The Effect of Empagliflozin on Left Ventricular Mass and Myocardial Extracellular Volume in Patients with Type 2 Diabetes and Cardiovascular Disease
Abstract
Background: The sodium glucose co-transporter 2 (SGLT2) inhibitors improve cardiovascular (CV) outcomes in patients with type 2 diabetes (T2DM) and established CV disease (CVD) but the mechanism driving their cardio-benefit remains poorly understood. Specifically, whether SGLT2 inhibitors have direct cardiac effects remains unknown. Objective: To evaluate the effects of the SGLT2 inhibitor empagliflozin on left ventricular (LV) mass index (LVMi) and myocardial extracellular volume (ECV) in individuals with T2DM and CVD. Method: We randomized 97 participants with T2DM and CVD to receive empagliflozin 10 mg daily or placebo for 6 months in addition to standard of care therapy. The primary outcome was change in LVMi from baseline to 6 months determined by cardiac magnetic resonance. Other outcomes included change in indexed LV end diastolic volume (LVEDVi), end systolic volume (LVESVi) or ejection fraction (LVEF) and in circulating N-terminal pro B-type natriuretic peptide (NT-proBNP) and troponin I. For our sub-study with 74 participants we assessed ECV, indexed intracellular and extracellular compartment volume (iICV, iECV), the fibrosis biomarkers soluble suppressor of tumorgenicity (sST2) and matrix metalloproteinase-2 (MMP-2). Results: In the primary study, change in LVMi from baseline to 6-months was -2·6 (7·8) g/m2 for the empagliflozin group and -0·01 (5·7) g/m2 for placebo (adjusted difference between groups -3·4 g/m2; 95% Confidence Interval (CI), -5·9 to -0·8;…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 97 participants or records.
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