Farxiga showed cardiovascular and renal benefit in patients with chronic kidney disease irrespective of cardiovascular disease status-澳门葡京网赌游戏

PUBLISHED 13 November 2020

来自DAPA-CKD III期试验的新亚组分析数据显示 Farxiga (dapagliflozin) reduced the risk of the primary composite of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% versus placebo in patients with chronic kidney disease (CKD) with and without type-2 diabetes (T2D), 无论他们的CV病史状况如何. 绝对风险分别降低了5%和6%, for patients without CV disease at baseline and patients with CV disease at baseline; p-value for interaction = 0.90. ¹

The subgroup analysis evaluated the trial’s primary endpoint of worsening of renal function or risk of CV or renal death as well as secondary endpoints in subgroups of patients at baseline without a history of CV disease (“primary prevention” patients, 37.4% of trial participants) and in patients with CV disease (“secondary prevention” patients, 62.4% of trial participants). 与初级预防患者的基线比较, 二级预防患者年龄较大, more often male, and smokers, 平均收缩压较高, and higher body mass index. Additionally, patients with CV disease were more likely to have T2D than those without CV disease.¹

John McMurray, MD, 心血管研究中心, 心血管和医学科学研究所, University of Glasgow, UK, and member of the DAPA-CKD Executive Committee said: “These data show that even the most at-risk patients experienced consistent benefit from dapagliflozin, 降低肾衰竭的风险, 死于心血管疾病或因心力衰竭住院, as well as prolonged survival.”

Mene Pangalos，澳门葡京赌博游戏R的执行副总裁&D, said: “This study further emphasises that patients with chronic kidney disease are at a heightened risk of adverse cardiovascular and renal outcomes, 包括任何原因导致的死亡. We are excited to see dapagliflozin 在这些患者中显示出持续的益处, 不管他们的心血管疾病状况如何, 并致力于潜在地帮助他们活得更长, healthier lives.”

主要和次要终点根据基线心血管疾病状态.

的安全性和耐受性 dapagliflozin 是否符合既定的药物安全性.

The data were presented at the American Heart Association 2020 Scientific Sessions and were published in Circulation. 试验的详细结果如下 shared earlier this year and published in 新英格兰医学杂志.

Last month, dapagliflozin was granted Breakthrough Therapy Designation in the US for patients with CKD, with and without T2D.

Chronic kidney disease

CKD is a serious, progressive condition defined by decreased kidney function (shown by reduced estimated glomerular filtration rate [eGFR] or markers of kidney damage, or both, 至少持续三个月)，影响全球近7亿人, 其中许多人仍未得到诊断.^2–5 慢性肾脏病最常见的病因是糖尿病、高血压和肾小球肾炎.⁶ CKD与显著的患者发病率和心血管事件风险增加相关。³ 例如心力衰竭和过早死亡.⁷ In its most severe form, 终末期肾病(ESKD), kidney damage and deterioration of kidney function have progressed to the stage where dialysis or kidney transplantation are required.⁸ 大多数CKD患者在达到ESKD之前会死于CV原因.⁹

DAPA-CKD

DAPA-CKD is an international, multi-centre, randomised, double-blinded trial in 4,304名患者被设计用来评估达格列净的疗效 10mg, compared with placebo, CKD 2-4期和尿白蛋白排泄升高的患者, with and without T2D. 在标准治疗的基础上，每天给予达格列净一次. Detailed results showed that dapagliflozin reduced the risk of the composite measure of worsening of renal function or CV or renal death (defined as ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease (ESKD) or CV or renal death) by 39% compared to placebo (absolute risk reduction [ARR] = 5.比研究2的中位时间多3%.4 years; p <0.0001]). 结果在有和没有T2D的患者中都是一致的. Dapagliflozin also met all secondary endpoints (renal composite of ≥50% sustained decline in eGFR, ESKD or renal death; composite of CV death and hHF) including significantly reducing the risk of death from any cause by 31% (ARR = 2.1%; p =0.0035) compared to placebo.¹⁰

Farxiga

Farxiga (达格列净)是一流的, oral, once-daily sodium-glucose co-transporter-2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, 还有额外的减肥和降血压的好处. DECLARE-TIMI 58成人T2D CV结局试验, 与安慰剂相比，达格列净降低了hHF或CV死亡复合终点的风险, when added to standard of care.

In May 2020, dapagliflozin was approved in the US to reduce the risk of CV death and hHF in adults with HF (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D. Dapagliflozin is currently being tested for patients with HF in the DELIVER (HF with preserved ejection fraction, HFpEF和decide (HFrEF和HFpEF) III期试验. Dapagliflozin will also be tested in patients without T2D following an acute myocardial infarction (MI) or heartattack in the DAPA-MI trial - a first of its kind, 循证注册的随机对照试验. Dapagliflozin 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.

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. 通过遵循科学来更清楚地了解心脏之间的潜在联系, 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. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.

AstraZeneca

澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门葡京赌博游戏公司，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 ospifse.net 并在Twitter上关注公司 @AstraZeneca.

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References

1. McMurray J. 达格列净对慢性肾病患者临床结局的影响, 不管有没有心血管疾病. 在2020年11月13日至17日的AHA科学会议上发表.

2. 肾脏疾病:改善全球预后(KDIGO) CKD工作组. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. 国际肾脏补品 2013; (3):1–150.

3. Bikbov B et al. Global, regional, 以及慢性肾病的国家负担, 1990-2017: 2017年全球疾病负担研究的系统分析. The Lancet 2020; 395(10225):709–33.

4. Hirst JA et al. Prevalence of chronic kidney disease in the community using data from OxRen: A UK population-based cohort study. Br J Gen Pract 2020; 70(693):e285-e293.

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7. Segall L et al. 慢性肾脏疾病患者的心力衰竭:一项系统综合综述. Biomed Res Int 2014; 2014:937398.

8. 美国疾病控制与预防中心. Chronic Kidney Disease in the United States, 2019; 2019 [cited 2020 Oct 1]. Available from: URL: http://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html.

9. Briasoulis A, Bakris GL. 慢性肾脏疾病与冠状动脉疾病风险相当. Current Cardiology Reports 2013; 15(3):340.

10. McMurray JJV et al. 达格列净在心力衰竭和射血分数降低患者中的作用. N Engl J Med 2019; 381(21):1995–2008.