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Table 3 Incidence of adverse events (percent patients) reported in patients treated with dapagliflozin 5 mg, dapagliflozin 10 mg, or placebo

From: Efficacy and safety of dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in diabetes mellitus

 

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

  1. Pooled data from 12 placebo-controlled phase II/III clinical studies. Modified with permission from Ptaszynska et al. [71]
  2. 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
  3. bVulvovaginitis/balanitis and related genital infections