前不久，達(dá)格列凈在中國獲批用于降低成人癥狀性慢性心力衰竭（心衰）患者心血管死亡、因心衰住院或心衰緊急就診風(fēng)險。達(dá)格列凈此前已在中國獲批用于治療射血分?jǐn)?shù)降低型心力衰竭（HFrEF），此次獲批意味著達(dá)格列凈已在中國獲批用于降低全射血分?jǐn)?shù)心衰患者的心血管死亡和住院風(fēng)險。

此次中國國家藥品監(jiān)督管理局的批準(zhǔn)是基于DELIVER III期試驗的陽性結(jié)果。DELIVER和DAPA-HF III期試驗預(yù)先指定的匯總分析結(jié)果還證實，達(dá)格列凈是首個在全射血分?jǐn)?shù)范圍內(nèi)降低死亡率的心衰治療藥物。

心衰是一種復(fù)雜的綜合征，當(dāng)心臟無法向全身泵出足夠的血液時就會發(fā)生心衰。中國有約 450萬心衰患者，其中約一半在確診后五年內(nèi)死亡。射血分?jǐn)?shù)高于40%的患者死亡和住院風(fēng)險更高，還有很重的疾病負(fù)擔(dān)且活動受限，導(dǎo)致生活質(zhì)量差。在中國，心衰在醫(yī)療成本和資源利用方面帶來了巨大的經(jīng)濟(jì)負(fù)擔(dān)，而住院是導(dǎo)致心衰治療負(fù)擔(dān)的主要原因——心衰患者的年平均住院時間為30天。

達(dá)格列凈是同類首個人類鈉-葡萄糖協(xié)同轉(zhuǎn)運蛋白2（SGLT2）選擇性抑制劑，每日口服一次。達(dá)格列凈適用于降低癥狀性慢性心衰成人患者心血管死亡、因心衰住院或心衰緊急就診風(fēng)險。達(dá)格列凈目前在中國獲批用于成人慢性腎臟病和在飲食和運動基礎(chǔ)上治療未得到充分控制的2型糖尿病。隨著科學(xué)研究不斷發(fā)現(xiàn)心臟、腎臟和胰腺之間的潛在關(guān)系，研究顯示達(dá)格列凈可有效延緩心腎疾病進(jìn)展，并保護(hù)這些器官。單個器官的受損可導(dǎo)致其他器官功能障礙，這也是全球范圍內(nèi)包括2型糖尿病、心衰和慢性腎臟病在內(nèi)的主要死亡原因。

此前，達(dá)格列凈還在包括中國、日本、美國和歐盟在內(nèi)的全球100多個國家和地區(qū)獲批用于治療成人2型糖尿病、射血分?jǐn)?shù)降低型心衰和慢性腎臟病。

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