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Randomized Controlled Trial of the Hemodynamic Effects of Empagliflozin in Patients With Type 2 Diabetes at High Cardiovascular Risk: The SIMPLE Trial

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@article{197148de4d68418ea601df614c8167a5,
title = "Randomized Controlled Trial of the Hemodynamic Effects of Empagliflozin in Patients With Type 2 Diabetes at High Cardiovascular Risk: The SIMPLE Trial",
abstract = "Treatment with the sodium-glucose cotransporter 2 inhibitor (SGLT-2i) empagliflozin significantly reduces cardiovascular events in patients with type 2 diabetes (T2D); however, the mechanisms behind the reduction in cardiovascular (CV) events are unknown. We investigated whether SGLT-2i treatment affected central hemodynamics during rest and exercise in 34 patients with diabetes in this investigator-initiated, randomized, placebo-controlled, double-blinded trial. The primary end point was change in pulmonary capillary wedge pressure (PCWP) at a submaximal ergometer workload (25 W) after 13 weeks of SGLT-2i treatment (25 mg once daily) compared with placebo. Secondary end points included changes in resting hemodynamics. Baseline and follow-up hemodynamic assessments were performed at rest, submaximal exercise (25 W), and peak exercise using right heart catheterization. Treatment with empagliflozin for 13 weeks in patients with T2D at high CV risk did not reduce left heart filling pressure more than placebo at submaximal exercise. At rest, we observed that empagliflozin reduced PCWP at a magnitude of clinical significance.",
keywords = "Benzhydryl Compounds/therapeutic use, Cardiovascular Diseases/etiology, Diabetes Mellitus, Type 2/chemically induced, Glucosides, Heart Disease Risk Factors, Hemodynamics, Humans, Risk Factors, Sodium-Glucose Transporter 2 Inhibitors/pharmacology, Treatment Outcome",
author = "Emil Wolsk and Mikkel J{\"u}rgens and Morten Schou and Mads Ersb{\o}ll and Philip Hasbak and Andreas Kj{\ae}r and Bo Zerahn and Brandt, {Niels H{\o}gh} and G{\ae}de, {Peter Haulund} and Peter Rossing and Jens Faber and Inzucchi, {Silvio E} and Kistorp, {Caroline Michaela} and Finn Gustafsson",
note = "{\textcopyright} 2022 by the American Diabetes Association.",
year = "2022",
month = apr,
day = "1",
doi = "10.2337/db21-0721",
language = "English",
volume = "71",
pages = "812--820",
journal = "Diabetes",
issn = "0012-1797",
publisher = "American Diabetes Association",
number = "4",

}

RIS

TY - JOUR

T1 - Randomized Controlled Trial of the Hemodynamic Effects of Empagliflozin in Patients With Type 2 Diabetes at High Cardiovascular Risk

T2 - The SIMPLE Trial

AU - Wolsk, Emil

AU - Jürgens, Mikkel

AU - Schou, Morten

AU - Ersbøll, Mads

AU - Hasbak, Philip

AU - Kjær, Andreas

AU - Zerahn, Bo

AU - Brandt, Niels Høgh

AU - Gæde, Peter Haulund

AU - Rossing, Peter

AU - Faber, Jens

AU - Inzucchi, Silvio E

AU - Kistorp, Caroline Michaela

AU - Gustafsson, Finn

N1 - © 2022 by the American Diabetes Association.

PY - 2022/4/1

Y1 - 2022/4/1

N2 - Treatment with the sodium-glucose cotransporter 2 inhibitor (SGLT-2i) empagliflozin significantly reduces cardiovascular events in patients with type 2 diabetes (T2D); however, the mechanisms behind the reduction in cardiovascular (CV) events are unknown. We investigated whether SGLT-2i treatment affected central hemodynamics during rest and exercise in 34 patients with diabetes in this investigator-initiated, randomized, placebo-controlled, double-blinded trial. The primary end point was change in pulmonary capillary wedge pressure (PCWP) at a submaximal ergometer workload (25 W) after 13 weeks of SGLT-2i treatment (25 mg once daily) compared with placebo. Secondary end points included changes in resting hemodynamics. Baseline and follow-up hemodynamic assessments were performed at rest, submaximal exercise (25 W), and peak exercise using right heart catheterization. Treatment with empagliflozin for 13 weeks in patients with T2D at high CV risk did not reduce left heart filling pressure more than placebo at submaximal exercise. At rest, we observed that empagliflozin reduced PCWP at a magnitude of clinical significance.

AB - Treatment with the sodium-glucose cotransporter 2 inhibitor (SGLT-2i) empagliflozin significantly reduces cardiovascular events in patients with type 2 diabetes (T2D); however, the mechanisms behind the reduction in cardiovascular (CV) events are unknown. We investigated whether SGLT-2i treatment affected central hemodynamics during rest and exercise in 34 patients with diabetes in this investigator-initiated, randomized, placebo-controlled, double-blinded trial. The primary end point was change in pulmonary capillary wedge pressure (PCWP) at a submaximal ergometer workload (25 W) after 13 weeks of SGLT-2i treatment (25 mg once daily) compared with placebo. Secondary end points included changes in resting hemodynamics. Baseline and follow-up hemodynamic assessments were performed at rest, submaximal exercise (25 W), and peak exercise using right heart catheterization. Treatment with empagliflozin for 13 weeks in patients with T2D at high CV risk did not reduce left heart filling pressure more than placebo at submaximal exercise. At rest, we observed that empagliflozin reduced PCWP at a magnitude of clinical significance.

KW - Benzhydryl Compounds/therapeutic use

KW - Cardiovascular Diseases/etiology

KW - Diabetes Mellitus, Type 2/chemically induced

KW - Glucosides

KW - Heart Disease Risk Factors

KW - Hemodynamics

KW - Humans

KW - Risk Factors

KW - Sodium-Glucose Transporter 2 Inhibitors/pharmacology

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85127999939&partnerID=8YFLogxK

U2 - 10.2337/db21-0721

DO - 10.2337/db21-0721

M3 - Journal article

C2 - 35061894

VL - 71

SP - 812

EP - 820

JO - Diabetes

JF - Diabetes

SN - 0012-1797

IS - 4

ER -

ID: 75904736