Table 3.
Rates and odds ratio of angioedema for both confirmed cases and cases with insufficient data to adjudicate
| Treatment group | Events (n) | Exposed (n) | Rate (%) | Odds ratio (95% CI) Versus comparators | P value |
|---|---|---|---|---|---|
| All | |||||
| Comparator | 11 | 5368 | 0.20 | ||
| Vildagliptin 50mg qd | 2 | 1239 | 0.16 | 0.79 (0.17-3.56) | NS |
| Vildagliptin 50mg bid | 16 | 4764 | 0.34 | 1.64 (0.76-3.54) | NS |
| Vildagliptin 100mg qd | 7 | 2550 | 0.27 | 1.34 (0.52-3.46) | NS |
| All Vildagliptin | 25 | 8553 | 0.29 | 1.43 (0.70-2.90) | 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 | 10 | 1540 | 0.65 | 11.88 (1.52-92.93) | P<O.05 |
| Vildagliptin 100mg qd | 5 | 863 | 0.58 | 10.59 (1.24-90.81) | P<O.05 |
| All Vildagliptin | 16 | 2754 | 0.58 | 10.62 (1.41-80.18) | P<O.05 |
| Non ACE inhibitor-trated | |||||
| Comparator | 10 | 3549 | 0.28 | ||
| Vildagliptin 50mg qd | 1 | 888 | 0.11 | 0.40 (0.05-3.12) | NS |
| Vildagliptin 50mg bid | 6 | 3224 | 0.19 | 0.66 (0.24-1.82) | NS |
| Vildagliptin 100mg qd | 2 | 1687 | 0.12 | 0.42 (0.09-1.92) | NS |
| All Vildagliptin | 9 | 5799 | 0.16 | 0.55 (0.22-1.36) | NS |
| ARB-treated | |||||
| Comparator | 3 | 886 | 0.34 | ||
| Vildagliptin 50mg qd | 1 | 162 | 0.62 | 1.83 (0.19-17.68) | NS |
| Vildagliptin 50mg bid | 3 | 701 | 0.43 | 1.27 (0.25-6.29) | NS |
| Vildagliptin 100mg qd | 0 | 473 | 0 | 0 (n.a.) | NS |
| All Vildagliptin | 4 | 1336 | 0.30 | 0.88 (0.20-3.96) | NS |
| Non ARB-treated | |||||
| Comparator | 8 | 4482 | 0.18 | ||
| Vildagliptin 50mg qd | 1 | 1077 | 0.09 | 0.52 (0.06-4.16) | NS |
| Vildagliptin 50mg bid | 13 | 4063 | 0.32 | 1.80 (0.74-4.34) | NS |
| Vildagliptin 100mg qd | 7 | 2077 | 0.34 | 1.89 (0.68-5.22) | NS |
| All Vildagliptin | 21 | 7217 | 0.29 | 1.63 (0.72-3.69) | NS |
*All comparators included placebo, metformin, pioglitazone, rosiglitazone, glimepiride, and acarbose. ACE indicates angiotensin-converting enzyme, ARB indicates angiotensin receptor blocker