Division of Cardiology (S.T., T.Y., T.W., T.M., Y.F., M.K., A.K., T.K., M.S., M.A., J.N., K.Y., K.K., M.K., K.T., M.F), Osaka General Medical Center, Osaka, Japan.
Department of Diabetes and Endocrinology (K.F., M.H., Y.F., Y.U.), Osaka General Medical Center, Osaka, Japan.
Circ Heart Fail. 2021 Mar;14(3):e007048. doi: 10.1161/CIRCHEARTFAILURE.120.007048. Epub 2021 Mar 5.
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.
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.
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 (=0.040), and hemoconcentration (≥3% absolute increase in hematocrit) was more frequently observed in the empagliflozin group than in the conventional group (=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 (=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.
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.
恩格列净可降低 2 型糖尿病和心血管疾病患者因心力衰竭住院的风险。我们旨在阐明恩格列净作为附加疗法对 2 型糖尿病急性失代偿性心力衰竭患者充血和肾功能的影响。
由于 COVID-19 大流行，该研究提前终止。我们连续纳入 59 例因急性失代偿性心力衰竭入院的 2 型糖尿病患者。患者被随机分为恩格列净附加治疗组（n=30）或常规降糖治疗组（n=29）。我们在基线和随机分组后 1、2、3 和 7 天进行实验室检查。使用 Strauss 公式计算入院时和随后各时间点之间的血浆容量变化百分比。
两组间左心室射血分数和血清 NT-proBNP（N 端脑利钠肽前体）、血细胞比容或血清肌酐水平无显著基线差异。随机分组后 7 天，恩格列净组 NT-proBNP 水平显著低于常规组（=0.040），恩格列净组较常规组更频繁出现血液浓缩（血细胞比容绝对增加≥3%）（=0.020）。与常规组相比，随机分组后 7 天恩格列净组血浆容量变化百分比的下降幅度明显更大（=0.017）。两组间肾功能恶化（血清肌酐增加≥0.3mg/dL）的发生率无显著差异。
在这项探索性分析中，恩格列净作为附加疗法可在 2 型糖尿病合并急性失代偿性心力衰竭患者中实现有效的充血缓解，且不会增加肾功能恶化的风险。注册：网址：https://www.umin.ac.jp/ctr/index.htm；唯一标识符：UMIN000026315。
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