Effects of Early Empagliflozin Initiation on Diuresis and Kidney Function in Patients With Acute Decompensated Heart Failure (EMPAG-HF)

Effective diuretic regimens using loop diuretics in patients with acute decompensated heart failure are often limited by the development of worsening kidney function. Sodium-glucose cotransporter-2 inhibitors induce glucosuria and sodium excretion with nephroprotective effects in patients with stabl...

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Vydáno v:	Circulation (New York, N.Y.) Ročník 146; číslo 4; s. 289
Hlavní autoři:	Schulze, P Christian, Bogoviku, Jürgen, Westphal, Julian, Aftanski, Pawel, Haertel, Franz, Grund, Sissy, von Haehling, Stephan, Schumacher, Ulrike, Möbius-Winkler, Sven, Busch, Martin
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States 26.07.2022
Témata:	Benzhydryl Compounds Creatinine Diuresis Diuretics - adverse effects Glucosides Heart Failure - complications Heart Failure - diagnosis Heart Failure - drug therapy Humans Kidney Prospective Studies Sodium - urine Sodium Potassium Chloride Symporter Inhibitors - adverse effects Sodium-Glucose Transporter 2 Inhibitors - adverse effects heart failure kidney diuretics
ISSN:	1524-4539, 1524-4539
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Abstract	Effective diuretic regimens using loop diuretics in patients with acute decompensated heart failure are often limited by the development of worsening kidney function. Sodium-glucose cotransporter-2 inhibitors induce glucosuria and sodium excretion with nephroprotective effects in patients with stable heart failure but their role in acute decompensated heart failure is unclear. In this single-center, prospective, double-blind, placebo-controlled, randomized study, we randomly assigned patients with acute decompensated heart failure to empagliflozin 25 mg daily or placebo in addition to standard decongestive treatments that included loop diuretics. The primary end point was cumulative urine output over 5 days. Secondary end points included diuretic efficiency, dynamics in markers of kidney function and injury, and NT-proBNP (N-terminal pro-B-type natriuretic peptide). Sixty patients were randomized within 12 hours of hospitalization for acute decompensated heart failure. Addition of empagliflozin daily to standard medical treatment of acute decompensated heart failure resulted in a 25% increase in cumulative urine output over 5 days (median 10.8 versus 8.7 L mL in placebo, group difference estimation 2.2 L [95% CI, 8.4 to 3.6]; =0.003). Empagliflozin increased diuretic efficiency compared with placebo (14.1 mL urine per milligram furosemide equivalent [95% CI, 0.6-27.7]; =0.041) without affecting markers of renal function (estimated glomerular filtration rate, 51±19 versus 54±17 mL/min per 1.73 m²; =0.599) or injury (total urinary protein, 492±845 versus 503±847 mg/g creatinine; =0.975; and urinary α1-microglobulin, 55.4±38.6 versus 31.3±33.6 mg/g creatinine; =0.066) with more pronounced decrease in NT-proBNP in the empagliflozin group compared with placebo (-1861 versus -727.2 pg/mL after 5 days; quotient in slope, 0.89 [95% CI, 0.83-0.95]; <0.001). There were no differences in the incidence of safety events between groups. Early addition of empagliflozin to standard diuretic therapy increases urine output without affecting renal function in patients with acute decompensated heart failure. URL: https://www. gov; Unique identifier: NCT04049045.
AbstractList	Effective diuretic regimens using loop diuretics in patients with acute decompensated heart failure are often limited by the development of worsening kidney function. Sodium-glucose cotransporter-2 inhibitors induce glucosuria and sodium excretion with nephroprotective effects in patients with stable heart failure but their role in acute decompensated heart failure is unclear. In this single-center, prospective, double-blind, placebo-controlled, randomized study, we randomly assigned patients with acute decompensated heart failure to empagliflozin 25 mg daily or placebo in addition to standard decongestive treatments that included loop diuretics. The primary end point was cumulative urine output over 5 days. Secondary end points included diuretic efficiency, dynamics in markers of kidney function and injury, and NT-proBNP (N-terminal pro-B-type natriuretic peptide). Sixty patients were randomized within 12 hours of hospitalization for acute decompensated heart failure. Addition of empagliflozin daily to standard medical treatment of acute decompensated heart failure resulted in a 25% increase in cumulative urine output over 5 days (median 10.8 versus 8.7 L mL in placebo, group difference estimation 2.2 L [95% CI, 8.4 to 3.6]; =0.003). Empagliflozin increased diuretic efficiency compared with placebo (14.1 mL urine per milligram furosemide equivalent [95% CI, 0.6-27.7]; =0.041) without affecting markers of renal function (estimated glomerular filtration rate, 51±19 versus 54±17 mL/min per 1.73 m²; =0.599) or injury (total urinary protein, 492±845 versus 503±847 mg/g creatinine; =0.975; and urinary α1-microglobulin, 55.4±38.6 versus 31.3±33.6 mg/g creatinine; =0.066) with more pronounced decrease in NT-proBNP in the empagliflozin group compared with placebo (-1861 versus -727.2 pg/mL after 5 days; quotient in slope, 0.89 [95% CI, 0.83-0.95]; <0.001). There were no differences in the incidence of safety events between groups. Early addition of empagliflozin to standard diuretic therapy increases urine output without affecting renal function in patients with acute decompensated heart failure. URL: https://www. gov; Unique identifier: NCT04049045. Effective diuretic regimens using loop diuretics in patients with acute decompensated heart failure are often limited by the development of worsening kidney function. Sodium-glucose cotransporter-2 inhibitors induce glucosuria and sodium excretion with nephroprotective effects in patients with stable heart failure but their role in acute decompensated heart failure is unclear.BACKGROUNDEffective diuretic regimens using loop diuretics in patients with acute decompensated heart failure are often limited by the development of worsening kidney function. Sodium-glucose cotransporter-2 inhibitors induce glucosuria and sodium excretion with nephroprotective effects in patients with stable heart failure but their role in acute decompensated heart failure is unclear.In this single-center, prospective, double-blind, placebo-controlled, randomized study, we randomly assigned patients with acute decompensated heart failure to empagliflozin 25 mg daily or placebo in addition to standard decongestive treatments that included loop diuretics. The primary end point was cumulative urine output over 5 days. Secondary end points included diuretic efficiency, dynamics in markers of kidney function and injury, and NT-proBNP (N-terminal pro-B-type natriuretic peptide).METHODSIn this single-center, prospective, double-blind, placebo-controlled, randomized study, we randomly assigned patients with acute decompensated heart failure to empagliflozin 25 mg daily or placebo in addition to standard decongestive treatments that included loop diuretics. The primary end point was cumulative urine output over 5 days. Secondary end points included diuretic efficiency, dynamics in markers of kidney function and injury, and NT-proBNP (N-terminal pro-B-type natriuretic peptide).Sixty patients were randomized within 12 hours of hospitalization for acute decompensated heart failure. Addition of empagliflozin daily to standard medical treatment of acute decompensated heart failure resulted in a 25% increase in cumulative urine output over 5 days (median 10.8 versus 8.7 L mL in placebo, group difference estimation 2.2 L [95% CI, 8.4 to 3.6]; P=0.003). Empagliflozin increased diuretic efficiency compared with placebo (14.1 mL urine per milligram furosemide equivalent [95% CI, 0.6-27.7]; P=0.041) without affecting markers of renal function (estimated glomerular filtration rate, 51±19 versus 54±17 mL/min per 1.73 m²; P=0.599) or injury (total urinary protein, 492±845 versus 503±847 mg/g creatinine; P=0.975; and urinary α1-microglobulin, 55.4±38.6 versus 31.3±33.6 mg/g creatinine; P=0.066) with more pronounced decrease in NT-proBNP in the empagliflozin group compared with placebo (-1861 versus -727.2 pg/mL after 5 days; quotient in slope, 0.89 [95% CI, 0.83-0.95]; P<0.001). There were no differences in the incidence of safety events between groups.RESULTSSixty patients were randomized within 12 hours of hospitalization for acute decompensated heart failure. Addition of empagliflozin daily to standard medical treatment of acute decompensated heart failure resulted in a 25% increase in cumulative urine output over 5 days (median 10.8 versus 8.7 L mL in placebo, group difference estimation 2.2 L [95% CI, 8.4 to 3.6]; P=0.003). Empagliflozin increased diuretic efficiency compared with placebo (14.1 mL urine per milligram furosemide equivalent [95% CI, 0.6-27.7]; P=0.041) without affecting markers of renal function (estimated glomerular filtration rate, 51±19 versus 54±17 mL/min per 1.73 m²; P=0.599) or injury (total urinary protein, 492±845 versus 503±847 mg/g creatinine; P=0.975; and urinary α1-microglobulin, 55.4±38.6 versus 31.3±33.6 mg/g creatinine; P=0.066) with more pronounced decrease in NT-proBNP in the empagliflozin group compared with placebo (-1861 versus -727.2 pg/mL after 5 days; quotient in slope, 0.89 [95% CI, 0.83-0.95]; P<0.001). There were no differences in the incidence of safety events between groups.Early addition of empagliflozin to standard diuretic therapy increases urine output without affecting renal function in patients with acute decompensated heart failure.CONCLUSIONSEarly addition of empagliflozin to standard diuretic therapy increases urine output without affecting renal function in patients with acute decompensated heart failure.URL: https://www.REGISTRATIONURL: https://www.gov; Unique identifier: NCT04049045.CLINICALTRIALSgov; Unique identifier: NCT04049045.
Author	Möbius-Winkler, Sven Busch, Martin Schulze, P Christian Grund, Sissy von Haehling, Stephan Westphal, Julian Schumacher, Ulrike Aftanski, Pawel Haertel, Franz Bogoviku, Jürgen
Author_xml	– sequence: 1 givenname: P Christian orcidid: 0000-0001-9442-7141 surname: Schulze fullname: Schulze, P Christian organization: Department of Internal Medicine I, Division of Cardiology, Angiology and Intensive Medical Care (P.C.S., J.B., J.W., P.A., F.H., S.G., S.M.-W.), Friedrich-Schiller-University, University Hospital Jena, Germany – sequence: 2 givenname: Jürgen surname: Bogoviku fullname: Bogoviku, Jürgen organization: Department of Internal Medicine I, Division of Cardiology, Angiology and Intensive Medical Care (P.C.S., J.B., J.W., P.A., F.H., S.G., S.M.-W.), Friedrich-Schiller-University, University Hospital Jena, Germany – sequence: 3 givenname: Julian orcidid: 0000-0002-7488-4000 surname: Westphal fullname: Westphal, Julian organization: Department of Internal Medicine I, Division of Cardiology, Angiology and Intensive Medical Care (P.C.S., J.B., J.W., P.A., F.H., S.G., S.M.-W.), Friedrich-Schiller-University, University Hospital Jena, Germany – sequence: 4 givenname: Pawel surname: Aftanski fullname: Aftanski, Pawel organization: Department of Internal Medicine I, Division of Cardiology, Angiology and Intensive Medical Care (P.C.S., J.B., J.W., P.A., F.H., S.G., S.M.-W.), Friedrich-Schiller-University, University Hospital Jena, Germany – sequence: 5 givenname: Franz surname: Haertel fullname: Haertel, Franz organization: Department of Internal Medicine I, Division of Cardiology, Angiology and Intensive Medical Care (P.C.S., J.B., J.W., P.A., F.H., S.G., S.M.-W.), Friedrich-Schiller-University, University Hospital Jena, Germany – sequence: 6 givenname: Sissy surname: Grund fullname: Grund, Sissy organization: Department of Internal Medicine I, Division of Cardiology, Angiology and Intensive Medical Care (P.C.S., J.B., J.W., P.A., F.H., S.G., S.M.-W.), Friedrich-Schiller-University, University Hospital Jena, Germany – sequence: 7 givenname: Stephan surname: von Haehling fullname: von Haehling, Stephan organization: German Center for Cardiovascular Research (DZHK), partner site Göttingen, Germany (S.v.H.) – sequence: 8 givenname: Ulrike surname: Schumacher fullname: Schumacher, Ulrike organization: Center for Clinical Studies (U.S.), Friedrich-Schiller-University, University Hospital Jena, Germany – sequence: 9 givenname: Sven orcidid: 0000-0003-1319-6738 surname: Möbius-Winkler fullname: Möbius-Winkler, Sven organization: Department of Internal Medicine I, Division of Cardiology, Angiology and Intensive Medical Care (P.C.S., J.B., J.W., P.A., F.H., S.G., S.M.-W.), Friedrich-Schiller-University, University Hospital Jena, Germany – sequence: 10 givenname: Martin surname: Busch fullname: Busch, Martin organization: Department of Internal Medicine III, Division of Nephrology (M.B.), Friedrich-Schiller-University, University Hospital Jena, Germany
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SubjectTerms	Benzhydryl Compounds Creatinine Diuresis Diuretics - adverse effects Glucosides Heart Failure - complications Heart Failure - diagnosis Heart Failure - drug therapy Humans Kidney Prospective Studies Sodium - urine Sodium Potassium Chloride Symporter Inhibitors - adverse effects Sodium-Glucose Transporter 2 Inhibitors - adverse effects
Title	Effects of Early Empagliflozin Initiation on Diuresis and Kidney Function in Patients With Acute Decompensated Heart Failure (EMPAG-HF)
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