恩格列净大幅降低心衰患者心血管死亡及因心衰而住院的风险

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恩格列净大幅降低心衰患者心血管死亡及因心衰而住院的风险 。
恩格列净:恩格列净片多少钱。恩格列净大幅降低心衰患者心血管死亡及因心衰而住院的风险本文重点:-恩格列净将首次和再次因心衰而住院的相对危险大幅减少30%,同时显著减缓肾脏功能的下降-伴和不伴2型糖尿病患病者亚组的结果均一致1-心力衰竭是美国和欧洲患病者住院的主要原理 2-III期EMPEROR-Reduced临床实验结果今日发表于《新英格兰医科学杂志》1
近日,勃林格殷格翰和礼来公司公布了III期 EMPEROR-Reduced临床实验的完整结果,这项研究针对伴和不伴糖尿病、射血分数减少的心力衰竭成人患病者。研究结果表明:恩格列净可将心血管去世(过滤词)或因心衰而住院的相对危险(试验主要终点)显著减少25%。1这项试验评估了在标准治疗基础上加用恩格列净(10 毫克)与加用安慰剂相比的疗效。1 研究结果在2022年欧洲心脏病学会(ESC)年会上对外公布,[i]并发表在《新英格兰医科学杂志》上。主要终点结果在伴和不伴2型糖尿病的患病者亚组中均保持一致。1试验的关键次要终点分析表明:恩格列净可将首次和再次因心衰而住院的相对危险减少30%。1此外,与安慰剂组相比,恩格列净组患病者的eGFR(衡量肾功能下降的指标)下降更慢。1
心力衰竭影响全球超过6000万人, 美国和欧洲每年因心衰而住院的人数超过100万。2 发生心力衰竭时,心脏无法将足够的血液泵送到身体其余部位,它是心肌梗塞最常见且严重的一并发生的不良症状。5,6心衰患病者经常会感到呼吸困难和疲劳,这严重影响他们的生活质量。 7,8心衰患病者的肾功能通常也会受损,这可能对预后产生重大负面影响。 9勃林格殷格翰公司副总裁、心脏代谢领域医科学负责人Waheed Jamal博士表示:“心力衰竭会对患病者产生深远的影响,可能会带来严重影响患病者生活的心脏和肾脏后果。EMPA-REGOUTCOME®试验结果表明,针对2型糖尿病合并确诊的心血管疾病患病者,恩格列净是首个可减少心血管去世与因心衰而住院危险的SGLT2抑制剂。随着EMPEROR-Reduced试验结果的公布,我们开创了全新的局面。如今我们有强大的证据表明,恩格列净可减少心血管疾病危险并减缓心衰患病者的肾脏损害进展,从而改变数百万患病者的生活。我们期待进一步探索这些数据,并计划在今年晚些时候向监管机构提交注册申请。”礼来公司产品开发副总裁Jeff Emmick博士表示:“数以千万计的人患有心力衰竭和肾脏疾病,其中许多患病者伴有糖尿病。EMPEROR-Reduced试验结果表明,恩格列净可帮助改善心力衰竭的治疗结果,同时减缓患病者肾功能的下降。 我们很高兴分享这些数据。通过正在进行的EMPOWER计划,我们希望重新定义这些患病者的治疗方法。”中国医科学科学院阜外医院张健教授表示:“中国心力衰竭患病者人数已逾千万,给患病者家庭和社会造成了严重的负担。EMPEROR-Reduced试验结果表明,无论是否合并糖尿病,慢性射血分数减低的心力衰竭(HFrEF) 患病者在标准治疗基础上应用SGLT2抑制剂恩格列净治疗均能显著减少心血管和肾脏(过滤词)的危险。我们期待着未来这一突破性的药物能给中国的心力衰竭患病者带去新的治疗选择。”
关于EMPEROR心力衰竭研究11, 16EMPEROR(采用恩格列净治疗慢性心衰患病者的结局试验)慢性心衰研究包括两项III期、随机、双盲试验,针对射血分数保留与射血分数减少的成人慢性心衰患病者(均包括伴与不伴糖尿病的患病者),在接受标准治疗的基础上,研究每天一次恩格列净与安慰剂相比的治疗效果与安全特性。关于恩格列净大幅降低心衰患者心血管死亡及因心衰而住院的风险EMPOWER项目联盟开发了EMPOWER项目,旨在探索恩格列净对一系列心脏-肾脏-代谢疾病的主要临床心血管和肾脏结局的影响。心肾代谢疾病是全球去世的主要原理,每年导致的去世病例达到2000万。 17 通过EMPOWER项目,勃林格殷格翰和礼来正在努力增加对这些互联系统的认知,并开发可提供综合、多器官获益的治疗。10关于恩格列净恩格列净(商品名为欧唐静® )是一种口服、每天一次、高选择性钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂,也是首个在诸多国家的说明书中包含减少心血管去世危险数据的2型糖尿病药物。23,24,25恩格列净在中国批准适用于治疗2型糖尿病,配合餐饮运动控制,能够单药、联合二甲双胍或联合二甲双胍和磺脲类药物治疗改善2型糖尿病患病者的血糖控制。26,27,28 EMPA-REG OUTCOME® 试验数据显示,恩格列净可诱导体内糖、盐、水代谢的变化,进而减少2型糖尿病合恩格列净大幅降低心衰患者心血管死亡及因心衰而住院的风险并心血管疾病患病者心血管去世危险。关于勃林格殷格翰和礼来2011年1月,勃林格殷格翰公司和礼来制药宣布达成合作协议,合作内容包括数类降糖药物的多个品种。基于不同的市场,双方将选择共同推广或单独推广各自为此项合作所提供的药物。这项合作整合了两大专注于患病者需求的全球领先制药公司的实力,通过携手合作,两家公司承诺致力于帮助糖尿病患病者,并探索解决患病者未满足的医疗需求。已经启动临床实验,评估欧唐静®对心力衰竭或慢性肾脏疾病患病者的影响。


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