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. [ABSTRACT FROM AUTHOR]