Empagliflozin had a neutral impact on left ventricular global longitudinal strain (MD 0.53%) and peak oxygen uptake compared to sitagliptin in patients with type 2 diabetes and normal heart function.
RCT (n=44)
Open-label
Randomized
No
Does empagliflozin improve myocardial contractility and cardiopulmonary fitness in subjects with type 2 diabetes without heart disease?
Empagliflozin has a neutral impact on LV-GLS and exercise tolerance in T2D patients with normal LV function, though it may improve contractility in those with subclinical dysfunction.
Mean Difference: 0.53 (95% CI -0.56–1.62)
Abstract Background The mechanism through which sodium-glucose cotransporter 2 inhibitors (SGLT2i) prevent the incidence of heart failure and/or affect cardiac structure and function remains unclear. Methods The EMPA-HEART trial is aimed at verifying whether empagliflozin improves myocardial contractility (left ventricle global longitudinal strain, LV-GLS) and/or cardiopulmonary fitness (peak oxygen uptake, VO2peak) in subjects with type 2 diabetes (T2D) without heart disease. Patients with T2D, normal LV systolic function (2D-Echo EF > 50%), and no heart disease were randomized to either empagliflozin 10 mg or sitagliptin 100 mg for 6 months and underwent repeated cardiopulmonary exercise tests with echocardiography and determination of plasma biomarkers. Results Forty-four patients completed the study, 22 per arm. Despite comparable glycaemic control, modest reductions in body weight (− 1.6; − 2.7/− 0.5 kg, p = 0.03) and plasma uric acid (− 1.5; − 2.3/− 0.6, p = 0.002), as well as an increase in haemoglobin (+ 0.7; + 0.2/+ 1.1 g/dL, p = 0.0003) were evident with empagliflozin. No difference was detectable in either LV-GLS at 1 month (empagliflozin vs sitagliptin: + 0.44; − 0.10/+ 0.98%, p = 0.11) and 6 months of therapy (+ 0.53; − 0.56/+ 1.62%), or in VO 2peak (+ 0.43; − 1.4/+ 2.3 mL/min/kg, p = 0.65). With empagliflozin, the subgroup with baseline LV-GLS below the median experienced a greater increase (time*drug p < 0.05) in LV-GLS at 1 month (+ 1.22; + 0.31/+ 2.13%) and 6 months (+ 2.05; + 1.14/+ 2.96%), while sitagliptin induced a modest improvement in LV-GLS only at 6 months (+ 0.92; + 0.21/+ 0.62%). Conclusions Empagliflozin has neutral impact on both LV-GLS and exercise tolerance in subjects with T2D and normal left ventricular function. However, in patients with subclinical dysfunction (LV-GLS < 16.5%) it produces a rapid and sustained amelioration of LV contractility. Trial registration EUDRACT Code 2016-002225-10
Nesti et al. (Mon,) conducted a rct in Type 2 diabetes without heart disease (n=44). Empagliflozin vs. Sitagliptin 100 mg was evaluated on Left ventricle global longitudinal strain (LV-GLS) at 6 months (MD 0.53%, 95% CI -0.56 to 1.62). Empagliflozin had a neutral impact on left ventricular global longitudinal strain (MD 0.53%) and peak oxygen uptake compared to sitagliptin in patients with type 2 diabetes and normal heart function.