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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

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