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http://doi.org/10.25358/openscience-9043
Autoren: | Prochaska, Jürgen H. Jünger, Claus Schulz, Andreas Arnold, Natalie Müller, Felix Heidorn, Marc William Baumkötter, Rieke Zahn, Daniela Koeck, Thomas Tröbs, Sven-Oliver Lackner, Karl J. Daiber, Andreas Binder, Harald Shah, Sanjiv J. Gori, Tommaso Münzel, Thomas Wild, Philipp S. |
Titel: | Effects of empagliflozin on left ventricular diastolic function in addition to usual care in individuals with type 2 diabetes mellitus : results from the randomized, double-blind, placebo-controlled EmDia trial |
Online-Publikationsdatum: | 3-Mai-2023 |
Erscheinungsdatum: | 2023 |
Sprache des Dokuments: | Englisch |
Zusammenfassung/Abstract: | Background The sodium-glucose co-transporter 2 inhibitor empagliflozin improves cardiovascular outcome in patients with type 2 diabetes mellitus (T2DM) and heart failure. Experimental studies suggest a direct cardiac effect of empagliflozin associated with an improvement in left ventricular diastolic function. Methods In the randomized, double-blind, two-armed, placebo-controlled, parallel group trial EmDia, patients with T2DM and elevated left ventricular E/E´ ratio were enrolled and randomized 1:1 to receive empagliflozin 10 mg/day versus placebo. The primary endpoint was the change of left ventricular E/E´ ratio after 12 weeks of intervention. Results A total of 144 patients with T2DM and an elevated left ventricular E/e´ ratio (age 68.9 ± 7.7 years; 14.1% women; E/e´ ratio 9.61[8.24/11.14], left ventricular ejection fraction 58.9% ± 5.6%). After 12 weeks of intervention, empagliflozin resulted in a significant higher decrease in the primary endpoint E/e´ ratio by − 1.18 ([95% confidence interval (CI) − 1.72/− 0.65]; P < 0.0001) compared with placebo. The beneficial effect of empagliflozin was consistent across all subgroups and also occurred in subjects with heart failure and preserved ejection fraction (n = 30). Additional effects of empagliflozin on body weight, HbA1c, uric acid, red blood cell count, hemoglobin, mean corpuscular hemoglobin, and hematocrit were detected (all P < 0.001). Approximately one-third of the reduction in E/e´ by empagliflozin could be explained by the variables examined. Conclusions Empagliflozin improves diastolic function in patients with T2DM and elevated end-diastolic pressure. Since the positive effects were consistent in patients with and without heart failure with preserved ejection fraction, the data add a mechanistic insight for the beneficial cardiovascular effect of empagliflozin. Trial registration Clinicaltrials.gov, unique identifier: NCT02932436. |
DDC-Sachgruppe: | 610 Medizin 610 Medical sciences |
Veröffentlichende Institution: | Johannes Gutenberg-Universität Mainz |
Organisationseinheit: | FB 04 Medizin |
Veröffentlichungsort: | Mainz |
ROR: | https://ror.org/023b0x485 |
DOI: | http://doi.org/10.25358/openscience-9043 |
Version: | Published version |
Publikationstyp: | Zeitschriftenaufsatz |
Nutzungsrechte: | CC BY |
Informationen zu den Nutzungsrechten: | https://creativecommons.org/licenses/by/4.0/ |
Zeitschrift: | Clinical research in cardiology Version of Record (VoR) |
Verlag: | Springer |
Verlagsort: | Berlin |
Erscheinungsdatum: | 2023 |
ISSN: | 1861-0692 |
DOI der Originalveröffentlichung: | 10.1007/s00392-023-02164-w |
Enthalten in den Sammlungen: | DFG-491381577-H |
Dateien zu dieser Ressource:
Datei | Beschreibung | Größe | Format | ||
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effects_of_empagliflozin_on_l-20230424121207128.pdf | 1.16 MB | Adobe PDF | Öffnen/Anzeigen |