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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Randomized Controlled Trial of the Hemodynamic Effects of Empagliflozin in Patients With Type 2 Diabetes at High Cardiovascular Risk : The SIMPLE Trial. / Wolsk, Emil; Jürgens, Mikkel; Schou, Morten; Ersbøll, Mads; Hasbak, Philip; Kjær, Andreas; Zerahn, Bo; Brandt, Niels Høgh; Gæde, Peter Haulund; Rossing, Peter; Faber, Jens; Inzucchi, Silvio E.; Kistorp, Caroline Michaela; Gustafsson, Finn.
I: Diabetes, Bind 71, Nr. 4, 2022, s. 812-820.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 - Publisher Copyright: © 2022 by the American Diabetes Association.
PY - 2022
Y1 - 2022
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.
U2 - 10.2337/db21-0721
DO - 10.2337/db21-0721
M3 - Journal article
C2 - 35061894
AN - SCOPUS:85127999939
VL - 71
SP - 812
EP - 820
JO - Diabetes
JF - Diabetes
SN - 0012-1797
IS - 4
ER -
ID: 310420334