福昔加在中国获批，用于降低有症状慢性心力衰竭成人患者心血管死亡和住院风险

第一个也是唯一的心力衰竭治疗与证明死亡率效益现在批准的患者心力衰竭，无论射血分数状态
 

Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, 心力衰竭住院(HF), or urgent HF visits in adults with symptomatic chronic HF. Forxiga 此前已在中国批准用于降低射血分数(HFrEF)的HF患者，这意味着 Forxiga 目前在中国被批准用于降低有症状的慢性心力衰竭成年患者心血管死亡和住院的风险，无论射血分数表型如何.

中国国家药品监督管理局(NMPA)的批准是基于交付 III期试验的积极结果. 预先指定的交付和DAPA-HF III期试验的汇总分析结果也证实，达格列净是首个在全射血分数范围内证明具有死亡率优势的HF药物.^1,2

路德浮标, 执行副总裁, and President 澳门第一赌城在线娱乐 Business Unit, 澳门在线赌城娱乐, 他说:“这一更广泛的迹象表明 Forxiga 在有症状的慢性心力衰竭的成年人中，整个射血分数范围对患者来说是一个显著的进步. 鉴于治疗需求未得到满足，而且迄今为止还没有降低这种情况下死亡率的治疗方法，这代表着与心力衰竭作斗争的一个令人兴奋的转折点. 重要的是, 这一进展凸显了澳门第一赌城在线娱乐加快早期发现和协调治疗的承诺, to address the complexities of heart failure across the disease spectrum.”

HF is a complex syndrome that occurs when the heart cannot pump enough blood around the body.³ HF大约影响4.中国有500万人口.⁴ Around half of HF patients die within five years of diagnosis.⁵ 射血分数高于40%的患者有更大的死亡和住院风险，并经历特别高的症状负担和身体限制, and consequently have a poor quality of life.⁶ The economic burden of HF in China is huge in terms of healthcare costs and resource utilisation, 住院是造成心衰治疗负担的主要因素——心衰患者一年中平均住院时间为30天.⁷

Forxiga is also approved for the treatment of patients with T2D, HFrEF 和慢性肾病 in more than 100 countries around the world including China, 日本, 美国, 和欧盟.

笔记

心脏衰竭
心脏衰竭 (HF) is a chronic, long-term condition that worsens over time.⁸ It affects nearly 64 million people globally⁹ and is associated with substantial morbidity and mortality.¹⁰ 慢性心衰是65岁以上人群住院的主要原因，是一个重大的临床和经济负担.¹¹ T在这里 are several types of HF often defined by left ventricular ejection fraction (LVEF), a measurement of the percentage of blood leaving the heart each time it contracts, including HFrEF (LVEF less than or equal to 40%), HFmrEF (LVEF 41-49%) and HFpEF (LVEF greater than or equal to 50%).¹² 大约一半的心衰患者有HFmrEF或HFpEF，可用的治疗选择很少.¹³

交付 
交付(达格列净评价改善保留射血分数心力衰竭患者的生活)是一项国际研究, 随机, 双盲, 与这些相应平行的组织, 安慰剂对照, event-driven Phase III trial designed to evaluate the efficacy of Forxiga, 与安慰剂相比, in the treatment of HF patients with LVEF above 40%, 伴有或不伴有2型糖尿病(T2D). 交付 is the largest clinical trial to date in HF patients with LVEF above 40%, 与6,263名随机患者.¹⁴ Results from the 交付 Phase III trial showed that Forxiga 达到了主要终点，心血管(CV)死亡或心衰恶化的复合结局降低了18% (16.4% Forxiga 第19组.5% in the placebo group over a median follow-up of 2.3年[风险比{HR} =0.82 {95% CI 0.73-0.92}; p<0.001, ar3.1%]).¹⁴

DAPA-HF 
DAPA-HF(达格列净和预防心力衰竭不良后果)是一项国际研究, 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,744例HFrEF患者, 不论有无T2D, 评价的:用来评价…的效果的 Forxiga 10mg, 与安慰剂相比, given once daily in addition to standard of care. 主要综合终点为首次发生恶化心衰事件(住院或同等事件)的时间, i.e., an urgent HF visit), or cardiovascular (CV) death. 中位随访时间为18.2个月.¹⁵ 关键次要终点包括HF住院总人数(包括重复入院)和CV死亡人数, 堪萨斯城心肌病问卷(KCCQ)总症状评分从基线到8个月的变化.¹⁵

Forxiga (dapagliflozin)
Forxiga 是头等舱吗, 口服, once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2). Forxiga is indicated to reduce the risk of cardiovascular death, HF住院, or urgent HF visits in adults with symptomatic chronic heart failure.¹⁶ Forxiga 在中国也被批准用于成人慢性肾脏疾病(CKD)和治疗控制不充分的2型糖尿病(T2D)，作为饮食和运动的辅助疗法.  研究表明  Forxiga的 efficacy in preventing and delaying cardiorenal disease, 同时也保护了器官——这一重要发现考虑到心脏和心脏之间的潜在联系, 肾脏, 和胰腺.^{15, 17-18} Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, 包括T2D, HF, 和慢性肾病.^{3, 9, 19-20}

澳门在线赌城娱乐在crvrm
心血管，肾脏和代谢 (CVRM), 澳门第一赌城在线娱乐的一部分, forms one of 澳门在线赌城娱乐’s main disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, 肾脏, 肝脏和胰腺, 澳门在线赌城娱乐正在投资一系列药物，通过减缓或阻止疾病进展来保护器官, and ultimately paving the way towards regenerative therapies. The Company’s ambition is to improve and save the lives of millions of people, 通过更好地理解crvrm疾病之间的相互联系，并针对驱动它们的机制, 所以澳门第一赌城在线娱乐可以检测, diagnose and treat people earlier and more effectively.

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, 发展, and commercialisation of prescription medicines in 肿瘤学, 罕见疾病, 和澳门第一赌城在线娱乐, 包括心血管, 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 并在社交媒体上关注公司 @澳门在线赌城娱乐

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