Why carry out this study?

Empagliflozin is a potent sodium-glucose co-transporter-2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes mellitus (T2DM), including reduction of cardiovascular (CV) mortality in patients with T2DM and CV disease.

The clinical efficacy and safety profile of empagliflozin in T2DM has been well documented; however, new safety signals of increased lower limb amputations and fractures reported for another SGLT2 inhibitor have prompted a review of the risks associated with this drug class.

This study examined the safety and tolerability of empagliflozin in patients with T2DM using data pooled from 20 placebo-controlled clinical trials based on over 16,480 patient-years’ exposure to empagliflozin.

What was learned from the study?

This updated pooled analysis confirmed that both empagliflozin 10 mg and 25 mg are well tolerated in patients with T2DM.

These results reinforce the findings of a favorable benefit–risk profile for empagliflozin from previous clinical trials in patients with T2DM, including trials establishing the effects of empagliflozin on CV and all-cause mortality.