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關于EMPA-REG OUTCOME®<\/sup><\/b>2<\/sup><\/b>,<\/sup><\/b>3<\/sup><\/b> <\/p> \n

EMPA-REG OUTCOME®是一項長期、國際、隨機、雙盲、安慰劑對照臨床試驗，入選了7,000多名來自42個國家確診有心血管病的II型糖尿病患者。<\/p> \n

本研究評估了與在標準療法基礎上加用安慰劑的情況相比，在標準療法基礎上加用恩格列凈（10 mg或25 mg每日一次）的療效。標準療法由降糖藥物及心血管藥物（包括降壓藥及調脂藥）組成。主要終點定義為至首次發生心血管死亡、非致死性心臟病發作或非致死性卒中的時間。<\/p> \n

恩格列凈在EMPA-REG OUTCOME®<\/sup>試驗中的整體安全性特征與此前臨床試驗所觀察到的結果一致。<\/p> \n

關于心力衰竭<\/b><\/p> \n

心力衰竭是心臟無法向身體泵出足量血液時發生的一種進展性、消耗性甚至可能會致死的疾病。[6]<\/sup><\/sup>心力衰竭的癥狀包括呼吸困難、浮腫、疲乏及其他癥狀。[7]<\/sup><\/sup>心力衰竭是一種流行病；在世界范圍內，慢性心力衰竭的患者數已達到了2600萬人。[8]<\/sup><\/sup>由于約有50%的確診心力衰竭患者將會在五年內死亡，因此在對心力衰竭的治療方面存在著很高的亟待滿足的需求。[9]<\/sup><\/sup>此外，心力衰竭也是歐美65歲及以上人群中最常見的住院原因。10<\/sup>心力衰竭在糖尿病患者中發病率很高；[10]<\/sup><\/sup> 然而，在所有心衰患者中約有半數并未患有糖尿病。10<\/sup>,<\/sup>[11]<\/sup><\/sup><\/p> \n

關于慢性腎病<\/b><\/p> \n

慢性腎病定義為隨時間推移腎功能進行性減退的疾病。 <\/p> \n

約有三分之二的慢性腎病可歸因于糖尿病、肥胖及高血壓等代謝性疾病。[12]<\/sup><\/sup>,<\/sup>[13]<\/sup><\/sup>,<\/sup>[14]<\/sup><\/sup><\/p> \n

值得注意的是，慢性腎病會增加患者的患病率及死亡率。慢性腎病患者主要的死亡原因為心血管并發癥，并且通常都會在達到終末期腎病之前發生。[15]<\/sup><\/sup>,<\/sup>[16]<\/sup><\/sup>,<\/sup>[17]<\/sup><\/sup> 一旦進展為終末期腎病，則受累個體必須進行長期透析或腎移植等腎替代治療。[18]<\/sup><\/sup>慢性腎病在世界各地都高發，患病人數超過了人口數量的10%[19]<\/sup><\/sup>。鑒于目前還沒有療法被批準專用于減緩腎病進展、降低心血管死亡率，在整體上慢性腎病患者對于新的療法顯然有著亟待滿足的醫療需求。<\/p> \n

關于恩格列凈<\/b>
<\/p> \n

恩格列凈（商品名為歐唐靜®<\/sup>）是一種每日一次口服給藥的高選擇性鈉-葡萄糖轉運體2（SGLT2）抑制劑，同時也是第一種在藥品說明書上包括了可降低心血管死亡風險數據的II型糖尿病治療藥物。[20]<\/sup>,[21],[22]<\/sup><\/p> \n

恩格列凈對于II型糖尿病患者SGLT2以及高血糖的抑制作用能夠促使多余的糖分通過尿液排出體外。此外，啟動恩格列凈治療能夠增加體內鹽分的排出并減少機體血管系統的體液負荷（即血管內容量）。恩格列凈誘導體內糖、鹽及水的代謝發生改變，這可能與EMPA-REG OUTCOME®<\/sup>試驗中所觀察到的心血管死亡率降低現象存在關聯性。<\/p> \n

References<\/b><\/p> \n

[1] <\/sup><\/sup>Jardiance®<\/sup> (empagliflozin) Summary of Product Characteristics. EMA. Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/002677\/WC500168592.pdf<\/a>. Last accessed June 2018<\/span>.<\/p> \n

[2] EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved).Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03057951?term=emperor&rank=2<\/a>. Last accessed: May 2018<\/span>.<\/p> \n

[3] EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced).Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03057977?term=emperor&rank=1.Last<\/a> accessed: May 2018<\/span>.<\/p> \n

[4] A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF) (EMPERIAL – preserved).Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03448406?term=EMPERIAL&rank=1<\/a>. Last accessed: May 2018<\/span>.<\/p> \n

[5] A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection Fraction (HFrEF) (EMPERIAL – reduced).Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03448419?term=EMPERIAL&rank=2<\/a> .Last accessed: May 2018<\/span>.<\/p> \n

[6]<\/sup><\/sup> American Heart Association.What is Heart Failure? Available at: http:\/\/www.heart.org\/HEARTORG\/Conditions\/HeartFailure\/AboutHeartFailure\/What-is-Heart-Failure_UCM_002044_Article.jsp#.WleEeLSFjBI<\/a>. Last accessed May 2018<\/span>.<\/p> \n

[7] <\/sup><\/sup>Watson RDS, Gibbs CR, Lip GYH.Clinical features and complications.British Medical Journal.2000;320(7229):236-239.<\/p> \n

[8]<\/span><\/sup> Ambrosy A.P., et al.The Global Health and Economic Burden of Hospitalizations for Heart Failure.J Am Coll Cardiol 2014.1;63(12):1123-1133.<\/p> \n

[9]<\/sup><\/sup>Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, et al.Heart disease and stroke statistics—2013 update: a report from the American Heart Association.Circulation.2013;127:e6–e245<\/p> \n

[10]<\/sup><\/sup> Yancy CW., 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 62 (16), e147 - e239.<\/p> \n

[11]<\/sup><\/sup> Suskin N, et al.Glucose and insulin abnormalities relate to functional capacity in patients with congestive heart failure.Eur Heart J 2000;21:1368-75.<\/p> \n

[12] <\/sup><\/sup>Levin A, Tonelli M, Bonventre J, et al.Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy.Lancet 2017;390:1888-917.<\/p> \n

[13] <\/sup><\/sup>Liyanage T, Ninomiya T, Jha V, et al.Worldwide access to treatment for end-stage kidney disease: a systematic review.Lancet 2015; 385(9981):1975-82.<\/p> \n

[14]<\/sup> United States Renal Data System, USRDS 2012 Annual data report: Atlas of chronic kidney disease and end-stage renal disease in the United States<\/span>, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD<\/span>, 2012.Available from: http:\/\/www.usrds.org\/reference.htm.See<\/a> Appendix I, United States Renal Data System (USRDS).<\/p> \n

[15] <\/sup><\/sup>Sarnak MJ, Levey AS, Schoolwerth AC, et al.Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention.Hypertension 2003;42:1050-65. <\/p> \n

[16] <\/sup><\/sup>Tonelli M, Wiebe N, Culleton B, et al.Chronic kidney disease and mortality risk: a systematic review.J Am Soc Nephrol.2006;17:2034-47. <\/p> \n

[17] <\/sup><\/sup>Schiffrin EL, Lipman ML and Mann JFE.Chronic kidney disease: effects on the cardiovascular system.Circulation.2007;116:85-97. <\/p> \n

[18]<\/span><\/sup> American Kidney Fund.Kidney Failure (ESRD) Causes, Symptos, & Treatments.Available at: http:\/\/www.kidneyfund.org\/kidney-disease\/kidney-failure\/<\/a>. Accessed March 2018<\/span>.<\/p> \n

[19]<\/sup><\/sup> Eckardt K-U, Coresh J, Devuyst O, et al.Evolving importance of kidney disease: from subspecialty to global health burden.Lancet 2013;382:158-69.<\/p> \n

[20]<\/sup><\/sup> Jardiance®<\/sup> (empagliflozin) tablets U.S. Prescribing Information.Available at: http:\/\/docs.boehringer-ingelheim.com\/Prescribing%20Information\/PIs\/Jardiance\/jardiance.pdf<\/a>. Accessed May 2018<\/span>.<\/p> \n

[21] <\/sup><\/sup>European Summary of Product Characteristics Jardiance®, approved January 19<\/span>, 2017.Data on file. <\/p> \n

[22] <\/sup><\/sup>Jardiance®<\/sup> (Full Prescribing Information).Mexico<\/span>; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.<\/p>"]; $("#dvExtra").html(content_array[0]);})();

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