Table 1.
Characteristics of patients with confirmed angioedema
| Characteristic | Comparators* | Vildagliptin |
|---|---|---|
| Number of patients | 8 | 19 |
| Age (years)† | 58.6 (15.1) | 58.0 (11.2) |
| Race | ||
| Black: White: Asian: Hispanic (N) | 0:5:3:0 | 3:10:4:2 |
| Gender | ||
| Female: Male (N) | 5:3 | 10:9 |
| Study drug exposure prior to angioedema (days)† | 243 (262) | 167 (173) |
| Concurrent drug use | ||
| ACE inhibitor (Yes: No) | 1:7 | 14:5 |
| ACE inhibitor exposure prior to angioedema (days)† | 706 (918) | 911 (964) |
| ARB (Yes: No) | 1:7 | 3:16 |
| ARB exposure prior to angioedema (days) | 2758 | 681 (163) |
| Localization of angioedema | ||
| Face/cheek [N (%)] | 1 (13) | 10 (53) |
| Periorbital or palpebral [N (%)] | 5 (63) | 8 (42) |
| Throat/pharynx [N (%)] | 1 (13) | 7 (37) |
| Lip[N(%)] | 1 (13) | 6 (32) |
| Tongue [N (%)] | 1 (13) | 1 (5) |
| Hands [N (%)] | 2 (25) | 1 (5) |
| Abdomen [N (%)] | 0 (0) | 0 (0) |
| Severity of angioedema | ||
| Mild (N) | 4 (50) | 10 (53) |
| Moderate (N) | 3 (37) | 4 (21) |
| Severe (N) | 1 (13) | 5 (26) |
| Treatment | ||
| Discontinuation study drug (Yes: Interrupt: No) | 2:1:5 | 3:3:13 |
| Discontinuation ACE inhibitor (Yes: No) | 1:0 | 6:7‡ |
| Discontinuation ARB (Yes: No) | 0:1 | 1:2 |
| Corticosteroids (Yes: No) | 1:7 | 7:12 |
| Anti-histamines (Yes: No) | 4:4 | 12:7 |
| Hospitalization (Yes: No) | 1:7 | 3:16 |
| Intubation (Yes: No) | 0:8 | 0:19 |
*
Comparators included placebo, metformin, pioglitazone, rosiglitazone, glimepiride, and acarbose.
†
mean (standard deviation)
‡
Information regarding discontinuation of ACE inhibitor use was not available for one patient ACE indicates angiotensin-converting enzyme, ARB indicates angiotensin receptor blocker