Safety and tolerability of empagliflozin in patients with type 2 diabetes

Aim: To assess the safety and tolerability of empagliflozin using data pooled from Phase I, II and III trials in patients with type 2 diabetes (T2DM).

Methods: Pooled safety data were analyzed from patients with T2DM who received placebo (n = 3695), empagliflozin 10 mg (n = 3806) or empagliflozin 25 mg (n = 4782) in Phase I, II and III trials (including extensions). Adverse events (AEs) were assessed descriptively in patients who took ≥1 dose of study drug. Incidences are rates per 100 patient-years.

Results: Total exposure was 3254, 3840 and 5649 patient-years in the placebo, empagliflozin 10 mg and 25 mg groups, respectively. There were similar incidences of the following events across the treatment groups: any AEs (215.1, 176.3 and 167.1 in the placebo, empagliflozin 10 mg and 25 mg groups, respectively), serious AEs (16.4, 10.7 and 10.8, respectively), severe AEs (10.4, 6.9 and 6.8, respectively), confirmed hypoglycaemic AEs (plasma glucose ≤70 mg/dl and/or requiring assistance: 19.7, 16.4 and 12.1, respectively) and events consistent with urinary tract infections (based on 77 preferred terms [PTs]: 11.3, 10.4 and 9.4, respectively). The incidence of events consistent with genital infections (based on 89 PTs) was higher with empagliflozin 10 mg or 25 mg than placebo (4.7, 5.0 and 1.3, respectively). The incidence of AEs consistent with volume depletion (based on 8 PTs) was 1.6, 1.5 and 1.3 for placebo, empagliflozin 10 mg and 25 mg, respectively.

Conclusion: Empagliflozin 10 mg and 25 mg were well tolerated in a pooled analysis of data from > 12000 patients with T2DM.