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Effect of empagliflozin on coronary microvascular function in patients with type 2 diabetes mellitus-A randomized,
Hannah Elena Suhrs1, Malin Nilsson2, Kira Bang Bové1
1Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Purpose:
Results from large scale cardiovascular outcome trials in patients with type 2 diabetes mellitus (DM2) have found that sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce cardiovascular death and hospitalization for heart failure, but the mechanisms behind the beneficial cardiovascular effects are not fully understood. We tested the hypothesis that the SGLT2i, empagliflozin, improves non-endothelial dependent coronary microvascular function, thereby leading to better cardiac function.
Methods:
Patients with DM2 followed at the endocrinology outpatient clinic at Bispebjerg University Hospital were included in a double blinded, placebo-controlled cross-over study. Participants were allocated equally to each treatment sequence using simple randomization and treated with empagliflozin 25 mg and placebo for 12 weeks, interrupted by 2 weeks wash-out period. The primary outcome was coronary microvascular function, assessed as coronary flow velocity reserve (CFVR) and measured with transthoracic doppler echocardiography. Echocardiographic parameters of cardiac function were measured, and blood samples were analyzed for a broad panel of cardiovascular biomarkers.
Results:
Thirteen patients were randomized to each sequence and 10 and 9 completed the study according to protocol, respectively, and were included in the analysis of outcome parameters. We found no improvement in CFVR (change in the empagliflozin period was -0.16 (SD 0.58)). There were no effects on cardiac systolic function or indicators of cardiac filling pressure. Well-known effects of empagliflozin were obtained, such as weight loss and reduction in Hba1c level. Creatinine level increased but remained within normal range. We observed a clear trend of reduction in cardiovascular biomarkers after empagliflozin treatment and increased levels after the placebo period. No serious adverse reactions were reported.
Conclusions:
Despite effect on weight-loss, Hba1c and biomarkers, treatment with empagliflozin for 12 weeks did not improve CFVR in patients with DM2.
Insights
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) like empagliflozin did not improve coronary microvascular function in type 2 diabetes patients. While empagliflozin showed benefits in weight loss and biomarkers, it did not enhance cardiac function in this study.
Area of Science:
- Cardiology
- Endocrinology
- Pharmacology
Background:
- Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are known to reduce cardiovascular events in type 2 diabetes mellitus (DM2).
- The precise mechanisms underlying the cardiovascular benefits of SGLT2i, such as empagliflozin, remain incompletely understood.
- Investigating the impact on coronary microvascular function is crucial for understanding SGLT2i's cardioprotective effects.
Purpose of the Study:
- To test the hypothesis that empagliflozin improves non-endothelial dependent coronary microvascular function in patients with DM2.
- To assess the effect of empagliflozin on cardiac function and cardiovascular biomarkers.
- To determine if empagliflozin influences coronary flow velocity reserve (CFVR) in DM2 patients.
Main Methods:
- A double-blinded, placebo-controlled, cross-over study involving patients with DM2.
- Participants received empagliflozin (25 mg) or placebo for 12 weeks, with a 2-week wash-out period.
- Coronary microvascular function was assessed using coronary flow velocity reserve (CFVR) via transthoracic Doppler echocardiography; cardiac function and biomarkers were also measured.
Main Results:
- Empagliflozin treatment did not significantly improve CFVR in patients with DM2 (change of -0.16).
- No improvements were observed in cardiac systolic function or indicators of cardiac filling pressure.
- Empagliflozin led to expected weight loss and reduced HbA1c, with a trend towards reduced cardiovascular biomarkers, though creatinine levels slightly increased within the normal range.
Conclusions:
- Twelve weeks of empagliflozin treatment did not enhance coronary microvascular function (CFVR) in patients with type 2 diabetes.
- Despite positive effects on weight, HbA1c, and certain biomarkers, empagliflozin did not improve microvascular function in this cohort.
- Further research is needed to fully elucidate the mechanisms of SGLT2i's cardiovascular benefits.
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