慢性肾脏病（CKD）是一种严重疾病，患者肾功能呈进行性下降（以eGFR降低或肾脏损害或两者兼有为标志，并持续三个月以上）^{[4]<\/sup>。慢性肾脏病最常见的病因为糖尿病、高血压，以及肾小球肾炎^{[7]<\/sup>。慢性肾脏病患者并发症和心血管事件（如心力衰竭和过早死亡）的发生风险显著增加^{[2]<\/sup>。患者一旦进入慢性肾脏病最严重的阶段，即终末期肾病（ESKD），其肾脏严重受损，肾功能发生进行性恶化，只能通过透析或肾脏移植来维持生命^{[2]<\/sup>。大多数慢性肾脏病患者在进展至终末期肾病之前，会因心血管疾病而死亡^{[8]<\/sup>。目前在中国有高达1.2亿慢性肾脏病患者^{[9]<\/sup>。 <\/p> \n}}}}}}

DAPA-CKD是一项国际多中心、随机、双盲、安慰剂对照III期临床研究，纳入合并或不合并2型糖尿病的慢性肾脏病2-4期尿白蛋白升高患者4,304例，评估达格列净10mg较安慰剂的效果。达格列净在标准治疗的基础上每天给药一次。该研究主要复合终点是肾功能恶化或死亡风险（定义为eGFR下降≥50％，进展至终末期肾病，或心血管或肾病原因导致死亡的复合终点）。次要终点包括肾脏复合终点（eGFR持续下降≥50％，进展至终末期肾病或肾病原因导致的死亡），心血管死亡或因心力衰竭住院的复合终点和全因死亡。该研究在21个国家开展^{[1]<\/sup>，研究结果已发表在《新英格兰医学杂志》上^{[1]<\/sup>。<\/p> \n}}

达格列净是同类首个钠-葡萄糖协同转运蛋白-2（SGLT2）抑制剂，每日口服一次。随着科学研究不断发现心脏，肾脏和胰腺之间的潜在关系，达格列净的研究也从对心肾获益的影响发展到对心肾疾病的预防和器官保护^{[1],[10],[11]<\/sup>。单个器官的受损可导致其他器官功能障碍，这也是世界范围内包括2型糖尿病，心衰和慢性肾脏病在内的主要死亡原因^{[12]-[15]<\/sup>。<\/p> \n}}

根据DECLARE-TIMI 58 III期心血管结局试验结果，达格列净获批用于在饮食和运动基础上改善2型糖尿病成人患者的血糖控制，并在标准治疗（SoC）基础上降低2型糖尿病患者因心力衰竭住院或心血管死亡的风险。^{[11] <\/sup>根据DAPA-HF和DAPA-CKD III期试验结果，达格列净也获批用于治疗射血分数降低型心力衰竭和慢性肾脏病^{[6],[10]<\/sup>。<\/p> \n}}

DapaCare是一项完备的临床试验计划，旨在评估达格列净在心血管、肾脏和器官保护的潜在获益。该计划包括35项已完成和正在进行的IIb \/ III期临床试验，涉及35,000多名患者，并积累了每年超过250万患者年的使用经验。在DAPA-MI III期试验中，达格列净针对不合并2型糖尿病的急性心肌梗死（MI）或心脏病发作的患者进行研究，这是同类研究中首个基于适应症注册登记的随机对照试验^{[16]<\/sup>。<\/p> \n}

心血管、肾脏及代谢一直以来是阿斯利康从全球到中国深耕的重要治疗领域和增长引擎。通过遵循科学以更清楚地了解心脏、肾脏和胰腺之间的潜在联系，阿斯利康积极投身于创新药物的研发，来有效保护器官、减缓疾病进展、降低风险和应对并发症，以改变或停止心血管、肾脏及代谢疾病的自然进程，并可能使器官再生和功能恢复，从根本上改善全球数百万患者的预后，以变革性的科学为患者带来一个更健康的未来。<\/p> \n

阿斯利康（LSE\/STO\/Nasdaq: AZN）是一家科学至上的全球性生物制药企业，专注于研发、生产及营销处方类药品，重点关注肿瘤、包括心血管、肾脏及代谢、呼吸及免疫、疫苗及感染在内的生物制药以及罕见病等领域。阿斯利康全球总部位于英国剑桥，业务遍布世界100多个国家，创新药物惠及全球数百万患者。更多信息，请访问www.astrazeneca.com。<\/p> \n

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[1]. Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436-1446.<\/span><\/p> <\/td> \n <\/tr> \n
[2]. Centers for Disease Control and Prevention (CDC) [Internet]. Chronic kidney disease in the United States; 2019 [cited 2021 Jul 08]. Available from: https:\/\/www.cdc.gov\/kidneydisease\/publications-resources\/2019-national-facts.html<\/a>.<\/span><\/p> <\/td> \n <\/tr> \n
[3]. Segall L, et al. Heart failure in patients with chronic kidney disease: a systematic integrative review. Biomed Res Int. 2014;2014:937398.<\/span><\/p> <\/td> \n <\/tr> \n
[4]. 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. Lancet. 2020;395(10225):709-733.<\/span><\/p> <\/td> \n <\/tr> \n
[5]. Jager KJ, et al. A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Nephrol Dial Transplant. 2019;34(11):1803-1805.<\/span><\/p> <\/td> \n <\/tr> \n
[6]. Heerspink H. DAPA-CKD - Dapagliflozin in Patients with Chronic Kidney Disease. presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 01.<\/span><\/p> <\/td> \n <\/tr> \n
[7]. National Kidney Foundation [Internet]. Kidney Disease: Causes; 2015 [cited 2022 Jun 09]. Available from: <\/span>https:\/\/www.kidney.org\/atoz\/content\/kidneydiscauses<\/a>.<\/span><\/p> <\/td> \n <\/tr> \n
[8]. Briasoulis A, et al. Chronic kidney disease as a coronary artery disease risk equivalent. Curr Cardiol Rep. 2013;15(3):340.<\/span><\/p> <\/td> \n <\/tr> \n
[9]. Zhang L, et al. Lancet. 2012 Mar 3;379(9818)815-22.<\/span><\/p> <\/td> \n <\/tr> \n
[10]. McMurray JJV, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med 2019; 381(21):1995–2008.<\/span><\/p> <\/td> \n <\/tr> \n
[11]. Wiviott SD, et al. for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type-2 diabetes [article and supplementary appendix]. N Engl J Med 2019; 380(4):347–57.<\/span><\/p> <\/td> \n <\/tr> \n
[12]. Vos T, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017; 390(10100):1211–59.<\/span><\/p> <\/td> \n <\/tr> \n
[13]. Mayo Clinic [Internet]. Heart failure, 2020; [cited 2022 Jun 09]. Available from: <\/span>https:\/\/www.mayoclinic.org\/diseases-conditions\/heart-failure\/symptoms-causes\/syc-20373142<\/a>.<\/span><\/p> <\/td> \n <\/tr> \n
[14]. Centers for Disease Control and Prevention (CDC) [Internet]. A snapshot: Diabetes in the United States, 2020; [cited 2022 Jun 09]. Available from: <\/span>https:\/\/www.cdc.gov\/diabetes\/library\/socialmedia\/infographics\/diabetes.html<\/a>.<\/span><\/p> <\/td> \n <\/tr> \n
[15]. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [Internet]. Heart disease & kidney disease, 2016; [cited 2022 Jun 09]. Available from: <\/span>https:\/\/www.niddk.nih.gov\/health-information\/kidney-disease\/heart-disease<\/a>.<\/span><\/p> <\/td> \n <\/tr> \n
[16]. Clinicaltrials.gov [Internet]. Dapagliflozin Effects on Cardiovascular Events in Patients With an Acute Heart Attack (DAPA-MI); [cited 2022 Jun 09]. Available from: <\/span>https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04564742<\/a>.<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n
*<\/i>声明：本文提到的<\/i>DAPA-MI<\/i>研究的适应症仍处于研发阶段，在中国尚未获批。阿斯利康不推荐任何未被批准的药品使用方法。<\/i><\/p> \n
<\/p> \n
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