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Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction: A double-blinded, randomized, and placebo-controlled trial

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Jensen, Jesper ; Omar, Massar ; Kistorp, Caroline ; Poulsen, Mikael Kjær ; Tuxen, Christian ; Gustafsson, Ida ; Køber, Lars ; Gustafsson, Finn ; Faber, Jens ; Fosbøl, Emil L ; Bruun, Niels Eske ; Brønd, Jan Christian ; Forman, Julie Lyng ; Videbæk, Lars ; Møller, Jacob Eifer ; Schou, Morten. / Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction : A double-blinded, randomized, and placebo-controlled trial. In: American Heart Journal. 2020 ; Vol. 228. pp. 47-56.

Bibtex

@article{2fed164f2f544648b6ac10c5a99db661,
title = "Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction: A double-blinded, randomized, and placebo-controlled trial",
abstract = "AIMS: To investigate the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on N-terminal pro-b-type natriuretic peptide (NT-proBNP) in patients with heart failure (HF) and reduced ejection fraction (HFrEF).METHODS AND RESULTS: Empire HF was an investigator-initiated, multi-center, double-blinded, placebo-controlled, randomized trial. Patients with mildly symptomatic HFrEF, mean (standard deviation (SD)) age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy were assigned to receive either empagliflozin 10 mg once daily or placebo for 12 weeks. The primary endpoint was the between-group difference in the change of NT-proBNP from baseline to 12 weeks. In total, 95 patients were assigned to empagliflozin and 95 to placebo. No significant difference in the change of NT-proBNP with empagliflozin versus placebo was observed [Empagliflozin: baseline, median (interquartile range (IQR)) 582 (304-1020) pg/mL, 12 weeks, 478 (281-961) pg/mL; Placebo: baseline, 605 (322-1070) pg/mL, 12 weeks, 520 (267-1075) pg/mL, adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7]. Further, no significant difference was observed in accelerometer-measured daily activity level [adjusted mean difference of change, empagliflozin versus placebo, -26.0 accelerometer counts; 95% CI -88.0 to 36.0, P = 0.4] or Kansas City Cardiomyopathy Questionnaire Overall Summary Score [adjusted mean difference of change, empagliflozin versus placebo 0.8; 95% CI -2.3 to 3.9, P = 0.6].CONCLUSION: In low-risk patients with HFrEF with mild symptoms and on recommended HF therapy, empagliflozin did not change NT-proBNP after 12 weeks. Further, no change in daily activity level or health status was observed.",
keywords = "Accelerometry/methods, Activities of Daily Living, Benzhydryl Compounds/administration & dosage, Double-Blind Method, Female, Glucosides/administration & dosage, Heart Failure/blood, Humans, Male, Middle Aged, Natriuretic Peptide, Brain/blood, Outcome Assessment, Health Care, Peptide Fragments/blood, Sodium-Glucose Transporter 2 Inhibitors/administration & dosage, Stroke Volume, Ventricular Dysfunction, Left/diagnosis",
author = "Jesper Jensen and Massar Omar and Caroline Kistorp and Poulsen, {Mikael Kj{\ae}r} and Christian Tuxen and Ida Gustafsson and Lars K{\o}ber and Finn Gustafsson and Jens Faber and Fosb{\o}l, {Emil L} and Bruun, {Niels Eske} and Br{\o}nd, {Jan Christian} and Forman, {Julie Lyng} and Lars Videb{\ae}k and M{\o}ller, {Jacob Eifer} and Morten Schou",
note = "Copyright {\textcopyright} 2020 The Authors. Published by Elsevier Inc. All rights reserved.",
year = "2020",
month = oct,
doi = "10.1016/j.ahj.2020.07.011",
language = "English",
volume = "228",
pages = "47--56",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby, Inc",

}

RIS

TY - JOUR

T1 - Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction

T2 - A double-blinded, randomized, and placebo-controlled trial

AU - Jensen, Jesper

AU - Omar, Massar

AU - Kistorp, Caroline

AU - Poulsen, Mikael Kjær

AU - Tuxen, Christian

AU - Gustafsson, Ida

AU - Køber, Lars

AU - Gustafsson, Finn

AU - Faber, Jens

AU - Fosbøl, Emil L

AU - Bruun, Niels Eske

AU - Brønd, Jan Christian

AU - Forman, Julie Lyng

AU - Videbæk, Lars

AU - Møller, Jacob Eifer

AU - Schou, Morten

N1 - Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

PY - 2020/10

Y1 - 2020/10

N2 - AIMS: To investigate the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on N-terminal pro-b-type natriuretic peptide (NT-proBNP) in patients with heart failure (HF) and reduced ejection fraction (HFrEF).METHODS AND RESULTS: Empire HF was an investigator-initiated, multi-center, double-blinded, placebo-controlled, randomized trial. Patients with mildly symptomatic HFrEF, mean (standard deviation (SD)) age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy were assigned to receive either empagliflozin 10 mg once daily or placebo for 12 weeks. The primary endpoint was the between-group difference in the change of NT-proBNP from baseline to 12 weeks. In total, 95 patients were assigned to empagliflozin and 95 to placebo. No significant difference in the change of NT-proBNP with empagliflozin versus placebo was observed [Empagliflozin: baseline, median (interquartile range (IQR)) 582 (304-1020) pg/mL, 12 weeks, 478 (281-961) pg/mL; Placebo: baseline, 605 (322-1070) pg/mL, 12 weeks, 520 (267-1075) pg/mL, adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7]. Further, no significant difference was observed in accelerometer-measured daily activity level [adjusted mean difference of change, empagliflozin versus placebo, -26.0 accelerometer counts; 95% CI -88.0 to 36.0, P = 0.4] or Kansas City Cardiomyopathy Questionnaire Overall Summary Score [adjusted mean difference of change, empagliflozin versus placebo 0.8; 95% CI -2.3 to 3.9, P = 0.6].CONCLUSION: In low-risk patients with HFrEF with mild symptoms and on recommended HF therapy, empagliflozin did not change NT-proBNP after 12 weeks. Further, no change in daily activity level or health status was observed.

AB - AIMS: To investigate the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on N-terminal pro-b-type natriuretic peptide (NT-proBNP) in patients with heart failure (HF) and reduced ejection fraction (HFrEF).METHODS AND RESULTS: Empire HF was an investigator-initiated, multi-center, double-blinded, placebo-controlled, randomized trial. Patients with mildly symptomatic HFrEF, mean (standard deviation (SD)) age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy were assigned to receive either empagliflozin 10 mg once daily or placebo for 12 weeks. The primary endpoint was the between-group difference in the change of NT-proBNP from baseline to 12 weeks. In total, 95 patients were assigned to empagliflozin and 95 to placebo. No significant difference in the change of NT-proBNP with empagliflozin versus placebo was observed [Empagliflozin: baseline, median (interquartile range (IQR)) 582 (304-1020) pg/mL, 12 weeks, 478 (281-961) pg/mL; Placebo: baseline, 605 (322-1070) pg/mL, 12 weeks, 520 (267-1075) pg/mL, adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7]. Further, no significant difference was observed in accelerometer-measured daily activity level [adjusted mean difference of change, empagliflozin versus placebo, -26.0 accelerometer counts; 95% CI -88.0 to 36.0, P = 0.4] or Kansas City Cardiomyopathy Questionnaire Overall Summary Score [adjusted mean difference of change, empagliflozin versus placebo 0.8; 95% CI -2.3 to 3.9, P = 0.6].CONCLUSION: In low-risk patients with HFrEF with mild symptoms and on recommended HF therapy, empagliflozin did not change NT-proBNP after 12 weeks. Further, no change in daily activity level or health status was observed.

KW - Accelerometry/methods

KW - Activities of Daily Living

KW - Benzhydryl Compounds/administration & dosage

KW - Double-Blind Method

KW - Female

KW - Glucosides/administration & dosage

KW - Heart Failure/blood

KW - Humans

KW - Male

KW - Middle Aged

KW - Natriuretic Peptide, Brain/blood

KW - Outcome Assessment, Health Care

KW - Peptide Fragments/blood

KW - Sodium-Glucose Transporter 2 Inhibitors/administration & dosage

KW - Stroke Volume

KW - Ventricular Dysfunction, Left/diagnosis

UR - http://www.scopus.com/inward/record.url?scp=85089349743&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2020.07.011

DO - 10.1016/j.ahj.2020.07.011

M3 - Journal article

C2 - 32798787

VL - 228

SP - 47

EP - 56

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -

ID: 61379432