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30 August 2020 16:00 BST
Farxiga是首个在伴有或不伴有2型糖尿病的慢性肾病患者肾脏结局试验中显著延长生存期的药物
突破性的III期DAPA-CKD临床试验的详细结果显示，澳门在线赌城娱乐的 Farxiga (dapagliflozin) on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo (p<0.0001)慢性肾脏疾病(CKD) 2-4期和尿白蛋白排泄升高的患者. The results were consistent in patients both with and without type-2 diabetes (T2D). CKD is a serious, 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 and the most common causes are diabetes, hypertension and glomerulonephritis.5
主要综合终点为肾小球滤过率(eGFR)持续下降≥50%。, onset of end-stage kidney disease (ESKD) and CV or renal death. The absolute risk reduction (ARR) was 5.3% over the median time in study of 2.4 years. The trial also met all secondary endpoints, including significantly reducing death from any cause by 31% (ARR = 2.1%, p=0.0035) compared to placebo.
The co-chairs of the DAPA-CKD trial and its Executive Committee Prof. David Wheeler, University College London, UK and Prof. Hiddo L. Heerspink, University Medical Center Groningen, the Netherlands, 他说:“令人印象深刻的DAPA-CKD试验结果对慢性肾病患者来说是一个显着的发展. 这些数据有可能改变这一患者群体的护理标准, which has a significant unmet need for new and improved treatment options.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “With today’s results, Farxiga 成为首个被证明可以显著延长合并或不合并2型糖尿病的慢性肾病患者生存期的SGLT2抑制剂，澳门第一赌城在线娱乐期待着与世界各地的监管机构分享这些数据. Farxiga 这也是同类药物中第一种对有或无2型糖尿病患者的心力衰竭和慢性肾脏疾病都有疗效的药物吗, 并降低2型糖尿病患者因心力衰竭和肾病住院的风险.”
The safety and tolerability of Farxiga were consistent with the well-established safety profile of the medicine. In the trial, patients treated with Farxiga experienced fewer serious adverse events compared to placebo (29.5% versus 33.9%, respectively). Diabetic ketoacidosis was not reported in the Farxiga group versus in two patients in the placebo group.
DAPA-CKD试验的详细结果于8月30日星期日在ESC大会2020 -数字体验上公布.
In May 2020, Farxiga 在美国获得批准，用于降低成人心力衰竭(NYHA II-IV级)伴射血分数(HFrEF)降低伴和不伴T2D的心力衰竭(hHF)患者心血管死亡和心力衰竭(hHF)住院的风险. Farxiga 目前正在对DELIVER(保留射血分数的HF)心衰(HF)患者进行评估, HFpEF) and DETERMINE (HFrEF and HFpEF) trials, 以及在急性心肌梗死(MI)或心脏病发作后无T2D的患者中进行的DAPA-MI试验-这是同类试验中的首例, indication-seeking registry-based randomised controlled trial.
Chronic kidney disease
CKD is a serious, 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), or both, for at least three months) affecting nearly 700 million people worldwide, many of them still undiagnosed.1-4 The most common causes of CKD are diabetes, hypertension and glomerulonephritis.5 In its most severe form, known as 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.6 The majority of patients with CKD will die from CV causes before reaching ESKD.7
DAPA-CKD
DAPA-CKD is an international, multi-centre, randomised, double-blinded trial in 4,304 patients designed to evaluate the efficacy of Farxiga 10mg, compared with placebo, in patients with CKD Stages 2-4 and elevated urinary albumin excretion, with and without 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 and renal death), the composite of CV death or hHF, and death from any cause. The trial was conducted in 21 countries and high-level results were announced in July 2020.
Farxiga
Farxiga (dapagliflozin) is a first-in-class, oral, 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 reduced the risk of the composite endpoint of hHF or CV death versus placebo, when added to standard of care. 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 patients, as well as more than 2.5 million patient-years’ experience.
AstraZeneca in CVRM
Cardiovascular, 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, kidneys and pancreas, 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.
AstraZeneca
AstraZeneca (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 - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, 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. Please visit charleighoffice.net and follow the Company on Twitter @AstraZeneca.
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References
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. Bikbov B et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: A systematic analysis for the Global Burden of Disease Study 2017. The Lancet 2020; 395(10225):709–33.
3. Hirst JA et al. 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 Pract 2020; 70(693):e285-e293.
4. National Kidney Foundation. Kidney Disease: The Basics; 2020 [cited 2020 Jun 29]. Available from: URL: http://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics.
5. National Kidney Foundation. Kidney Disease: Causes, 2017; [cited 2020 Jun 25]. Available from URL: http://www.kidney.org/atoz/content/kidneydiscauses
6. Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2019 [cited 01.05.20]. Available from URL: http://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html.
7. Briasoulis A, Bakris GL. Chronic Kidney Disease as a Coronary Artery Disease Risk Equivalent. Cur Cardiol Rep 2013; 15(3):340.
Adrian Kemp
Company Secretary
AstraZeneca PLC