Table 2.
Overall safety profile across studies
| Patients n (%) or % | Linagliptin [19, 20] | Saxagliptin [18] | Sitagliptin [16] | Vildagliptin [15] | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall RI | Severe RI | Overall RI | Overall RI | Moderate RI | Severe RI | |||||||
| Active (n = 113) | PBO (n = 122) | Active (n = 68) | PBO (n = 65) | Active (n = 85) | PBO (n = 85) | Active (n = 65) | PBO/glipizidea (n = 26) | Active (n = 122) | PBO (n = 89) | Active (n = 94) | PBO (n = 64) | |
| Any AE | 76.1% | 73.8% | 64 (94.1) | 60 (92.3) | 64 (75.3) | 60 (70.6) | 52 (80.0) | 22 (84.6) | 103 (84.4) | 76 (85.4) | 80 (85.1) | 56 (87.5) |
| Drug-related AEb | 23.9% | 24.6% | 31 (45.6) | 29 (44.6) | – | – | 8 (12.3) | 5 (19.2) | 31 (25.4) | 22 (24.7) | 24 (25.5) | 18 (28.1) |
| Any SAE | 7.1% | 8.2% | 25 (36.8) | 27 (41.5) | 23 (27.1) | 24 (28.2) | 20 (30.8) | 10 (38.5) | 26 (21.3) | 17 (19.1) | 23 (24.5) | 16 (25.0) |
| Any AE leading to discontinuation | 3.5% | 4.9% | 9 (13.2) | 11 (16.9) | 10 (11.8) | 7 (8.2) | 10 (15.4) | 4 (15.4) | 6 (4.9) | 5 (5.6) | 9 (9.6) | 4 (6.3) |
| Deaths | – | – | 3 (4.4) | 3 (4.6) | 3 (3.5) | 4 (4.7) | 5 (7.7) | 1 (3.8) | 1 (0.8) | 0 (0.0) | 3 (3.2) | 1 (1.6) |
Long-term study data presented, except for linagliptin study where overall RI group data of 12-week placebo-controlled phase was presented
AE adverse event, PBO placebo, RI renal impairment, SAE serious adverse event
a12-week placebo-controlled phase data was not available separately, hence data presented in the column are of 54-week (combined PBO/active phases) and should not to be compared with the placebo arms in other trials
bEvents suspected to be drug related