Table 3 Adverse events
Placebo (n = 229) | Empagliflozin 10 mg (n = 224) | Empagliflozin 25 mg (n = 223) | Sitagliptin 100 mg (n = 223) | |
|---|---|---|---|---|
Any adverse event n (%) | 175 (76.4) | 172 (76.8) | 174 (78.0) | 161 (72.2) |
Drug-relateda adverse events n (%) | 36 (15.7) | 49 (21.9) | 52 (23.3) | 31 (13.9) |
Discontinuation due to adverse events n (%) | 15 (6.6) | 11 (4.9) | 9 (4.0) | 11 (4.9) |
Severe adverse events n (%) | 14 (6.1) | 17 (7.6) | 15 (6.7) | 17 (7.6) |
Serious adverse events n (%) | 23 (10.0) | 25 (11.2) | 16 (7.2) | 18 (8.1) |
Deaths | 1 (0.4) | 0 (0.0) | 0 (0.0) | 1 (0.4) |
Adverse events with frequency of ≥5 % in any group (by preferred term) n (%) | ||||
Hyperglycaemia | 63 (27.5) | 20 (8.9) | 11 (4.9) | 28 (12.6) |
Nasopharyngitis | 27 (11.8) | 32 (14.3) | 25 (11.2) | 27 (12.1) |
Urinary tract infection | 21 (9.2) | 20 (8.9) | 14 (6.3) | 18 (8.1) |
Upper respiratory tract infection | 12 (5.2) | 17 (7.6) | 16 (7.2) | 19 (8.5) |
Dyslipidaemia | 15 (6.6) | 16 (7.1) | 14 (6.3) | 14 (6.3) |
Back pain | 12 (5.2) | 7 (3.1) | 7 (3.1) | 19 (8.5) |
Hypertension | 13 (5.7) | 11 (4.9) | 5 (2.2) | 14 (6.3) |
Bronchitis | 10 (4.4) | 11 (4.9) | 6 (2.7) | 12 (5.4) |
Diarrhoea | 9 (3.9) | 12 (5.4) | 6 (2.7) | 8 (3.6) |
Special interest categories n (%) | ||||
Confirmed hypoglycaemiab | 2 (0.9) | 2 (0.9) | 2 (0.9) | 2 (0.9) |
Events requiring assistance | 0 (0.0) | 1 (0.4) | 0 (0.0) | 0 (0.0) |
Events consistent with urinary tract infectionc | 25 (10.9) | 21 (9.4) | 20 (9.0) | 20 (9.0) |
Male | 4 (3.2) | 4 (2.8) | 4 (2.8) | 6 (4.3) |
Female | 21 (20.0) | 17 (20.7) | 16 (20.3) | 14 (17.1) |
Events consistent with genital infectiond | 4 (1.7) | 13 (5.8) | 14 (6.3) | 2 (0.9) |
Male | 2 (1.6) | 4 (2.8) | 4 (2.8) | 1 (0.7) |
Female | 2 (1.9) | 9 (11.0) | 10 (12.7) | 1 (1.2) |
Events consistent with volume depletione | 1 (0.4) | 6 (2.7) | 2 (0.9) | 3 (1.3) |