心力衰竭是一种长期的慢性疾病，会随着时间推移而恶化^{[8]<\/sup>。心衰影响全球约6400万人^{[9]<\/sup>，具有高发病率及死亡率^{[10]<\/sup>。慢性心衰是导致65岁以上患者住院的主要原因，带来巨大的临床负担和经济负担^{[11]<\/sup>。心衰根据左心室射血分数（LVEF），即心脏每次收缩时从心脏泵出血液的百分比可分为：射血分数降低型心衰（LVEF≤40%）、射血分数轻度降低型心衰（LVEF在41%至49%之间）和射血分数保留型心衰（LVEF≥50%）^{[12]<\/sup>。所有心衰患者中有约一半为射血分数轻度降低或保留型心衰，但其可选择的治疗方式很少^{[13]<\/sup>。<\/p> \n}}}}}}

DELIVER（评估达格列净改善射血分数保留心力衰竭患者生活的疗效）是一项国际性的、随机、双盲、平行分组、安慰剂对照、事件驱动的III期试验，旨在评估与安慰剂相比，达格列净在治疗左心室射血分数高于40%的心衰患者的疗效，不论其是否合并2型糖尿病。DELIVER是迄今在射血分数大于40%的心衰患者中开展的最大的临床试验，共有6263名患者随机入组^{[14]<\/sup>。DELIVER III期试验的结果显示在总体研究人群中，达格列净在降低CV死亡或HF事件的主要复合终点发生率方面优于安慰剂，相对风险降低了18%（95% CI 8%，27%），并且复合终点的所有组分均对疗效有所贡献。<\/p> \n}

DAPA-HF（达格列净预防心力衰竭的不良结局）是一项国际、多中心、平行分组、随机、双盲的III期临床试验，入选了4744例射血分数降低型心衰患者，不论其合并或不合并2型糖尿病。该试验旨在评估与安慰剂相比，在标准治疗基础上加用达格列净 10mg每日一次的疗效。主要复合终点是首次出现心衰恶化事件（住院或同等事件，如心衰紧急就诊）或心血管死亡。中位随访时间为18.2个月^{[15]<\/sup>。关键次要终点包括因心衰住院（包括再次入院）和心血管死亡的总数，堪萨斯城心肌病问卷（KCCQ）总症状评分在8个月间与基线相比的变化^{[15]<\/sup>。<\/p> \n}}

达格列净是同类首个人类钠-葡萄糖协同转运蛋白2（SGLT2）选择性抑制剂，每日口服一次。达格列净适用于降低症状性慢性心衰成人患者心血管死亡、因心衰住院或心衰紧急就诊风险^{[16]<\/sup>。达格列净在中国获批用于成人慢性肾脏病，在饮食和运动基础上治疗未得到充分控制的2型糖尿病。随着科学研究不断发现心脏，肾脏和胰腺之间的潜在关系，研究也显示出达格列净在延缓心肾疾病以及器官保护方面的疗效^{[15],[17]-[18]<\/sup>。单个器官的受损可导致其他器官功能障碍，这也是全球范围内包括2型糖尿病、心衰和慢性肾脏病在内的主要死亡原因^{[3],[9],[19]-[20]<\/sup>。<\/p> \n}}}

心血管、肾脏及代谢始终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

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^{[2]<\/sup>.      Solomon S, et al. Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med<\/i>. 2022; 387(12):1089-1098.<\/span><\/p> <\/td> \n <\/tr> \n}
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^{[4]<\/sup>.      Guo Y, et al. Heart Failure in East Asia. Current Cardiology Reviews<\/i>. 2013;9:112-122.<\/span><\/p> <\/td> \n <\/tr> \n}
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^{[9]<\/sup>.      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.<\/i> 2017;390(10100):1211-1259.<\/span><\/p> <\/td> \n <\/tr> \n}
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^{[11]<\/sup>.    McDonagh T, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J.<\/i> 2021;00:1-128.<\/span><\/p> <\/td> \n <\/tr> \n}
^{[12]<\/sup>.    Heidenreich PA, et al. 2022 AHA\/ACC\/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology\/American Heart Association Joint Committee on Clinical Practice Guidelines. Journal of American College of Cardiology. <\/i>2008;10(10):933-989.<\/span><\/p> <\/td> \n <\/tr> \n}
^{[13]<\/sup>.    Kosiborod MN, et al. The effects of dapagliflozin on symptoms, function and quality of life in patients with heart failure and mildly reduced or preserved ejection fraction: results from the DELIVER Trial. Presented at: American Heart Association (AHA) Scientific Sessions<\/i> 2022, 5-7 November 2022, Chicago, Illinois, USA.<\/span><\/p> <\/td> \n <\/tr> \n}
^{[14]<\/sup>.    Solomon SD, et al. Dapagliflozin in heart failure with preserved and mildly reduced ejection fraction: rationale and design of the DELIVER trial. Eur J Heart Fail.<\/i> 2021;23(7):1217-1225.<\/span><\/p> <\/td> \n <\/tr> \n}
^{[15]<\/sup>.    McMurray JJV, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med.<\/i> 2019;381(21):1995-2008.<\/span><\/p> <\/td> \n <\/tr> \n}
^{[16]<\/sup>.    Forxiga Prescribing Information.<\/span><\/p> <\/td> \n <\/tr> \n}
^{[17]<\/sup>.    Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med<\/i>. 2020;383(15):1436-1446. <\/span><\/p> <\/td> \n <\/tr> \n}
^{[18]<\/sup>.    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<\/i>. 2019;380(4):347-357.<\/span><\/p> <\/td> \n <\/tr> \n}
^{[19]<\/sup>.    Centers for Disease Control and Prevention (CDC) [Internet]. A snapshot: Diabetes in the United States; [cited 2023 Aug 1]. Available from: https:\/\/www.cdc.gov\/diabetes\/library\/socialmedia\/infographics\/diabetes.html<\/a>.<\/span><\/p> <\/td> \n <\/tr> \n}
^{[20]<\/sup>.    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [Internet]. Heart disease & kidney disease; [cited 2023 Aug 1]. Available from: https:\/\/www.niddk.nih.gov\/health-information\/kidney-disease\/heart-disease<\/a>.<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div>"];
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