圖注：Finerenone作用機(jī)制

 

　　Finerenone III期臨床項(xiàng)目是迄今為止最大的CKD III期臨床項(xiàng)目。該項(xiàng)目由兩項(xiàng)研究組成，入組了全球各地1.3萬例伴有廣泛嚴(yán)重程度CKD疾病的T2D患者，包括早期腎損害和更晚期腎病的患者。該項(xiàng)目旨在評(píng)估Finerenone與安慰劑分別聯(lián)合標(biāo)準(zhǔn)護(hù)理對(duì)腎臟和心血管（CV）預(yù)后的影響。

 

　　FIDELIO-DKD（Finerenone降低糖尿病腎病腎衰竭和疾病進(jìn)展）是一項(xiàng)隨機(jī)、雙盲、安慰劑對(duì)照、平行組、多中心、事件驅(qū)動(dòng)的III期研究，入組了來自全球48個(gè)國家1000多個(gè)地點(diǎn)的約5700例伴有CKD的T2D患者。研究中，這些患者被隨機(jī)分配，接受每天一次口服10mg或20mg的Finerenone或安慰劑，同時(shí)接受標(biāo)準(zhǔn)護(hù)理，包括降糖治療和最大耐受劑量的腎素-血管緊張素系統(tǒng)（RAS）阻斷劑，如血管緊張素轉(zhuǎn)換酶（ACE）抑制劑或血管緊張素II受體阻滯劑（ARB）。該研究已經(jīng)達(dá)到了主要終點(diǎn)。

 

　　FIGARO-DKD（Finerenone降低糖尿病腎病心血管病發(fā)病率和死亡）研究仍在進(jìn)行中，該研究在歐洲、日本、中國、美國等48個(gè)國家入組了約7400例伴有CKD的T2D患者。

 

　　拜耳最近宣布啟動(dòng)FINEARTS-HF研究，這是一項(xiàng)多中心、隨機(jī)、雙盲、安慰劑對(duì)照III期研究，將在超過5500例左心室射血分?jǐn)?shù)≥40%的有癥狀心力衰竭（HF）患者（紐約心臟協(xié)會(huì)II-IV級(jí)）中調(diào)查Finerenone與安慰劑。

 

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