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

Emil Wolsk*, Mikkel Jürgens, Morten Schou, Mads Ersbøll, Philip Hasbak, Andreas Kjær, Bo Zerahn, Niels Høgh Brandt, Peter Haulund Gæde, Peter Rossing, Jens Faber, Silvio E Inzucchi, Caroline Michaela Kistorp, Finn Gustafsson

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

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.

Original languageEnglish
Pages (from-to)812-820
Number of pages9
JournalDiabetes
Volume71
Issue number4
Early online date21 Jan 2022
DOIs
Publication statusPublished - 1 Apr 2022

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© 2022 by the American Diabetes Association.

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