AstraZeneca advances leadership in renal disease with more than 80 abstracts 2020年重新想象的ASN肾脏周

20 October 2020 07:00 BST
 

For roxadustat, more than 40 abstracts present safety and efficacy outcomes in anaemia of chronic kidney disease

For Farxiga, 来自DAPA-CKD III期试验的新亚组数据评估了与慢性肾脏疾病病因无关的潜在益处

数据显示,在帮助预防或减缓慢性肾脏疾病进展和解决危及生命的并发症方面取得了进展
 

澳门在线赌城娱乐将呈报84篇摘要, 包括12份口头报告和3份最新摘要, 在其行业领先的肾脏产品组合中,包括罗沙司他, Farxiga (dapagliflozin) and Lokelma (sodium zirconium cyclosilicate), 2020年重新想象的ASN肾脏周, 将于2020年10月22日至25日举行.

这些数据推进了澳门在线赌城娱乐的雄心,即为肾脏患者创建一个协调的途径,以促进早期诊断,帮助预防或减缓慢性肾脏疾病(CKD)的进展,并解决其危及生命的并发症, such as anaemia and hyperkalaemia.1,2

Mene Pangalos,澳门第一赌城在线娱乐R的执行副总裁&D, said: “The breadth of data being presented by AstraZeneca demonstrates the growing momentum of our renal portfolio. Our ambition is to provide new treatments for hundreds of millions of patients with chronic kidney disease, 一种目前无法治愈的渐进性疾病. 澳门第一赌城在线娱乐特别兴奋地分享罗沙司他治疗慢性肾病贫血的安全性和有效性的见解,以及来自DAPA-CKD试验的新亚组数据 Farxiga regardless of disease cause.”

罗沙司他-重新定义CKD贫血的管理

将发表40多篇关于罗沙他的摘要, 一种一流的口服缺氧诱导因子脯氨酸羟化酶抑制剂(HIF-PHI). 摘要提供了新的见解,该药物的潜力,以改变治疗标准的贫血慢性肾病的关键患者亚群, notably:

  • III期试验汇总分析的最新报告 研究透析依赖(DD)和非透析依赖(NDD)-CKD患者血红蛋白水平与CV结果之间的关系. 心血管(CV)结局是CKD患者常见且严重的并发症.3-5
  • An oral presentation exploring whether roxadustat can reduce the risk of hospitalisation for heart failure, 慢性肾病患者常见的合并症.6
  • Analyses of whether roxadustat has the potential to reduce the risk of red blood cell (RBC) transfusions, 一种治疗伴有其他并发症的贫血的方法, 在DD-CKD和NDD-CKD患者中.7
  • An analysis exploring the effect of roxadustat on achieving haemoglobin levels ≥10 g/dL in patients with NDD-CKD.8
  • 来自DD-CKD患者亚组III期试验汇总分析的新数据, 包括那些正在接受腹膜透析和透析新手.9,10

Farxiga -为早期CKD保护制定新标准

New late-breaking subgroup data from the ground-breaking DAPA-CKD Phase III trial evaluating the potential benefit of Farxiga 在CKD患者中,无论潜在原因如何.11 Detailed results presented in August and published in 新英格兰医学杂志 established Farxiga 在CKD合并和不合并2型糖尿病(T2D)患者的肾脏结局试验中,作为第一种显著延长生存期的药物。.

Lokelma ——积极推进钾管理

DIALIZE iii期ib试验的新亚分析和CKD和高钾血症患者的真实证据表明 Lokelma 作为高钾血症治疗的一种选择.12-14 Hyperkalaemia is a common complication in patients with CKD and can result in serious arrhythmias, sudden cardiac arrest, paralysis and weakness, and even death.2,15,16 If not managed effectively, 高钾血症等并发症会影响正在进行的治疗方法, 导致挽救生命的治疗减少或停止.16

揭示CKD患者群体独特的未满足需求

澳门在线赌城娱乐还将介绍CKD患者生活经历的新见解,以及治疗和管理方面的可操作差距. discovery - ckd将提供新的数据, a trial that assesses current real-world practice patterns and clinical management of patients with CKD. 它揭示了疾病负担和决定不良临床结果的因素, 强调需要改进治疗方案.17


澳门在线赌城娱乐在ASN肾脏周2020上的关键摘要包括:

ASN肾脏周2020摘要可获得 online.


Roxadustat

Roxadustat is a first-in-class oral small molecule hypoxia-inducible-factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increased endogenous production of erythropoietin; improved iron absorption, transport and mobilisation; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on haemoglobin synthesis and red blood cell production. Roxadustat在中国被批准用于治疗成年CKD患者的贫血, 有透析的,也有不透析的. In Japan, roxadustat被批准用于CKD透析患者的贫血治疗, 用于治疗非透析CKD患者贫血的补充新药申请(NDA)正在监管审查中. roxadustat用于治疗NDD和DD的CKD贫血的NDA正在接受美国食品和药物管理局的审查,预计将于2020年第四季度做出决定. roxadustat用于治疗NDD和DD的CKD贫血的上市许可申请由安斯泰来提交,并于2020年5月21日被欧洲药品管理局接受审查. 罗沙司他还处于临床开发阶段,用于治疗骨髓增生异常综合征(MDS)相关的贫血和化疗引起的贫血(CIA)。.

AstraZeneca and FibroGen Inc. (FibroGen) are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in the US, 中国以及美洲和澳大利亚/新西兰的其他市场, as well as Southeast Asia. 安斯泰来和FibroGen正在合作开发和商业化roxadustat,用于包括日本在内的地区的潜在贫血治疗, Europe, 独立国家联合体, the Middle East and South Africa. 2020年重新想象的ASN肾脏周, roxadustat数据将由安斯泰来赞助和展示, AstraZeneca and FibroGen.

Farxiga

Farxiga (达格列净)是一流的, oral, 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, 还有额外的减肥和降血压的好处. 在成人T2D患者的DECLARE CV结局试验中, Farxiga reduced the risk of the composite endpoint of hospitalisation for heart failure (hHF) or CV death versus placebo, when added to standard of care.

In May 2020, Farxiga 在美国被批准用于降低成人心力衰竭(HF) (NYHA II-IV级)伴射血分数(HFrEF)降低伴和不伴T2D的hHF患者的CV死亡和hHF风险. 在针对CKD患者的DAPA-CKD III期试验中, Farxiga 满足所有主要和次要终点,提供压倒性的疗效. Farxiga is currently being tested for patients with HF in the DELIVER (HF with preserved ejection fraction, HFpEF)和decide (HFrEF和HFpEF)试验. 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, 循证注册的随机对照试验. Farxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.500万病人年的经验.

Lokelma  

Lokelma (环硅酸锆钠)是一种不溶物, 不吸收的硅酸锆钠, 配制成粉末用于口服悬浮液, 这是一种高选择性的除钾药物. 口服,无臭,无味,在室温下稳定. 它已经在三个双盲实验中进行了研究, placebo-controlled trials and one 12-month open-label clinical trial in patients with hyperkalaemia.

AstraZeneca in CVRM

心血管,肾脏和代谢 (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, 减少风险和处理合并症. 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

澳门在线赌城娱乐(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门第一赌城在线娱乐公司,专注于发现, 处方药的开发和商业化, 主要用于治疗肿瘤等三个治疗领域的疾病, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit charleighoffice.net and follow the Company on Twitter @AstraZeneca.

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References

1. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis 2006; 47(5 Suppl 3):S1-146.

2. National Kidney Foundation. Clinical Update on Hyperkalemia: A chronic Risk for CKD Patients and a Potential Barrier to Recommended CKD Treatment. New York: National Kidney Foundation; 2014 [cited 16 October 2020]. Available from: URL: http://www.kidney.org/sites/default/files/02 - 10 - 6785 _hbe_hyperkalemia_bulletin.pdf.

3. Fishbane S et al. 罗沙司他治疗依赖透析的慢性肾病贫血患者的3期合并试验中达到的血红蛋白与心血管预后之间的关系. Abstract #PO2625 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.

4. Provenzano R et al. 在非透析依赖的慢性肾病贫血患者的罗沙司他3期研究中,达到的血红蛋白与心血管预后之间的关系. Abstract # #PO2626 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.

5. 美国疾病控制与预防中心. Chronic Kidney Disease: Common - Serious - Costly; 12 December 2019 [cited 16 October 2020]. Available from: URL: http://www.cdc.gov / kidneydisease prevention-risk / CKD-common-serious-costly.html.

6. Provenzano R et al. 罗沙司他3期研究的汇总分析:罗沙司他治疗的透析和非透析贫血患者的充血性心力衰竭住院率与比较. Abstract #SA-OR39 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.

7. Fishbane S et al. 罗沙司他降低慢性肾病贫血患者输血风险. Abstract #PO0256 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.

8. Rastogi, A et al. 罗沙司他治疗可纠正大多数非透析依赖型慢性肾病(NDD-CKD)患者血红蛋白(Hb)值≥10 g/dL的贫血. Abstract #PO0264 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.

9. Chan, TM et al. Efficacy and Safety of Roxadustat in Patients with Dialysis-dependent Chronic Kidney Disease and Anemia on Peritoneal Dialysis. Oral #SU-OR24 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.

10. Provenzano R et al. 罗沙司他治疗急性透析依赖性慢性肾病患者贫血疗效的亚组分析摘要#PO0259发表于:美国肾脏病学会肾周2020年, 19-25 October 2020.

11. Wheeler D. 达格列净对肾功能的影响, cardiovascular events and all-cause mortality according to cause of kidney disease in the DAPA-CKD trial. Abstract #FR-OR58 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.

12. Fishbane S. 高钾血症血液透析患者低钾血症的风险. Abstract #PO1051 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.

13. 刘建军,刘建军,刘建军,刘建军,刘建军. The relationship between comorbidities and hyperkalaemia in patients with chronic kidney disease. Abstract #PO1448 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.

14. 刘建军,刘建军,刘建军,刘建军,刘建军. The relationship between chronic kidney disease duration, serum potassium level and adverse outcomes. Abstract #PO1450 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.

15. American Heart Association. Part 10.1:危及生命的电解质异常. Circulation 2005; 112(24_suppl):IV-121-IV-125.

16. Montford JR et al. How Dangerous is Hyperkalaemia? J Am Soc Nephrol. 2017 Nov;28(11):3155-3165.

17. U.S. National Institutes of Health. A Study on Patients With Chronic Kidney Disease (CKD) to Assess Treatment Experience and Patterns, Effect of the Treatment, Patient Outcomes and Patient Quality of Life (DISCOVER CKD) [Identifier: NCT04034992] [cited 16 October 2020]. 可从:URL: http://clinicaltrials.gov/ct2/show/NCT04034992.


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