Table 3.
Incidence of adverse events (percent patients) reported in patients treated with dapagliflozin 5 mg, dapagliflozin 10 mg, or placebo
| Placebo | Dapagliflozin | ||
|---|---|---|---|
| (N = 1393) | 5 mg (N = 1145) | 10 mg (N = 1193) | |
| Hypoglycemiaa | 7.0 | 10.9 | 10.2 |
| Genital infectionb | 0.9 | 5.7 | 4.8 |
| Urinary tract infection | 3.7 | 5.7 | 4.3 |
| Back pain | 3.2 | 3.1 | 4.2 |
| Polyuria | 1.7 | 2.9 | 3.8 |
| Dysuria | 0.7 | 1.6 | 2.1 |
| Dyslipidemia | 1.5 | 2.1 | 2.5 |
Pooled data from 12 placebo-controlled phase II/III clinical studies. Modified with permission from Ptaszynska et al. [71]
aMajor hypoglycemia requiring assistance or treatment and which, if left untreated may be life-threatening, occurred in 0.1 % of each of the dapagliflozin groups, and in 0.1 % of placebo recipients. Most hypoglycemic events were from add-on to insulin and add-on to sulfonylureas
bVulvovaginitis/balanitis and related genital infections