2020年10月2日07:00
根据DAPA-CKD III期试验结果，Farxiga在慢性肾脏疾病患者中显示出前所未有的肾功能衰竭和心血管或肾脏死亡风险降低
澳门在线赌城娱乐公司 Farxiga 达格列净(dapagliflozin)在美国获得突破性治疗认定(BTD)，用于治疗慢性肾脏疾病(CKD)患者。, with and without type-2 diabetes (T2D).
慢性肾病是一种严重的疾病, 以肾功能下降为特征的进行性疾病，通常与心脏病或中风风险增加有关.1,2,3 在美国， 37 million people are estimated to have CKD.1
美国食品和药物管理局(FDA)的BTD旨在加速潜在新药的开发和监管审查，这些新药旨在治疗严重疾病并解决重大未满足的医疗需求. 新药需要显示出令人鼓舞的早期临床结果，证明与现有药物相比，在临床显著终点有实质性改善.4
Mene Pangalos, Executive Vice President, 澳门第一赌城在线娱乐 R&D, said: “T在这里 is a serious, 对慢性肾脏疾病患者更好和更早治疗选择的未满足需求. Following the ground-breaking DAPA-CKD results, the Breakthrough 的rapy Designation is further testament to Farxiga’s potential to slow the progression of chronic 肾脏 disease. We look forward to working with the FDA to make Farxiga available to patients as quickly as possible.”
的 FDA granted BTD based on clinical evidence from the DAPA-CKD trial. 的 详细的结果 presented in August demonstrated that Farxiga 在标准护理的基础上，与安慰剂相比，将肾功能恶化、心血管(CV)或肾性死亡风险的综合测量值降低了39%(绝对风险降低[ARR] = 5).3%, p<0.0001)，同时也显著降低了31%的任何原因死亡(ARR = 2).1%, p=0.0035) compared to placebo.5
在美国， Farxiga 作为饮食和运动的辅助手段，可以改善成人T2D患者的血糖控制，并降低T2D合并心血管疾病或多重心血管危险因素的患者因心力衰竭(hHF)住院的风险. 今年5月, Farxiga 是 在美国获得批准 降低成人心力衰竭(HF) (NYHA II-IV级)伴射血分数(HFrEF)降低伴或不伴T2D的心血管死亡和hHF的风险.
慢性肾病
慢性肾病是一种严重的疾病, 以肾功能下降(表现为肾小球滤过率[eGFR]降低或肾损害标志物)为特征的进行性疾病, 或两个, for at least three months) affecting nearly 700 million people worldwide, many of them still undiagnosed.3,6-8 的 most common causes of CKD are diabetes, hypertension and glomerulonephritis. 9 CKD is associated with significant patient morbidity and an increased risk of CV events,3 such as HF and premature death.2 以最严重的形式, known as end-stage 肾脏 disease (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.1 的 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. 的 trial 是 conducted in 21 countries and 详细的结果 were 2020年8月宣布.
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抑制剂适用于成人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 hHF or CV death versus placebo, 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/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 & 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.
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参考文献
1. 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.疾病预防控制中心.gov/肾脏disease/publications-resources/2019-national-facts.html.
2. 西格尔·L等. Heart failure in patients with chronic 肾脏 disease: A systematic integrative review. 生物医学研究中心 2014; 2014:937398
3. Bikbov B等. 全球, 区域, and national burden of chronic 肾脏 disease, 1990–2017: A systematic analysis for the 全球 Burden of Disease Study 2017. 《澳门第一赌城在线娱乐》 2020; 395(10225):709–33.
4. U.S. Food and Drug Administration. Frequently Asked Questions: Breakthrough 的rapies [cited 2020 Sep 28]. 可从:网址: http://www.食品及Medicines管理局.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-食品及Medicines管理局sia/frequently-asked-questions-breakthrough-therapies
5. Heerspink H. DAPA-CKD - Dapagliflozin in Patients with Chronic Kidney Disease. presented at: ESC Congress 2020 - 的 Digital Experience, 2020 August 29 - September 01
6. Kidney Disease: Improving 全球 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.
7. 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.
8. National Kidney Foundation. Kidney Disease: 的 Basics; 2020 [cited 2020 Sep 23]. 可从:网址: http://www.Renal脏.org/news/newsroom/factsheets/KidneyDiseaseBasics
9. National Kidney Foundation. Kidney Disease: Causes; 2015 [cited 2020 Sep 23]. 可从:网址: http://www.Renal脏.org/atoz/content/Renal脏discauses
10. Briasoulis A, Bakris GL. Chronic Kidney Disease as a Coronary Artery Disease Risk Equivalent. Current Cardiology Reports 2013; 15(3):340
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