Safety and tolerability of empagliflozin in patients with type 2 diabetes

Empagliflozin compared with glimepiride in metformin‐treated patients with type 2 diabetes: 208‐week data from a masked randomized controlled trial

“…Empagliflozin 25 mg for 208 weeks was well tolerated, with an adverse event profile consistent with previous trials . Events consistent with genital infection, urinary tract infection, or volume depletion occurred more frequently in patients treated with empagliflozin than glimepiride.…”

Review article: new treatments in non‐alcoholic fatty liver disease

“…Dapagliflozin, canagliflozin and empagliflozin are currently approved for use in patients with T2DM, although some safety concerns have emerged from phase III trials and post‐marketing surveillance regarding urinary tract infections (UTIs). The presence of urinary glucose is thought to increase the risk of mild genital mycotic infections and UTIs . Pooled data from randomised controlled trials showed that UTIs occurred in 3.8% of patients receiving placebo vs 5.9% and 4.4% of those receiving canagliflozin 100 mg and 300 mg once daily respectively .…”

“…In post‐marketing studies, dual‐energy X‐ray absorptiometry revealed small but statistically significant reductions in bone mineral density at the hip (placebo subtracted changes of −0.9% and −1.2% for the 100‐ and 300‐mg dose groups respectively) but no other sites . The same risks do not appear to be associated with dapagliflozin or empagliflozin use . Pooled data for canagliflozin from nine clinical trials with a mean treatment time of 85 weeks reported incidence rates for bone fractures of 1.4 and 1.5 per 100 patient‐years for those on 100 and 300 mg of canagliflozin, respectively, vs 1.1 per 100 patient‐years for those on placebo …”

Combination Glucose-Lowering Therapy Plans in T2DM: Case-Based Considerations

“…In contrast, a meta-analysis of 10 randomized canagliflozin trials reported a similar incidence of UTIs between canagliflozin and placebo (RR 1.19; 95% CI 0.82-1.73; p = 0.36) or other comparators (RR 1.18; 95% CI 0.84-1.64; p = 0.34) [66]. In a pooled analysis of data from 17 clinical trials and six extension studies with empagliflozin, the incidence of events consistent with UTI was similar for placebo and empagliflozin 10 and 25 mg (11.3, 10.4, and 9.4/100 patient-years, respectively) [67]. Of note, post-marketing reports have identified infrequent, yet serious kidney infections, including urosepsis and pyelonephritis, arising in patients with UTIs taking SGLT2 inhibitors [68].…”