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.
Tamaki, Shunsuke MD, PhD; Yamada, Takahisa MD, PhD; Watanabe, Tetsuya MD, PhD; Morita, Takashi MD, PhD; Furukawa, Yoshio MD, PhD; Kawasaki, Masato MD; Kikuchi, Atsushi MD; Kawai, Tsutomu MD; Seo, Masahiro MD; Abe, Makoto MD; Nakamura, Jun MD; Yamamoto, Kyoko MD; Kayama, Kiyomi MD; Kawahira, Masatsugu MD; Tanabe, Kazuya MD; Fujikawa, Kei MD; Hata, Masahisa MD; Fujita, Yohei MD; Umayahara, Yutaka MD, PhD; Taniuchi, Satsuki MS; Sanada, Shoji MD, PhD; Shintani, Ayumi PhD, MPH; Fukunami, Masatake MD, PhD
[Article]
Circulation: Heart Failure.
14(3):e007048, March 2021.
(Format: HTML, PDF)
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.
(C) 2021 American Heart Association, Inc.