編者按Finerenone（非奈利酮）是拜耳研發的高選擇性鹽皮質激素受體拮抗劑，於2009年12月首次開展心衰適應證的I期臨床研究，之後相繼開始了心衰和糖尿病腎病適應證的II期和III期臨床研究。美國芝加哥大學 George L. Bakris教授團隊牽頭的FIDELIO-DKD研究是一項隨機、雙盲、安慰劑對照、平行組、多中心、事件驅動的III期研究，入組了來自全球48個國家1000多家中心5734例CKD合併2型糖尿病（T2DM）的患者。主要終點是評價Finerenone是否可以減少腎病複合終點事件，關鍵次級終點是評價是否可以減少心血管複合終點事件。本期影片簡單介紹了該臨床研究的結果。
George L. Bakris教授，美國芝加哥大學
中英文字幕
非奈利酮是一種選擇性非類固醇鹽皮質激素受體拮抗劑，在相關慢性腎臟病(CKD)合併T2DM患者的短期試驗中已經證實可以減少蛋白尿。然而，其對腎臟和心血管結局的長期影響尚不清楚。
Finerenone is a selective nonsteroidal mineralocorticoid receptor antagonist that reduced albuminuria in short term trials in patients with chronic kidney disease and type 2 diabetes. But its long term effects on kidney and cardiovascular outcomes are unknown.
在這項雙盲對照研究中，5734例CKD合併T2DM患者按1:1的比例隨機接受非奈利酮或安慰劑治療。
This double blind controlled study, randomized 5734 patients with CKD and type 2 diabetes in a one to one ratio to receive Finerenone or placebo.
主要結局是腎功能衰竭、估計腎小球濾過率自基線持續下降40％以上和腎臟原因死亡。中位隨訪時間為2.6年，非奈利酮治療組2833例患者中有504例發生主要結局事件（17.8%），安慰劑組2841例患者中有600例發生主要結局事件（21.1%）。
The primary composite outcome was time to kidney failure or sustained decrease of at least 40 percent in eGFR from baseline or death from kidney related causes.At a median follow up with 2.6 years, a primary outcome event had occurred in 504 of the 2833 patients, or 17.8% in the Finerenone group, as compared with 600 of 2841 patients, or 21.1% in the placebo group.
關鍵的次級終點是心血管死亡、非致死性心肌梗死、非致死性卒中或因心力衰竭住院，其中非奈利酮組發生率為13.0%，安慰劑組發生率為14.8%。
The key secondary outcome was a time-to-event analysis of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure, which occurred in 13.0% of the Finerenone group as compared with 14.8% of the placebo group.
非奈利酮組中因高鉀血癥而停藥的發生率為2.3%，顯著高於安慰劑組（0.9%）。
Permanent discontinuation of treatment because of hyperkalemia was more frequent with Finerenone than with placebo, 2.3% versus 0.9% .
作者認為，非奈利酮治療CKD合併T2DM的患者，與安慰劑相比，可顯著降低CKD進展和心血管事件的風險。
The authors conclude the treatment with Finerenone resulted in lower risks of disease progression and cardiovascular events than placebo in patients with CKD and type 2 diabetes.
重點詞彙回顧第十期來自idiabetes00:0001:12收錄於話題#精“英”克糖音訊27個
相關單詞學習：
selective nonsteroidal mineralocorticoid receptor antagonist
選擇性非類固醇鹽皮質激素受體拮抗劑
chronic kidney disease
慢性腎臟病
albuminuria /æl,bjʊmɪ'nʊrɪə/
蛋白尿
double blind controlled study
雙盲對照研究
eGFR=estimated glomerular filtration rate
估計腎小球濾過率
Hyperkalemia /,haɪpəke'limiə/
高血鉀症