前不久，达格列净在中国获批用于降低成人症状性慢性心力衰竭（心衰）患者心血管死亡、因心衰住院或心衰紧急就诊风险。达格列净此前已在中国获批用于治疗射血分数降低型心力衰竭（HFrEF），此次获批意味着达格列净已在中国获批用于降低全射血分数心衰患者的心血管死亡和住院风险。
此次中国国家药品监督管理局的批准是基于DELIVER III期试验的阳性结果。DELIVER和DAPA-HF III期试验预先指定的汇总分析结果还证实，达格列净是首个在全射血分数范围内降低死亡率的心衰治疗药物。
心衰是一种复杂的综合征，当心脏无法向全身泵出足够的血液时就会发生心衰。中国有约 450万心衰患者，其中约一半在确诊后五年内死亡。射血分数高于40%的患者死亡和住院风险更高，还有很重的疾病负担且活动受限，导致生活质量差。在中国，心衰在医疗成本和资源利用方面带来了巨大的经济负担，而住院是导致心衰治疗负担的主要原因——心衰患者的年平均住院时间为30天。
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。达格列净目前在中国获批用于成人慢性肾脏病和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，研究显示达格列净可有效延缓心肾疾病进展，并保护这些器官。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。
此前，达格列净还在包括中国、日本、美国和欧盟在内的全球100多个国家和地区获批用于治疗成人2型糖尿病、射血分数降低型心衰和慢性肾脏病。
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