2020年5月6日07:00
Farxiga is the first SGLT2 inhibitor proven to significantly reduce
the risk of cardiovascular death and hospitalisation for heart failure
澳门在线赌城娱乐公司 Farxiga (dapagliflozin)已在美国获得批准，用于降低伴有和不伴有2型糖尿病(T2D)的射血分数(HFrEF)降低的心力衰竭(NYHA II-IV级)患者心血管(CV)死亡和心力衰竭住院的风险。.
美国食品和药物管理局(FDA)的批准是基于具有里程碑意义的III期DAPA-HF试验的积极结果, 显示 Farxiga 实现具有统计学意义和临床意义的心血管疾病死亡或心力衰竭住院率的降低, 与安慰剂相比. 该决定是在 优先审查指定 granted by the FDA earlier this year and the 快速通道指定 2019年9月批准.
Farxiga 是美国FDA批准的首个用于治疗HFrEF (LVEF≤40%)患者的葡萄糖共转运蛋白2 (SGLT2)抑制剂。.
Mene Pangalos, Executive Vice President, 澳门第一赌城在线娱乐 R&D, said: “With the approval of Farxiga, 澳门第一赌城在线娱乐已经达到了一个关键的里程碑，有可能改变美国数百万患有心力衰竭的人的治疗方法. 通过提供急需的治疗，帮助减轻他们的疾病负担，延长他们的寿命，澳门第一赌城在线娱乐现在离对他们的生活产生重大影响又近了一步.”
约翰McMurray, MD, 心血管 Research Centre, Institute of 心血管 and Medical Sciences, 格拉斯哥大学, UK, said: “The ground-breaking results of the DAPA-HF trial have transformed heart failure therapeutics. 今天的批准为医生提供了一种全新的药理学方法，极大地改善了射血分数降低的心力衰竭患者的预后.”
The DAPA-HF trial showed that Farxiga, in addition to standard of care, 与安慰剂相比，CV死亡或HF恶化的复合结局风险降低26%(绝对风险降低[ARR] = 5%[事件发生率/100患者年:11]).6 vs 15.6, respectively]; p<0.0001) in patients with HFrEF. 在试验期间, 每21例接受心衰治疗的患者可避免1例心血管疾病死亡或心衰住院或与心衰相关的紧急就诊 Farxiga.
的安全概况 Farxiga in the DAPA-HF trial was consistent with the well-established safety profile of the medicine. The data from the DAPA-HF trial were published in The New England Journal of Medicine.1
2019年10月，美国FDA 批准 Farxiga 降低T2D合并心血管疾病或多重心血管危险因素的成年患者因心衰住院的风险. The approval was based on the DECLARE-TIMI 58 trial.
Farxiga 也被认为是饮食和运动的辅助，以改善成人糖尿病患者的血糖控制.
心脏衰竭
HF is a life-threatening disease in which the heart cannot pump enough blood around the body.2 全世界大约有6400万人患有此病(其中至少一半的人有射血分数降低)，美国有600万人患有此病.3–5 It is a chronic disease w在这里 half of patients will die within five years of diagnosis.6 T在这里 are two main categories of HF related to ejection fraction (EF), 测量每次心脏收缩时血液流出心脏的百分比:HFrEF和保留射血分数的心力衰竭(HFpEF).7 HFrEF occurs when the left ventricle (LV) muscle is not able to contract adequately and t在这里fore, expels less oxygen-rich blood in to the body.7, 8 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。.9 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.10
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, 4例双盲试验,744 patients with heart failure and reduced ejection fraction (LVEF ≤ 40%), 不论有无T2D, designed to evaluate the effect of Farxiga 10mg, compared with placebo, given once daily in addition to standard of care. The primary composite endpoint was time to the first occurrence of a worsening heart failure event (hospitalisation or equivalent event; i.e. an urgent heart failure visit), or cardiovascular death. The median duration of follow-up was 18.2个月.1
Farxiga
Farxiga (dapagliflozin) is a first-in-class, 口服SGLT2抑制剂每日一次，适用于成人T2D控制不足的单药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. In the DECLARE CV outcomes trial in adults with T2D, Farxiga reduced the risk of the composite endpoint of hospitalisation for HF or CV death versus placebo, when added to standard of care.11
Farxiga is currently also being evaluated for patients with chronic kidney disease (CKD) in the III期DAPA-CKD试验, 在数据监测委员会确定了压倒性的疗效后，该药物已被提前停止使用. FDA已经批准 快速通道指定 为了发展 Farxiga 在慢性肾病. 此外, Farxiga 在DELIVER (HFpEF)和DETERMINE function and symptom (HFrEF和HFpEF)试验中，是否也在对HF患者进行测试. Farxiga 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.5 million patient-years’ experience.
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 heart, 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/NYSE: 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, 肾脏与代谢, 和呼吸. 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 and follow the Company on 推特 @澳门在线赌城娱乐.
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参考文献
1. McMurray等. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. [英]医学 2019.
2. 梅奥诊所. 心脏衰竭; 2017 [cited 2019 Aug 14]. Available from: URL: http://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
3. Virani SS等. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. 循环 2020; 141(9):e139-e596.
4. Bhuiyan T, Maurer MS. Heart Failure with Preserved Ejection Fraction: Persistent Diagnosis, Therapeutic Enigma. 现任心血管风险代表 2011; 5(5):440–9.
5. 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.
6. Mozaffarian D等. 循环. 2016 Jan 26;133(4):e38-360 and the CDC: http://www.疾病预防控制中心.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm.
7. 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.
8. National Institute for Health and Care Excellence. Chronic heart failure in adults: diagnosis and management: NICE guideline [NG106]; 2018 [cited 2020 Apr 02]. 可从:URL: www.不错的.org.英国/指导/ ng106.
9. Mamas MA等. Do patients have worse outcomes in heart 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.
10. Azad N, Lemay G. Management of chronic heart failure in the older population. 老年心脏病 2014; 11(4):329–37.
11. Wiviott SD等. Dapagliflozin and 心血管 Outcomes in Type 2 Diabetes. [英]医学 2019; 380(4):347–57.
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