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

EMPA-REG OUTCOME®是一项长期、国际、随机、双盲、安慰剂对照临床试验，入选了7,000多名来自42个国家确诊有心血管病的II型糖尿病患者。<\/p> \n

本研究评估了与在标准疗法基础上加用安慰剂的情况相比，在标准疗法基础上加用恩格列净（10 mg或25 mg每日一次）的疗效。标准疗法由降糖药物及心血管药物（包括降压药及调脂药）组成。主要终点定义为至首次发生心血管死亡、非致死性心脏病发作或非致死性卒中的时间。<\/p> \n

恩格列净在EMPA-REG OUTCOME®<\/sup>试验中的整体安全性特征与此前临床试验所观察到的结果一致。<\/p> \n

关于心力衰竭<\/b><\/p> \n

心力衰竭是心脏无法向身体泵出足量血液时发生的一种进展性、消耗性甚至可能会致死的疾病。[6]<\/sup><\/sup>心力衰竭的症状包括呼吸困难、浮肿、疲乏及其他症状。[7]<\/sup><\/sup>心力衰竭是一种流行病；在世界范围内，慢性心力衰竭的患者数已达到了2600万人。[8]<\/sup><\/sup>由于约有50%的确诊心力衰竭患者将会在五年内死亡，因此在对心力衰竭的治疗方面存在着很高的亟待满足的需求。[9]<\/sup><\/sup>此外，心力衰竭也是欧美65岁及以上人群中最常见的住院原因。10<\/sup>心力衰竭在糖尿病患者中发病率很高；[10]<\/sup><\/sup> 然而，在所有心衰患者中约有半数并未患有糖尿病。10<\/sup>,<\/sup>[11]<\/sup><\/sup><\/p> \n

关于慢性肾病<\/b><\/p> \n

慢性肾病定义为随时间推移肾功能进行性减退的疾病。 <\/p> \n

约有三分之二的慢性肾病可归因于糖尿病、肥胖及高血压等代谢性疾病。[12]<\/sup><\/sup>,<\/sup>[13]<\/sup><\/sup>,<\/sup>[14]<\/sup><\/sup><\/p> \n

值得注意的是，慢性肾病会增加患者的患病率及死亡率。慢性肾病患者主要的死亡原因为心血管并发症，并且通常都会在达到终末期肾病之前发生。[15]<\/sup><\/sup>,<\/sup>[16]<\/sup><\/sup>,<\/sup>[17]<\/sup><\/sup> 一旦进展为终末期肾病，则受累个体必须进行长期透析或肾移植等肾替代治疗。[18]<\/sup><\/sup>慢性肾病在世界各地都高发，患病人数超过了人口数量的10%[19]<\/sup><\/sup>。鉴于目前还没有疗法被批准专用于减缓肾病进展、降低心血管死亡率，在整体上慢性肾病患者对于新的疗法显然有着亟待满足的医疗需求。<\/p> \n

关于恩格列净<\/b>
<\/p> \n

恩格列净（商品名为欧唐静®<\/sup>）是一种每日一次口服给药的高选择性钠-葡萄糖转运体2（SGLT2）抑制剂，同时也是第一种在药品说明书上包括了可降低心血管死亡风险数据的II型糖尿病治疗药物。[20]<\/sup>,[21],[22]<\/sup><\/p> \n

恩格列净对于II型糖尿病患者SGLT2以及高血糖的抑制作用能够促使多余的糖分通过尿液排出体外。此外，启动恩格列净治疗能够增加体内盐分的排出并减少机体血管系统的体液负荷（即血管内容量）。恩格列净诱导体内糖、盐及水的代谢发生改变，这可能与EMPA-REG OUTCOME®<\/sup>试验中所观察到的心血管死亡率降低现象存在关联性。<\/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]);})();