2020年11月5日07:05 GMT
Forxiga是第一个在欧盟批准用于心力衰竭的SGLT2抑制剂
有2型糖尿病和无2型糖尿病的成人患者射血分数降低
澳门在线赌城娱乐公司 Forxiga (dapagliflozin) has been approved in the European Union (EU) for the treatment of symptomatic chronic 心 failure with reduced ejection fraction (HFrEF) in adults with and without type-2 diabetes (T2D).
心脏衰竭 (HF) is a life-threatening chronic disease that prevents the 心 from pumping sufficient levels of blood around the body. 它影响了欧盟的1500万人，其中至少有一半人的射血分数降低，1-3 which occurs when the left ventricle muscle is not able to contract adequately and t在这里fore expels less oxygen-rich blood into the body.4-6
The approval by the European Commission is based on positive results from the landmark DAPA-HF Phase III trial, 发表在 新英格兰医学杂志.7 它遵循 建议批准 由欧洲药品管理局人用医药产品委员会负责.
约翰McMurray, MD, 心血管研究中心, 心血管和医学科学研究所, 格拉斯哥大学, UK, said: “Today’s approval provides physicians with a completely novel treatment for 心 failure with reduced ejection fraction, 不仅能改善症状，还能减少住院率, 同时也提高了这种危及生命的疾病的存活率.”
Mene Pangalos，澳门第一赌城在线娱乐R的执行副总裁&D，说:“有了这个批准 Forxiga，澳门第一赌城在线娱乐就可以重新定义欧盟数百万心力衰竭患者的护理标准. We are another step closer to achieving our ambition of preventing or treating 心 failure by providing a treatment that can significantly reduce cardiovascular death and hospitalisation.”
Forxiga is the first sodium-glucose co-transporter-2 (SGLT2) inhibitor to have shown a statistically significant reduction in the risk of the composite of cardiovascular (CV) death or worsening of HF events, 包括因心衰住院(hHF). DAPA-HF III期试验表明 Forxiga, 除了标准护理之外, reduced the risk of the composite outcome versus placebo by 26% and both components of the primary composite endpoint contributed benefit to the overall effect. 在DAPA-HF III期试验中 Forxiga 是否符合既定的药物安全性. 审判期间, 每治疗21例患者可避免1例CV死亡或hHF或与HF相关的紧急就诊.
Forxiga (被称为 Farxiga in the US) is approved in the US for the treatment of patients with HFrEF and is currently under review in Japan and in several over countries around the world.
Forxiga 随着科学的发展，心脏和心脏之间的潜在联系是否得到了进一步的确认, 肾脏和胰腺. DAPA-HF是DapaCare的一部分, 一个强大的临床试验计划来评估潜在的心血管和肾脏益处 Forxiga. The programme has also explored the treatment of patients with chronic kidney disease (CKD) in the ground-breaking DAPA-CKD Phase III trial. 此外, Forxiga is currently being tested for HF patients with preserved ejection fraction (HFpEF) in the DELIVER Phase III trial with data anticipated in the second half of 2021.
心脏衰竭
HF affects approximately 64 million people worldwide (at least half of whom have a reduced ejection fraction), 其中欧盟有1500万人，美国有600万人.2-3,8 这是一种慢性疾病，一半的患者将在确诊后五年内死亡.9 与射血分数(EF)相关的心衰主要有两类。, 测量心脏每次收缩时流出血液的百分比:HFrEF和HFpEF.7 当左心室肌肉不能充分收缩时，就会发生HFrEF, 向体内排出的富氧血液较少.5,6 HF remains as fatal as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancer).10 It is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden.11
DAPA-HF
DAPA-HF(达格列净和预防心力衰竭不良后果)是一项国际性研究, 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,心力衰竭伴射血分数降低(LVEF≤40%)744例, 不论有无T2D, 评价的:用来评价…的效果的 Forxiga 10mg，与安慰剂相比，在标准治疗的基础上每天给予一次. The primary composite endpoint was time to the first occurrence of a worsening 心 failure event (hospitalisation or equivalent event; i.e. 紧急心力衰竭就诊)或心血管死亡. 中位随访时间为18.2个月.
Forxiga
Forxiga (达格列净)是一流的, 口服, once-daily SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, 还有额外的减肥和降血压的好处.
Forxiga 在III期DAPA-CKD试验中对CKD患者进行了评估, 随着全部结果的公布 2020年8月 证明 Forxiga 满足所有主要和次要终点，提供压倒性的疗效. Forxiga 目前正在对DELIVER(保留射血分数的HF)患者进行试验, HFpEF和decide (HFrEF和HFpEF) III期试验. Forxiga will also be tested in patients without T2D following an acute myocardial infarction (MI) or 心 attack in the DAPA-MI trial - a first of its kind, indication-seeking, 基于注册的随机对照试验. Forxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000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) together forms one of 澳门在线赌城娱乐公司 three therapy areas and is a key growth driver for the Company. 通过遵循科学来更清楚地了解心脏之间的潜在联系, 肾脏和胰腺, 澳门在线赌城娱乐 is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, 减少风险和处理合并症. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
澳门在线赌城娱乐
澳门在线赌城娱乐(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门第一赌城在线娱乐公司，专注于发现, 处方药的开发和商业化, 主要用于治疗肿瘤等三个治疗领域的疾病, 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 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 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
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2. 迪克斯坦K等人. ESC Guidelines for the diagnosis and treatment of acute and chronic 心 failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). 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 Guidelines for the diagnosis and treatment of acute and chronic 心 failure: The Task Force for the diagnosis and treatment of acute and chronic 心 failure of the European Society of Cardiology (ESC) Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. 欧洲心脏 2016; 37(27):2129–200.).
6. 国家指南中心(英国). 成人慢性心力衰竭:诊断和管理. London: National Institute for Health and Care Excellence (UK); 2018 Sep. (NICE指南，No. 106.13、词汇表.
7. McMurray等. 达格列净在心力衰竭和射血分数降低患者中的作用. [英]医学 2019.
8. Vos T等. 全球, 区域, 全国发病率, 患病率, 195个国家的328种疾病和伤害导致残疾的年数, 1990-2016: 2016年全球疾病负担研究的系统分析. 《澳门在线赌城娱乐》 2017; 390(10100):1211–59.
9. Mozaffarian D等. 心脏病和中风统计-2016年更新:来自美国心脏协会的报告. 循环 2016; 133(4):e38-360.
10. Mamas MA等. 心力衰竭患者的预后比癌症患者差吗? 苏格兰一项以初级保健为基础的队列研究，随访10年. 心脏衰竭 2017; 19(9):1095–104.
11. Azad N, Lemay G. 老年人群慢性心力衰竭的管理. 老年心脏病 2014; 11(4):329–37.
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