導致相關疾病的發展,如2型糖尿病、心血管疾病、心力衰竭和腎臟疾病等相互關聯的疾病,進而導致心血管死亡風險增加。相反,一個系統的改善可以在其它系統中產生積極的影響。[25],[26],[27]<\/p> \n 通過我們的研究和治療,我們的目標是支持患者的健康,恢復相互關聯的心臟-腎臟-代謝系統之間的平衡,并降低他們發生嚴重并發癥的風險。作為對那些健康受到心臟-腎臟-代謝疾病危害患者承諾的一部分,我們將繼續研究多學科治療方案,并將我們的資源集中在填補治療空白上。<\/p> \n 關于恩格列凈<\/b><\/p> \n 恩格列凈(商品名為歐唐靜® )是一種口服、每日一次、高選擇性鈉-葡萄糖協同轉運蛋白2(SGLT2)抑制劑,也是首個在諸多國家的說明書中包含降低心血管死亡風險數據的2型糖尿病藥物。[9,10,11]<\/p> \n 關于勃林格殷格翰和禮來<\/b><\/p> \n 2011年1月,勃林格殷格翰公司和禮來制藥宣布達成合作協議,合作內容包括數類降糖藥物的多個品種。基于不同的市場,雙方將選擇共同推廣或單獨推廣各自為此項合作所提供的藥物。這項合作整合了兩大專注于患者需求的全球領先制藥公司的實力,通過攜手合作,兩家公司承諾致力于幫助糖尿病患者,并探索解決患者未滿足的醫療需求。評估恩格列凈對心力衰竭或慢性腎臟疾病患者影響的臨床試驗已經啟動。<\/p> \n 關于勃林格殷格翰<\/b><\/p> \n 勃林格殷格翰致力于研究突破性療法,旨在改善人類和動物的健康。作為一家研發驅動的全球領先生物制藥企業,公司在醫療需求高度未得到滿足的領域通過創新展現價值。自1885年成立以來,勃林格殷格翰始終是一家獨立的家族企業,從長遠來看這一點將不會改變。在人用藥品、動物保健和生物制藥合同生產三大業務領域,全球有約5.2萬名員工服務逾130個地區。更多詳情,請訪問:www.boehringer-ingelheim.com<\/a><\/p> \n 關于禮來公司<\/b> 作為全球醫療健康產業領導者,禮來致力于以創新回報患者、以關愛呵護生命。創立一百四十余年來,禮來始終奉行著以最新技術為患者提供最優質藥品的理念,這與公司創始人禮來上校的承諾一脈相承。今天,禮來仍然執著于這一使命,并據此開展各項工作。世界各國的禮來人不僅潛心研發挽救生命的藥品、積極幫助患者更好地認識和管理疾病,還通過慈善公益活動全心回饋社會。欲了解更多關于禮來制藥的信息,請登錄 http:\/\/www.lilly.com<\/a> 和https:\/\/newsroom.lilly.com\/social-channels<\/a>.<\/p> \n CONTACTS:<\/b><\/p> \n Stefanie Molkenthin<\/span><\/b> Anna Bergmann<\/span> References<\/b><\/p> \n [1] Anker S, Butler J, Filippatos G, et al<\/i>. Empagliflozin in Heart Failure With a Preserved Ejection Fraction. N Engl J Med<\/i>. 2021;[insert]. <\/p> \n [2] Anker S. EMPEROR-Preserved: effect of empagliflozin on cardiovascular death and heart failure hospitalisations in patients with heart failure with a preserved ejection fraction, with and without diabetes. Presented on 27 August 2021<\/span> at the European Society of Cardiology (ESC) Congress 2021 – The Digital Experience.<\/p> \n [3] Andersen MJ, Borlaug BA. Heart failure with preserved ejection fraction: current understandings and challenges. Curr Cardiol Rep<\/i>. 2014;16(7):501.<\/p> \n [4] GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet.<\/i> 2018;392(10159):1789–858.<\/p> \n [5] Butler J, Fonarow G, Zile M, et al<\/i>. Developing therapies for heart failure with preserved ejection fraction: Current State and Future Directions. JACC Heart Fail<\/i>. 2014 Apr;2(2):97–112.<\/p> \n [6] Shah SJ, Borlaug B, Kitzman D, et al<\/i>. Research priorities for heart failure with preserved ejection fraction. Circulation<\/i>. 2020;141:1001–26.<\/p> \n [7] Boehringer Ingelheim. Data on file.<\/p> \n [8] Packer M, Anker SD, Butler J, et al<\/i>. Cardiac and Renal Outcomes With Empagliflozin in Heart Failure With a Reduced Ejection Fraction. N Engl J Med.<\/i> 2020;383:1413–24.<\/p> \n [9] Jardiance® (empagliflozin) tablets. European Product Information, approved April 2020<\/span>. Available at: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/jardiance-epar-product-information_en.pdf<\/a>. Accessed August 2021<\/span>.<\/p> \n [10] Jardiance®<\/sup> (empagliflozin) tablets, U.S. Prescribing Information. Available at: http:\/\/docs.boehringer-ingelheim.com\/Prescribing%20Information\/PIs\/Jardiance\/jardiance.pdf<\/a>. Accessed: August 2021<\/span>.<\/p> \n [11] Jardiance®<\/sup> (Full Prescribing Information). Mexico<\/span>; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.<\/p> \n [12] [PDUFA announcement].<\/p> \n [13] ClinicalTrials.gov. EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction). Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04509674<\/a>. Accessed: August 2021<\/span>.<\/p> \n [14] ClinicalTrials.gov. EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin). Available at: https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT03594110<\/a>. Accessed: August 2021<\/span>.<\/p> \n [15] ClinicalTrials.gov. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced). Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03057977<\/a>. Accessed: August 2021<\/span>.<\/p> \n [16] ClinicalTrials.gov. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved). Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03057951<\/a>. Accessed: August 2021<\/span>.<\/p> \n [17] 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. Lancet<\/i>. 2016; 388(10053):1459–544.<\/p> \n [18] American Heart Association. What is Heart Failure? Available at: https:\/\/www.heart.org\/en\/health-topics\/heart-failure\/what-is-heart-failure<\/a>. Accessed: August 2021<\/span>.<\/p> \n [19] American Heart Association. Types of Heart Failure. Available at: https:\/\/www.heart.org\/en\/health-topics\/heart-failure\/what-is-heart-failure\/types-of-heart-failure<\/a>. Accessed: August 2021<\/span>.<\/p> \n [20] Kenny HC, Abel ED. Heart Failure in Type 2 Diabetes Mellitus. Circ Res. <\/i>2019;124(1):121–41.<\/p> \n [21] Dunlay SM, Givertz MM, Aguilar D, et al.<\/i> Type 2 Diabetes Mellitus and Heart Failure: A Scientific Statement From the American Heart Association and the Heart Failure Society of America. Circulation.<\/i> 2019;140:e294–e324.<\/p> \n [22] American Heart Association. Ejection Fraction Heart Failure Measurement. Available at: https:\/\/www.heart.org\/en\/health-topics\/heart-failure\/diagnosing-heart-failure\/ejection-fraction-heart-failure-measurement<\/a>. Accessed: August 2021<\/span>.<\/p> \n [23] Calvert MJ, Freemantle N, Cleland JGF. The impact of chronic heart failure on health–related quality of life data acquired in the baseline phase of the CARE–HF study. Eur J Heart Fail<\/i>. 2005;7(2):243–51.<\/p> \n [24] Sarnak MJ. A patient with heart failure and worsening kidney function. Clin J Am Soc Nephrol<\/i>. 2014;9(10):1790–98.<\/p> \n [25] García-Donaire JA, Ruilope LM. Cardiovascular and Renal Links along the Cardiorenal Continuum. Int J Nephrol<\/i>. 2011;2011:975782.<\/p> \n [26] Leon BM, Maddox TM. Diabetes and cardiovascular disease: Epidemiology, biological mechanisms, treatment recommendations and future research. World J Diabetes<\/i>. 2015;6(13):1246–58.<\/p> \n [27] <\/sup>Thomas M, Cooper M, Zimmet P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. Nat Rev Nephrol. <\/i>2015;12:73–81.<\/p>"];
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Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com<\/a>
Phone: +49 (6132) 77 172 209<\/p> \n
<\/b>Global Business Communications
Eli Lilly and Company
Email: anna.bergmann@lilly.com<\/a>
Phone: +1 317 864 3143<\/p> \n