慢性腎臟病（CKD）是一種嚴重疾病，患者腎功能呈進行性下降（以eGFR降低或腎臟損害或兩者兼有為標志，并持續三個月以上）^{[4]<\/sup>。慢性腎臟病最常見的病因為糖尿病、高血壓，以及腎小球腎炎^{[7]<\/sup>。慢性腎臟病患者并發癥和心血管事件（如心力衰竭和過早死亡）的發生風險顯著增加^{[2]<\/sup>。患者一旦進入慢性腎臟病最嚴重的階段，即終末期腎病（ESKD），其腎臟嚴重受損，腎功能發生進行性惡化，只能通過透析或腎臟移植來維持生命^{[2]<\/sup>。大多數慢性腎臟病患者在進展至終末期腎病之前，會因心血管疾病而死亡^{[8]<\/sup>。目前在中國有高達1.2億慢性腎臟病患者^{[9]<\/sup>。 <\/p> \n}}}}}}

DAPA-CKD是一項國際多中心、隨機、雙盲、安慰劑對照III期臨床研究，納入合并或不合并2型糖尿病的慢性腎臟病2-4期尿白蛋白升高患者4,304例，評估達格列凈10mg較安慰劑的效果。達格列凈在標準治療的基礎上每天給藥一次。該研究主要復合終點是腎功能惡化或死亡風險（定義為eGFR下降≥50％，進展至終末期腎病，或心血管或腎病原因導致死亡的復合終點）。次要終點包括腎臟復合終點（eGFR持續下降≥50％，進展至終末期腎病或腎病原因導致的死亡），心血管死亡或因心力衰竭住院的復合終點和全因死亡。該研究在21個國家開展^{[1]<\/sup>，研究結果已發表在《新英格蘭醫學雜志》上^{[1]<\/sup>。<\/p> \n}}

達格列凈是同類首個鈉-葡萄糖協同轉運蛋白-2（SGLT2）抑制劑，每日口服一次。隨著科學研究不斷發現心臟，腎臟和胰腺之間的潛在關系，達格列凈的研究也從對心腎獲益的影響發展到對心腎疾病的預防和器官保護^{[1],[10],[11]<\/sup>。單個器官的受損可導致其他器官功能障礙，這也是世界范圍內包括2型糖尿病，心衰和慢性腎臟病在內的主要死亡原因^{[12]-[15]<\/sup>。<\/p> \n}}

根據DECLARE-TIMI 58 III期心血管結局試驗結果，達格列凈獲批用于在飲食和運動基礎上改善2型糖尿病成人患者的血糖控制，并在標準治療（SoC）基礎上降低2型糖尿病患者因心力衰竭住院或心血管死亡的風險。^{[11] <\/sup>根據DAPA-HF和DAPA-CKD III期試驗結果，達格列凈也獲批用于治療射血分數降低型心力衰竭和慢性腎臟病^{[6],[10]<\/sup>。<\/p> \n}}

DapaCare是一項完備的臨床試驗計劃，旨在評估達格列凈在心血管、腎臟和器官保護的潛在獲益。該計劃包括35項已完成和正在進行的IIb \/ III期臨床試驗，涉及35,000多名患者，并積累了每年超過250萬患者年的使用經驗。在DAPA-MI III期試驗中，達格列凈針對不合并2型糖尿病的急性心肌梗死（MI）或心臟病發作的患者進行研究，這是同類研究中首個基于適應癥注冊登記的隨機對照試驗^{[16]<\/sup>。<\/p> \n}

心血管、腎臟及代謝一直以來是阿斯利康從全球到中國深耕的重要治療領域和增長引擎。通過遵循科學以更清楚地了解心臟、腎臟和胰腺之間的潛在聯系，阿斯利康積極投身于創新藥物的研發，來有效保護器官、減緩疾病進展、降低風險和應對并發癥，以改變或停止心血管、腎臟及代謝疾病的自然進程，并可能使器官再生和功能恢復，從根本上改善全球數百萬患者的預后，以變革性的科學為患者帶來一個更健康的未來。<\/p> \n

阿斯利康（LSE\/STO\/Nasdaq: AZN）是一家科學至上的全球性生物制藥企業，專注于研發、生產及營銷處方類藥品，重點關注腫瘤、包括心血管、腎臟及代謝、呼吸及免疫、疫苗及感染在內的生物制藥以及罕見病等領域。阿斯利康全球總部位于英國劍橋，業務遍布世界100多個國家，創新藥物惠及全球數百萬患者。更多信息，請訪問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>聲明：本文提到的<\/i>DAPA-MI<\/i>研究的適應癥仍處于研發階段，在中國尚未獲批。阿斯利康不推薦任何未被批準的藥品使用方法。<\/i><\/p> \n
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