This announcement contains inside information
2020年7月28日07:00英国夏令时
Farxiga significantly reduced the worsening of renal function or risk of death
in patients with chronic 肾脏 disease with and without type-2 diabetes
高级结果来自 Farxiga(dapagliflozin)的III期DAPA-CKD试验显示，其主要终点(肾功能恶化或死亡风险的复合终点)(定义为估计肾小球滤过率(eGFR)持续下降≥50%的复合终点)具有统计学意义和临床意义。, 成年慢性肾病(CKD)患者终末期肾病(ESKD)或心血管(CV)或肾性死亡的发病. 该试验在伴有和不伴有2型糖尿病(T2D)的CKD患者中也达到了所有次要终点。, 使 Farxiga 这是第一种显著降低这一患者群体因任何原因死亡风险的药物.
慢性肾病是一种严重的疾病, 以肾功能下降为定义的进行性疾病影响全球近7亿人,1,2 many of them still undiagnosed.3,4 Currently t在这里 are limited treatment options for these patients.5 CKD与显著的患者发病率和心血管事件风险增加相关。6 such as heart failure (HF) and premature death.7
The co-chairs of the trial and its Executive Committee Prof. David Wheeler, University College London, and Prof. Hiddo L. Heerspink, University Medical Center Groningen, 他说:“DAPA-CKD试验显示了达格列净作为慢性肾病患者期待已久的新治疗选择的潜力. The data will be transformative for these patients.”
Mene Pangalos, Executive Vice President, 澳门第一赌城在线娱乐 R&D, said: “DAPA-CKD is the first trial to demonstrate overwhelming efficacy, including improvement on survival, in chronic 肾脏 disease patients both with and without type-2 diabetes. We look forward to sharing these exciting Farxiga results with the scientific community and health authorities worldwide.”
The safety and tolerability profile for Farxiga was consistent with the well-established safety profile of the medicine.
完整的DAPA-CKD试验结果将提交给即将召开的医学会议.
In 2020年3月, 澳门在线赌城娱乐宣布，在独立数据监测委员会基于其压倒性疗效的建议下，DAPA-CKD试验被提前停止.
此外,在 2020年5月, Farxiga 在美国被批准用于降低成人HF (NYHA II-IV级)伴射血分数(HFrEF)降低伴和不伴T2D的心衰(hHF)患者的CV死亡和住院风险. Farxiga is also under review with the European 药物 Agency, as well as in other regions, for the treatment of patients with HF.
慢性肾病
慢性肾病可能是一种严重的疾病, 以肾功能下降为特征的进行性疾病(表现为eGFR降低或肾损害标志物), 或两个, for at least three months).1 The most common causes of CKD are diabetes, hypertension and glomerulonephritis.8 以最严重的形式, 称为ESKD, 肾损害和肾功能恶化已发展到需要透析或肾移植的阶段.9 The majority of patients with CKD will die from CV causes before reaching ESKD.10
DAPA-CKD
DAPA-CKD is an international, 的多中心, 随机, double-blinded trial in 4,304 patients designed to evaluate the efficacy of Farxiga 10mg, 与安慰剂相比, in patients with CKD Stages 2–4 and elevated urinary albumin excretion, 不论有无T2D. Farxiga is given once daily in addition to standard of care. 主要综合终点是肾功能恶化或死亡风险(定义为eGFR下降≥50%的综合终点), onset of ESKD and death from CV or renal cause). 次要终点包括首次出现肾脏复合物的时间(持续≥50%的eGFR下降), ESKD和肾性死亡), the composite of CV death or hHF, and death from any cause. The trial was conducted in 21 countries.
Farxiga
Farxiga (dapagliflozin) is a first-in-class, 口服, 每日一次的钠-葡萄糖共转运蛋白-2 (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. In the DECLARE CV outcomes trial in adults with T2D, Farxiga 与安慰剂相比，降低了HF或CV死亡住院的复合终点的风险, when added to standard of care.
Farxiga 目前正在对DELIVER(保留射血分数的HF)患者进行试验, HFpEF) and DETERMINE (HFrEF and HFpEF) trials. Farxiga 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. 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. 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 co-morbidities. 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 & Metabolism, and 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 and follow the Company on 推特 @澳门在线赌城娱乐.
联系人
For details on how to contact the 投资者关系 Team, please click 在这里. For 媒体联系人, click 在这里.
参考文献
1. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012慢性肾脏疾病评估与管理临床实践指南. Kidney International Supplement 2013; (3):1–150.
2. GBD 2017全球, 区域, 全国发病率, 患病率, 195个国家和领土的354种疾病和伤害的残疾寿命, 1990–2017: asystematic analysis for the Global Burden of Disease Study 2017 《澳门第一赌城在线娱乐》 2018; 392:1789–858.
3. National Kidney Foundation. Kidney Disease: The Basics [cited 07.08.20]. 可从:网址: http://www.Renal脏.org/news/newsroom/factsheets/KidneyDiseaseBasics.
4. Hirst JA等. 使用来自OxRen的数据的社区慢性肾脏疾病患病率:一项基于英国人群的队列研究. Br J Gen practice 2020; 70(693):e285-e293.
5. 病房F等. Drug therapies to delay the progression of chronic 肾脏 disease. Clin Med (Lond) 2015; 15(6):550–7
6. Bikbov, Boris等. “全球, 区域, and National Burden of Chronic Kidney Disease, 1990–2017: a Systematic Analysis for the Global Burden of Disease Study 2017.《澳门第一赌城在线娱乐》，卷. 395, no. 2月13日. 2020, pp. 709–733., doi: 10.1016/s0140-6736(20)30045-3.
7. 西格尔·L等. Heart failure in patients with chronic 肾脏 disease: A systematic integrative review. Biomed Res Int 2014; 2014:937398.
8. National Kidney Foundation. Kidney Disease: Causes, 2017; [cited 2020 Jun 25]. 可从网址下载: http://www.Renal脏.org/atoz/content/Renal脏discauses
9. Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2019 [cited 01.05.20]. 可从网址下载: http://www.cdc.gov/Renal脏disease/publications-resources/2019-national-facts.html.
10. Briasoulis A, Bakris GL. Chronic Kidney Disease as a Coronary Artery Disease Risk Equivalent. 当前的心血管系统 2013; 15(3):340.
艾德里安·坎普
公司秘书
澳门在线赌城娱乐