Table 3 Safety endpoints
Adverse events | Placebo | Alogliptin | p value | Inter. p |
|---|---|---|---|---|
eGFR ≥ 60 stratum | ||||
Any serious adverse event | 607 (30.9%) | 564 (28.4%) | 0.088 | 0.42 |
Serious hypoglycemia | 4 (0.2%) | 9 (0.5%) | 0.17 | 0.14 |
Any adverse event | 1490 (75.9%) | 1532 (77.3%) | 0.32 | 0.95 |
Any hypoglycemia | 91 (4.6%) | 120 (6.1%) | 0.048 | 0.007 |
Pancreatitis | 0.36 | |||
Acute | 5 (0.3%) | 5 (0.3%) | 0.99 | |
Chronic | 4 (0.2%) | 2 (0.1%) | 0.41 | |
Angioedema | 6 (0.3%) | 7 (0.4%) | 0.80 | 0.78 |
Malignancy | 30 (1.5%) | 38 (1.9%) | 0.35 | 0.28 |
Dialysis | 3 (0.2%) | 1 (0.1%) | 0.31 | 0.27 |
Serum aminotransferases > 3× upper limit of normal at any time during trial | 0.11 | |||
Alanine aminotransferase | 37 (1.9%) | 43 (2.2%) | 0.53 | |
Aspartate aminotransferase | 32 (1.6%) | 27 (1.4%) | 0.49 | |
eGFR < 60 stratum | ||||
Any serious adverse event | 345 (48.2%) | 343 (47.8%) | 0.88 | 0.42 |
Serious hypoglycemia | 12 (1.7%) | 9 (1.3%) | 0.51 | 0.14 |
Any adverse event | 621 (86.7%) | 628 (87.5%) | 0.68 | 0.95 |
Any hypoglycemia | 82 (11.5%) | 61 (8.5%) | 0.062 | 0.007 |
Pancreatitis | 0.36 | |||
Acute | 3 (0.4%) | 7 (1.0%) | 0.21 | |
Chronic | 0 | 3 (0.4%) | 0.083 | |
Angioedema | 7 (1.0%) | 10 (1.4%) | 0.45 | 0.78 |
Malignancy | 21 (2.9%) | 17 (2.4%) | 0.51 | 0.28 |
Dialysis | 19 (2.7%) | 23 (3.2%) | 0.54 | 0.27 |
Serum aminotransferases > 3× upper limit of normal at any time during trial | 0.11 | |||
Alanine aminotransferase | 9 (1.3%) | 21 (2.9%) | 0.027 | |
Aspartate aminotransferase | 11 (1.5%) | 21 (2.9%) | 0.075 | |