Article ; Online: 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.
Clinical research in cardiology : official journal of the German Cardiac Society
2023 Volume 112, Issue 7, Page(s) 911–922
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 ... ...
| 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. |
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| MeSH term(s) | Humans ; Female ; Middle Aged ; Aged ; Male ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/diagnosis ; Diabetes Mellitus, Type 2/drug therapy ; Ventricular Function, Left ; Stroke Volume ; Treatment Outcome ; Sodium-Glucose Transporter 2 Inhibitors/adverse effects ; Double-Blind Method ; Heart Failure/diagnosis ; Heart Failure/drug therapy ; Heart Failure/complications |
| Chemical Substances | empagliflozin (HDC1R2M35U) ; Sodium-Glucose Transporter 2 Inhibitors |
| Language | English |
| Publishing date | 2023-02-10 |
| Publishing country | Germany |
| Document type | Randomized Controlled Trial ; Journal Article |
| ZDB-ID | 2213295-8 |
| ISSN | 1861-0692 ; 1861-0684 |
| ISSN (online) | 1861-0692 |
| ISSN | 1861-0684 |
| DOI | 10.1007/s00392-023-02164-w |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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