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
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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. / 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.
In: CLIN RES CARDIOL, Vol. 112, No. 7, 07.2023, p. 911-922.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - 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
AU - Prochaska, Jürgen H
AU - Jünger, Claus
AU - Schulz, Andreas
AU - Arnold, Natalie
AU - Müller, Felix
AU - Heidorn, Marc William
AU - Baumkötter, Rieke
AU - Zahn, Daniela
AU - Koeck, Thomas
AU - Tröbs, Sven-Oliver
AU - Lackner, Karl J
AU - Daiber, Andreas
AU - Binder, Harald
AU - Shah, Sanjiv J
AU - Gori, Tommaso
AU - Münzel, Thomas
AU - Wild, Philipp S
N1 - © 2023. The Author(s).
PY - 2023/7
Y1 - 2023/7
N2 - 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.
AB - 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.
KW - Humans
KW - Female
KW - Middle Aged
KW - Aged
KW - Male
KW - Diabetes Mellitus, Type 2/complications
KW - Ventricular Function, Left
KW - Stroke Volume
KW - Treatment Outcome
KW - Sodium-Glucose Transporter 2 Inhibitors/adverse effects
KW - Double-Blind Method
KW - Heart Failure/diagnosis
U2 - 10.1007/s00392-023-02164-w
DO - 10.1007/s00392-023-02164-w
M3 - SCORING: Journal article
C2 - 36763159
VL - 112
SP - 911
EP - 922
JO - CLIN RES CARDIOL
JF - CLIN RES CARDIOL
SN - 1861-0684
IS - 7
ER -
