Safety and tolerability of empagliflozin in patients with type 2 diabetes
S Kohler, A Salsali, S Hantel, G Kim, HJ Woerle, UC Broedl · Diabetologie und Stoffwechsel · 2016 · Heft 04
Bibliografische Angaben
Zusammenfassung
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 group…