Table 2.
Rates and odds ratio of angioedema (confirmed cases)
| Treatment group | Events (n) | Exposed (n) | Rate (%) | Odds ratio (95% CI) Versus comparators | P value |
|---|---|---|---|---|---|
| All | |||||
| Comparator | 8 | 5368 | 0.15 | ||
| Vildagliptin 50mg qd | 1 | 1239 | 0.08 | 0.54 (0.07-4.33) | NS |
| Vildagliptin 50mg bid | 12 | 4764 | 0.25 | 1.69 (0.69-4.14) | NS |
| Vildagliptin 100mg qd | 6 | 2550 | 0.24 | 1.58 (0.55-4.56) | NS |
| All Vildagliptin | 19 | 8553 | 0.22 | 1.49 (0.65-3.41) | NS |
| ACE inhibitor-treated | |||||
| Comparator | 1 | 1819 | 0.05 | ||
| Vildagliptin 50mg qd | 1 | 351 | 0.28 | 5.19 (0.32-83.24) | NS |
| Vildagliptin 50mg bid | 8 | 1540 | 0.52 | 9.49 (1.19-75.93) | P<O.05 |
| Vildagliptin 100mg qd | 5 | 863 | 0.58 | 10.59 (1.24-90.81) | P<O.05 |
| All Vildagliptin | 14 | 2754 | 0.51 | 9.29 (1.22-70.70) | P<O.05 |
| Non ACE inhibitor-treated | |||||
| Comparator | 7 | 3549 | 0.20 | ||
| Vildagliptin 50mg qd | 0 | 888 | 0 | 0 | NS |
| Vildagliptin 50mg bid | 4 | 3224 | 0.12 | 0.63 (0.18-2.15) | NS |
| Vildagliptin 100mg qd | 1 | 1687 | 0.06 | 0.30 (0.04-2.44) | NS |
| All Vildagliptin | 5 | 5799 | 0.09 | 0.44 (0.14-1.38) | NS |
| ARB-treated | |||||
| Comparator | 2 | 886 | 0.23 | ||
| Vildagliptin 50mg qd | 0 | 162 | 0 | 0.00 (n.a.) | NS |
| Vildagliptin 50mg bid | 3 | 701 | 0.43 | 1.90 (0.32-11.40) | NS |
| Vildagliptin 100mg qd | 0 | 473 | 0 | 0 (n.a.) | NS |
| All Vildagliptin | 3 | 1336 | 0.22 | 0.99 (0.17-5.97) | NS |
| Non ARB-treated | |||||
| Comparator | 6 | 4482 | 0.13 | ||
| Vildagliptin 50mg qd | 1 | 1077 | 0.09 | 0.69 (0.08-5.76) | NS |
| Vildagliptin 50mg bid | 9 | 4063 | 0.22 | 1.66 (0.59-4.66) | NS |
| Vildagliptin 100mg qd | 6 | 2077 | 0.29 | 2.16 (0.70-6.71) | NS |
| All Vildagliptin | 16 | 7217 | 0.22 | 1.66 (0.65-4.24) | NS |
*Comparators included placebo, metformin, pioglitazone, rosiglitazone, glimepiride, and acarbose. ACE indicates angiotensin-converting enzyme, ARB indicates angiotensin receptor blocker