德國殷格翰與美國印第安納波利斯2018年7月3日電 /美通社/ -- 勃林格殷格翰與禮來公司（NYSE：LLY）今天宣布，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）就更新歐唐靜®（恩格列凈）、Synjardy®（恩格列凈+二甲雙胍）及Glyxambi®（恩格列凈+利格列汀）藥品說明書并收錄來自具有里程碑意義的EMPA-REG OUTCOME®試驗在心力衰竭及腎功能終點方面的其他重要數(shù)據(jù)表示了支持意見。1,[1]
現(xiàn)在的藥品說明書收錄了來自EMPA-REG OUTCOME®試驗的其他結(jié)果，表述為：在2型糖尿病合并心血管疾病的患者中，相較于安慰劑，恩格列凈可使患者因心衰住院的相對風險降低35%，新發(fā)腎病或腎病惡化的相對風險降低39%。1,2
“心力衰竭及腎病在II型糖尿病患者中發(fā)病率很高，并且具有較高的致殘率及致死率，”勃林格殷格翰副總裁、心臟代謝醫(yī)學(xué)部負責人Waheed Jamal博士說。“由于在此類病癥的治療方面存在著亟待滿足的臨床需求，我們對歐洲藥品管理局認可恩格列凈在降低II型糖尿病合并心血管疾病患者的心力衰竭及腎病風險方面具有明確獲益表示歡迎?！?/p>
“在EMPA-REG OUTCOME®試驗中，恩格列凈在降低II型糖尿病合并確診心血管疾病患者的心血管死亡風險方面表現(xiàn)出了優(yōu)效性，”禮來糖尿病產(chǎn)品開發(fā)部副總裁Jeff Emmick, M.D., Ph.D.說?！耙虼耍鞲窳袃羰堑谝环N在藥品說明書上具有心血管適應(yīng)癥或者降低心血管死亡風險數(shù)據(jù)的II型糖尿病治療藥物?！?/p>
以EMPA-REG OUTCOME®試驗結(jié)果為基礎(chǔ)，勃林格殷格翰與禮來公司目前正在伴有或不伴有糖尿病的心力衰竭（EMPEROR、EMPERIAL臨床試驗）及慢性腎?。‥MPA-KIDNEY臨床試驗）人群中對恩格列凈進行進一步研究。[2],[3],[4],[5]
关于EMPA-REG OUTCOME®2,3
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。
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。
恩格列净在EMPA-REG OUTCOME®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。
关于心力衰竭
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]心力衰竭的症状包括呼吸困难、浮肿、疲乏及其他症状。[7]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]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]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心力衰竭在糖尿病患者中发病率很高；[10] 然而，在所有心衰患者中约有半数并未患有糖尿病。10,[11]
关于慢性肾病
慢性肾病定义为随时间推移肾功能进行性减退的疾病。
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],[13],[14]
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],[16],[17] 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]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]。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。
关于恩格列净
恩格列净（商品名为欧唐静®）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],[21],[22]
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®试验中所观察到的心血管死亡率降低现象存在关联性。
References
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[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 .Last accessed: May 2018.
[6] 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. Last accessed May 2018.
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[14] United States Renal Data System, USRDS 2012 Annual data report: Atlas of chronic kidney disease and end-stage renal disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012.Available from: http://www.usrds.org/reference.htm.See Appendix I, United States Renal Data System (USRDS).
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[18] American Kidney Fund.Kidney Failure (ESRD) Causes, Symptos, & Treatments.Available at: http://www.kidneyfund.org/kidney-disease/kidney-failure/. Accessed March 2018.
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