Abstract
Background: Diabetes increases the risk for cardiovascular (CV) events. It has recently been shown that the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors leads to a reduction in CV outcomes in patients with type 2 diabetes mellitus (T2DM), including mortality and heart failure hospitalization. The exact mechanisms of how SGLT2 inhibitors lead to this CV risk reduction remain incompletely understood. The study of DAPAgliflozin on CARDiac substrate uptake, myocardial efficiency and myocardial contractile work in type 2 diabetes patients (DAPACARD) (NCT03387683) explores the possible effects of dapagliflozin, an SGLT2 inhibitor, on cardiac work, metabolism, and biomarker levels.Methods: DAPACARD is an international, randomized, double-blind trial that aims to examine the effects of dapagliflozin versus matching placebo in 52 patients with T2DM that are on stable metformin therapy prior to and during the 6 weeks of treatment. The primary efficacy endpoint is change in global longitudinal strain of the left ventricle (GLSLV) measured with magnetic resonance imaging (MRI) between baseline (pre-treatment) and end of study (on-treatment). The secondary endpoint is the corresponding change in myocardial efficiency measured as external left ventricular work divided by total left ventricular work, which is estimated using [11C]-acetate clearance using positron emission tomography (PET).Conclusion: The DAPACARD study is an extensive investigation of cardiac function and metabolism, by advanced imaging with PET and MRI, as well as biomarkers, performed in order to further explore how the SGLT2 inhibitor dapagliflozin could influence cardiovascular outcomes in patients with T2DM.
Highlights
Diabetes increases the risk for cardiovascular (CV) events
For both of the sodium-glucose cotransporter 2 (SGLT2) inhibitors, the positive cardiovascular effects became apparent within months from treatment start, suggesting that mechanisms beyond improved glucose control and reduced atherosclerosis are involved in the CV risk reduction (5)
The effect of dapagliflozin on CV outcomes in a broad type 2 diabetes mellitus (T2DM) population is currently investigated in a large phase III study (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events—DECLARE-TIMI 58 [NCT01730534]), with results expected in the second half of 2018 (7)
Summary
It has recently been shown that the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors leads to a reduction in CV outcomes in patients with type 2 diabetes mellitus (T2DM), including mortality and heart failure hospitalization. The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin showed a reduction in CV outcomes, including CV mortality and heart failure admissions, in patients with T2DM (4). Another SGLT2 inhibitor, canagliflozin, recently showed similar results including a decrease in heart failure admissions, but not in all-cause mortality, in patients with T2DM (5,6) For both of the SGLT2 inhibitors, the positive cardiovascular effects became apparent within months from treatment start, suggesting that mechanisms beyond improved glucose control and reduced atherosclerosis are involved in the CV risk reduction (5). The effect of dapagliflozin on CV outcomes in a broad T2DM population is currently investigated in a large phase III study (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events—DECLARE-TIMI 58 [NCT01730534]), with results expected in the second half of 2018 (7)
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