Effect of add-on empagliflozin on arterial stiffness in patients with type 2 diabetes and cardiovascular disease: an analysis from a placebo-controlled EMBLEM trial

抄録

Background: Although sodium glucose co-transporter 2 (SGLT2) inhibition has been proven to have preventive and therapeutic effects on heart failure, its clinical effect on arterial stiffness remains controversial. Herein, we sought to assess the effect of add-on empagliflozin treatment on arterial stiffness, assessed as brachial-ankle pulse wave velocity (baPWV), in patients with type 2 diabetes (T2D) and cardiovascular disease (CVD).

Methods and Results: This was a prespecified secondary analysis of the effect of empagliflozin on endothelial function in cardiovascular high risk diabetes mellitus: multi-center placebo-controlled double-blind randomized (EMBLEM) trial (UMIN000024502), which was designed primarily to evaluate the effect of empagliflozin, relative to placebo, on endothelial function in patients with T2D and CVD. The present analysis compared the changes in baPWV from baseline to week 24 between empagliflozin (10 mg once daily, n = 13) and placebo (n = 13) groups. Absolute change from baseline to week 24 in baPWV was 54.9 ± 123.9 cm/s in the empagliflozin group and 43.7 ± 166.4 cm/s in the placebo group (mean group difference, 11.2 cm/s [95% confidence interval, -108.1 to 130.5], P = 0.848).

Conclusions: Add-on empagliflozin treatment did not affect baPWV in EMBLEM trial participants.

Trial registration: University Medical Information Network Clinical Trial Registry, number 000024502