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Effect of Empagliflozin as an Add-On Therapy on Decongestion and Renal Function in Patients With Diabetes Hospitalized for Acute Decompensated Heart Failure: A Prospective Randomized Controlled Study.

Empagliflozin作为添加疗法对因急性失代偿性心力衰竭住院的糖尿病患者的充血和肾功能的影响: 一项前瞻性随机对照研究。

  • 影响因子:4.83
  • DOI:10.1161/CIRCHEARTFAILURE.120.007048
  • 作者列表:"Tamaki S","Yamada T","Watanabe T","Morita T","Furukawa Y","Kawasaki M","Kikuchi A","Kawai T","Seo M","Abe M","Nakamura J","Yamamoto K","Kayama K","Kawahira M","Tanabe K","Fujikawa K","Hata M","Fujita Y","Umayahara Y","Taniuchi S","Sanada S","Shintani A","Fukunami M
  • 发表时间:2021-03-01
Abstract

BACKGROUND:Empagliflozin reduces the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular disease. We sought to elucidate the effect of empagliflozin as an add-on therapy on decongestion and renal function in patients with type 2 diabetes admitted for acute decompensated heart failure. METHODS:The study was terminated early due to COVID-19 pandemic. We enrolled 59 consecutive patients with type 2 diabetes admitted for acute decompensated heart failure. Patients were randomly assigned to receive either empagliflozin add-on (n=30) or conventional glucose-lowering therapy (n=29). We performed laboratory tests at baseline and 1, 2, 3, and 7 days after randomization. Percent change in plasma volume between admission and subsequent time points was calculated using the Strauss formula. RESULTS:There were no significant baseline differences in left ventricular ejection fraction and serum NT-proBNP (N-terminal pro-B-type natriuretic peptide), hematocrit, or serum creatinine levels between the 2 groups. Seven days after randomization, NT-proBNP level was significantly lower in the empagliflozin group than in the conventional group (P=0.040), and hemoconcentration (≥3% absolute increase in hematocrit) was more frequently observed in the empagliflozin group than in the conventional group (P=0.020). The decrease in percent change in plasma volume between baseline and subsequent time points was significantly larger in the empagliflozin group than in the conventional group 7 days after randomization (P=0.017). The incidence of worsening renal function (an increase in serum creatinine ≥0.3 mg/dL) did not significantly differ between the 2 groups. CONCLUSIONS:In this exploratory analysis, empagliflozin achieved effective decongestion without an increased risk of worsening renal function as an add-on therapy in patients with type 2 diabetes with acute decompensated heart failure. Registration: URL: https://www.umin.ac.jp/ctr/index.htm; Unique identifier: UMIN000026315.

摘要

背景: Empagliflozin可降低2型糖尿病合并心血管疾病患者因心力衰竭住院的风险。我们试图阐明恩格列净作为一种附加疗法对因急性失代偿性心力衰竭入院的2型糖尿病患者的充血和肾功能的影响。 方法: 本研究因新型冠状病毒肺炎大流行提前终止。我们连续纳入了59例因急性失代偿性心力衰竭入院的2型糖尿病患者。患者被随机分配接受empagliflozin添加 (n = 30) 或常规降糖治疗 (n = 29)。我们在基线和随机分组后1、2、3和7天进行了实验室检查.使用Strauss公式计算入院和随后时间点之间血浆体积的百分比变化。 结果: 两组患者的左心室射血分数和血清NT-proBNP (N-末端b型利钠肽前体) 、红细胞压积或血清肌酐水平无显著基线差异。随机分组后7天,empagliflozin组的NT-proBNP水平显著低于常规组 (P = 0.040),empagliflozin组的血液浓缩 (红细胞压积绝对增加 ≥ 3%) 频率高于常规组 (P = 0.020).随机分组后7天,恩格列净组血浆容量变化百分比在基线和后续时间点之间的下降幅度显著大于常规组 (P = 0.017)。肾功能恶化 (血清肌酐升高 ≥ 0.3 mg/dL) 的发生率在2组之间没有显著差异。 结论: 在这项探索性分析中,在合并急性失代偿性心力衰竭的2型糖尿病患者中,empagliflozin在没有增加肾功能恶化风险的情况下实现了有效的降充血。注册: URL: https://www.umin.ac.jp/ctr/index.htm; 唯一标识符: umin000026315.

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影响因子:2.68
发表时间:2021-02-01
DOI:10.1080/14656566.2020.1814255
作者列表:["Sawada H","Oeda T","Kohsaka M","Tomita S","Umemura A","Park K","Yamamoto K","Kiyohara K"]

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DOI:10.1007/s11033-021-06299-9
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