Objective: Adipose tissue inflammation impairs arterial compliance at early stages of type 2 diab... more Objective: Adipose tissue inflammation impairs arterial compliance at early stages of type 2 diabetes mellitus (T2DM). We aimed to assess the impact of empagliflozin as compared to sitagliptin on aortic stiffness and serum adiponectin (ADPN), an adipocytokine with insulin-sensitizing, anti-inflammatory and anti-atherogenic properties, in normotensive patients with T2DM. Design and method: In this 24-week, randomized, open, parallel-group, controlled trial, 106 Caucasian normotensive T2DM subjects, inadequately controlled on metformin monotherapy (at least 1700 mg daily), were randomly assigned to receive 25 mg empagliflozin (n = 54) or 100 mg sitagliptin (n = 52) orally once daily. Arterial stiffness was assessed as carotid-femoral pulse wave velocity (PWV) measured via Complior (Artech Medical), whereas a sandwich enzyme-linked immunosorbent assay was employed for ADPN measurement. Office blood pressure (BP) was measured using a validated automated sphygmomanometer (Omron 705IT). Three measurements were taken at a 1-minute interval and were averaged for a single systolic/diastolic BP value. Results: In the entire study population, mean age was 50.4 years, diabetes duration 6.1 years, baseline HbA1c 7.7%, fasting plasma glucose [FPG] 159 mg/dl, body mass index 30.2 ± 4.1 kg/m2, systolic/diastolic BP 132.2/82.9 mmHg, glomerular filtration rate 89.9 mL/min/1.73m2, PWV 13.0 ± 2.1 m/s and ADPN 6.0 ± 1.8 &mgr;g/ml at baseline. After 24 weeks significant changes were observed in HbA1c and FPG with both empagliflozin (−0.72% and −25.3 mg/dl, respectively) and sitagliptin (−0.70% and −23.2 mg/dl, respectively; p < 0.001 for all comparisons, between-group differences being non-significant), whereas hypoglycemia rates were comparable (2.1% with empagliflozin and 1.9% with sitagliptin; p = 0.494). BP values decreased with empagliflozin (−4.9 ± 0.9 mmHg [p < 0.05] systolic /−2.4 ± 0.4 mmHg [p < 0.05] diastolic), but not with sitagliptin (−1.3 ± 1.0 mmHg [p = 0.672] systolic /−0.1 ± 0.5 mmHg [p = 0.848] diastolic). Body weight declined by 3.8 kg (p < 0.001) with empagliflozin and 0.5 kg (p = 0.082) with sitagliptin (p < 0.001 for between-group difference). PWV decreased (−3.1 ± 0.3 m/s [p < 0.001] with empagliflozin and −1.6 ± 0.4 m/s [p < 0.05] with sitagliptin) and ADPN increased (3.3 ± 0.8 [p < 0.001] with empagliflozin and 1.3 ± 0.3 mg/L [p < 0.05] with sitagliptin), the differences being greater with empagliflozin (p < 0.01 for both comparisons). Conclusions: Addition of empagliflozin to metformin may attenuate adipose tissue inflammation and arterial stiffness to a greater extent than sitagliptin in normotensive patients with T2DM.
Objective: Adipose tissue inflammation impairs arterial compliance at early stages of type 2 diab... more Objective: Adipose tissue inflammation impairs arterial compliance at early stages of type 2 diabetes mellitus (T2DM). We aimed to assess the impact of empagliflozin as compared to sitagliptin on aortic stiffness and serum adiponectin (ADPN), an adipocytokine with insulin-sensitizing, anti-inflammatory and anti-atherogenic properties, in normotensive patients with T2DM. Design and method: In this 24-week, randomized, open, parallel-group, controlled trial, 106 Caucasian normotensive T2DM subjects, inadequately controlled on metformin monotherapy (at least 1700 mg daily), were randomly assigned to receive 25 mg empagliflozin (n = 54) or 100 mg sitagliptin (n = 52) orally once daily. Arterial stiffness was assessed as carotid-femoral pulse wave velocity (PWV) measured via Complior (Artech Medical), whereas a sandwich enzyme-linked immunosorbent assay was employed for ADPN measurement. Office blood pressure (BP) was measured using a validated automated sphygmomanometer (Omron 705IT). Three measurements were taken at a 1-minute interval and were averaged for a single systolic/diastolic BP value. Results: In the entire study population, mean age was 50.4 years, diabetes duration 6.1 years, baseline HbA1c 7.7%, fasting plasma glucose [FPG] 159 mg/dl, body mass index 30.2 ± 4.1 kg/m2, systolic/diastolic BP 132.2/82.9 mmHg, glomerular filtration rate 89.9 mL/min/1.73m2, PWV 13.0 ± 2.1 m/s and ADPN 6.0 ± 1.8 &mgr;g/ml at baseline. After 24 weeks significant changes were observed in HbA1c and FPG with both empagliflozin (−0.72% and −25.3 mg/dl, respectively) and sitagliptin (−0.70% and −23.2 mg/dl, respectively; p < 0.001 for all comparisons, between-group differences being non-significant), whereas hypoglycemia rates were comparable (2.1% with empagliflozin and 1.9% with sitagliptin; p = 0.494). BP values decreased with empagliflozin (−4.9 ± 0.9 mmHg [p < 0.05] systolic /−2.4 ± 0.4 mmHg [p < 0.05] diastolic), but not with sitagliptin (−1.3 ± 1.0 mmHg [p = 0.672] systolic /−0.1 ± 0.5 mmHg [p = 0.848] diastolic). Body weight declined by 3.8 kg (p < 0.001) with empagliflozin and 0.5 kg (p = 0.082) with sitagliptin (p < 0.001 for between-group difference). PWV decreased (−3.1 ± 0.3 m/s [p < 0.001] with empagliflozin and −1.6 ± 0.4 m/s [p < 0.05] with sitagliptin) and ADPN increased (3.3 ± 0.8 [p < 0.001] with empagliflozin and 1.3 ± 0.3 mg/L [p < 0.05] with sitagliptin), the differences being greater with empagliflozin (p < 0.01 for both comparisons). Conclusions: Addition of empagliflozin to metformin may attenuate adipose tissue inflammation and arterial stiffness to a greater extent than sitagliptin in normotensive patients with T2DM.
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