2020年11月5日07:05 GMT
Forxiga is the first SGLT2 inhibitor approved in the EU for 心 failure
with reduced ejection fraction in adult patients with and without type-2 diabetes
澳门在线赌城娱乐公司 Forxiga (dapagliflozin)已被欧盟(EU)批准用于治疗伴有或不伴有2型糖尿病(T2D)的有症状慢性心力衰竭伴射血分数降低(HFrEF)。.
心力衰竭(HF)是一种危及生命的慢性疾病，它会阻止心脏向全身泵送足够水平的血液. It affects 15 million people in the EU, at least half of whom have a reduced ejection fraction,1-3 当左心室肌肉不能充分收缩，从而向体内排出的富氧血液减少时，会发生什么.4-6
欧盟委员会的批准是基于具有里程碑意义的DAPA-HF III期试验的积极结果, 发表在 新英格兰医学杂志.7 它遵循 建议批准 by the Committee for Medicinal Products for Human Use of the European 药物 Agency.
约翰McMurray, MD, 心血管研究中心, Institute of 心血管 and Medical Sciences, 格拉斯哥大学, UK, 他说:“今天的批准为医生提供了一种全新的治疗心力衰竭的方法，可以降低射血分数, not only improving symptoms and reducing hospital admissions, but also increasing survival in this life-threatening condition.”
Mene Pangalos, Executive Vice President, 澳门第一赌城在线娱乐 R&D，说:“有了这个批准 Forxiga, we can redefine the standard of care for millions of people in the EU living with 心 failure. 通过提供一种可以显著减少心血管死亡和住院治疗的治疗方法，澳门第一赌城在线娱乐离实现预防或治疗心力衰竭的目标又近了一步.”
Forxiga 是否第一个钠-葡萄糖共转运蛋白-2 (SGLT2)抑制剂在心血管(CV)死亡或心衰事件恶化的复合风险方面显示出统计学上显著的降低, 包括因心衰住院(hHF). The DAPA-HF Phase III trial demonstrated that Forxiga, 除了标准护理之外, 与安慰剂相比，复合结局的风险降低了26%，主要复合终点的两个组成部分都对总体效果有益. In the DAPA-HF Phase III trial, the safety profile of Forxiga was consistent with the well-established safety profile of the medicine. 审判期间, one CV death or hHF or an urgent visit associated with HF could be avoided for every 21 patients treated.
Forxiga (被称为 Farxiga 在美国，该药物已被批准用于治疗HFrEF患者，目前正在日本和世界上多个国家接受审查.
Forxiga is advancing cardiorenal prevention as science continues to identify the underlying links between the 心, 肾脏和胰腺. DAPA-HF是DapaCare的一部分, a robust clinical trial programme to assess the potential CV and renal benefits of Forxiga. 该项目还在开创性的DAPA-CKD III期试验中探索了慢性肾脏疾病(CKD)患者的治疗. 此外, Forxiga 目前正在DELIVER III期试验中对保留射血分数(HFpEF)的HF患者进行测试，预计将于2021年下半年获得数据.
心脏衰竭
全世界约有6400万人患有心力衰竭(其中至少一半患者有射血分数降低)。, including 15 million in the EU and six million in the US.2-3,8 It is a chronic disease w在这里 half of patients will die within five years of diagnosis.9 T在这里 are two main categories of HF related to ejection fraction (EF), a measurement of the percentage of blood leaving the 心 each time it contracts: HFrEF and HFpEF.7 HFrEF occurs when the left ventricle muscle is not able to contract adequately and t在这里fore, expels less oxygen-rich blood in to the body.5,6 在男性(前列腺癌和膀胱癌)和女性(乳腺癌)中，心衰仍然和一些最常见的癌症一样致命。.10 它是65岁以上老人住院的主要原因，是一个重大的临床和经济负担.11
DAPA-HF
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is an international, 的多中心, 与这些相应平行的组织, 随机, 双盲III期临床试验4年,744 patients with 心 failure and reduced ejection fraction (LVEF ≤ 40%), 不论有无T2D, 评价的:用来评价…的效果的 Forxiga 10mg, compared with placebo, given once daily 除了标准护理之外. The primary composite endpoint was time to the first occurrence of a worsening 心 failure event (hospitalisation or equivalent event; i.e. an urgent 心 failure visit), or cardiovascular death. The median duration of follow-up was 18.2个月.
Forxiga
Forxiga (达格列净)是一流的, 口服, 每日一次的SGLT2抑制剂适用于成人治疗控制不足的T2D，可作为单一治疗和联合治疗的一部分，作为饮食和运动的辅助治疗，以改善血糖控制, with the additional benefits of weight loss and blood-pressure reduction.
Forxiga has been evaluated in patients with CKD in the Phase III DAPA-CKD trial, 随着全部结果的公布 2020年8月 证明 Forxiga met all primary and secondary endpoints, providing overwhelming efficacy. Forxiga is currently being tested for patients with HF in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) Phase III trials. Forxiga 在DAPA-MI试验中，也将在急性心肌梗死(MI)或心脏病发作后无T2D的患者中进行测试，这是同类试验的首例, indication-seeking, registry-based 随机 controlled trial. Forxiga 拥有强大的临床试验计划，包括超过35项已完成和正在进行的IIb/III期试验,000名患者, 以及超过2个.500万病人年的经验.
澳门在线赌城娱乐在crvrm
心血管, 肾脏和代谢(CVRM)共同构成澳门在线赌城娱乐的三大治疗领域之一，是公司的关键增长动力. By following the science to understand more clearly the underlying links between the 心, 肾脏和胰腺, 澳门在线赌城娱乐正在投资一系列药物，以保护器官，并通过减缓疾病进展来改善结果, reducing risks and tackling comorbidities. 该公司的目标是改变或停止crvrm疾病的自然过程，并可能使器官再生和恢复功能, 通过继续提供变革性的科学，改善全球数百万患者的治疗实践和心血管健康.
澳门在线赌城娱乐
澳门在线赌城娱乐 (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - 肿瘤学, 心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门在线赌城娱乐在100多个国家开展业务，其创新药物被全球数百万患者使用. 请访问 澳门在线赌城娱乐.com 并在推特上关注公司 @澳门在线赌城娱乐.
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参考文献
1. 梅奥诊所. 心脏衰竭; 29 May 2020 [cited 21 October 2020]. 可从:URL: http://www.mayoclinic.org/diseases-conditions/心-failure/symptoms-causes/syc-20373142.
2. 迪克斯坦K等人. ESC急性和慢性心力衰竭诊断和治疗指南2008:欧洲心脏病学会急性和慢性心力衰竭诊断和治疗工作组2008. 与ESC心力衰竭协会(HFA)合作开发，并得到欧洲重症监护医学协会(ESICM)的认可。. 欧洲心脏 2008; 29:2388-2442.
3. Travessa AMR, Menezes falc
4. 美国心脏协会. Ejection Fraction Heart Failure Measurement; 2017 [cited 2 Nov 2020]. 可从:网址: http://www.心.org/en/health-topics/心-failure/diagnosing-心-failure/ejection-fraction-心-failure-measurement.
5. Ponikowski等. 2016 ESC急性和慢性心力衰竭诊断和治疗指南:欧洲心脏病学会(ESC)急性和慢性心力衰竭诊断和治疗工作组在ESC心力衰竭协会(HFA)的特殊贡献下制定. 欧洲心脏 2016; 37(27):2129–200.).
6. 国家指南中心(英国). Chronic Heart Failure in Adults: Diagnosis and Management. London: National Institute for Health and Care Excellence (UK); 2018 Sep. (NICE指南，No. 106.13、词汇表.
7. McMurray等. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. [英]医学 2019.
8. Vos T等. 全球, 区域, 全国发病率, 患病率, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: A systematic analysis for the 全球 Burden of Disease Study 2016. 《澳门在线赌城娱乐》 2017; 390(10100):1211–59.
9. Mozaffarian D等. Heart Disease and Stroke Statistics-2016 Update: A Report From the 美国心脏协会. 循环 2016; 133(4):e38-360.
10. Mamas MA等. Do patients have worse outcomes in 心 failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. 心脏衰竭 2017; 19(9):1095–104.
11. Azad N, Lemay G. Management of chronic 心 failure in the older population. 老年心脏病 2014; 11(4):329–37.
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