Efficacy and safety of dapagliflozin in Asian patients: A pooled analysis.

Background: The efficacy and safety of dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has been demonstrated predominantly in Western populations. This study examined the efficacy and safety of dapagliflozin in Asian patients with type 2 diabetes mellitus (T2DM) from eight Phase IIb/III double-blind trials of up to 24 weeks, treated with placebo (n = 497) or dapagliflozin 5 mg (n = 491) or 10 mg (n = 465).

Methods: Efficacy was assessed in the pooled population receiving dapagliflozin 5, 10 mg or placebo over 24 weeks. Safety and tolerability were assessed by collating data for overall adverse events (AEs) and AEs of special interest over the 24-week period.

Results: Demographic and baseline characteristics were comparable across treatment groups. Placebo-corrected adjusted mean changes from baseline at 24 weeks in the dapagliflozin 5 and 10 mg groups, respectively, were -0.52% and -0.58% for HbA1c and -1.34 and -1.80 kg for body weight. Modest reductions in blood pressure were also noted with dapagliflozin. Overall, 56.5%, 53.6%, and 58.7% of patients in the placebo and dapagliflozin 5 and 10 mg groups, respectively, experienced AEs, compared with 2.8%, 4.1%, and 2.4% experiencing serious AEs. Genital infections were more frequent with dapagliflozin 10 mg than placebo, whereas the pattern for urinary tract infections was less clear. A transient reduction in mean estimated glomerular filtration rate was noted with dapagliflozin, but was not associated with an increased frequency of serious renal AEs. In contrast, placebo-corrected reductions in urinary albumin : creatinine ratio in patients with albuminuria at baseline suggest a potential renoprotective effect of dapagliflozin.

Conclusion: Dapagliflozin was efficacious and well tolerated in Asian patients with T2DM.