Table 2.
Skin Nodules and Injection Site-Related Adverse Events Associated with Exenatide Once-Weekly Injections
| EQW | Placebo* | |
|---|---|---|
| Skin nodules (placebo-controlled)† | ||
| Subjects (n) | 15 | 13 |
| Subjects with ≥1 palpable nodules [n (%)] | 12 (80) | 7 (53.8) |
| Injections associated with nodule (%) | 83.0 | 42.9 |
| Subjects with ≥1 nodule- associated AE [n (%)]‡ | 1 (6.7) | 2 (15.4) |
| Mean time to first detection (days) | 28 | 28 |
| Mean duration of nodules (days) | 31.7 | 20.7 |
| Injection site-related adverse events over 30 weeks (DURATION-1)† | ||
| Total injections (n) | 4,161 | — |
| Pruritus or urticaria [n (% injections)] | 200 (4.8) | — |
| Pruritus [n (% patients)] | 26 (17.6) | |
| Irritation, burning, or pain [n (%)] | 58 (1.4) | — |
| Erythema [n (%)] | 37 (0.9) | — |
Data shown are from those on file at Amylin Pharmaceuticals, Inc.
*
Microspheres without exenatide.
†
The placebo-controlled study and DURATION-1 had treatment phases of 15 and 30 weeks, respectively.
‡
Nodules were not considered adverse events (AEs) unless accompanied by prolonged pain, induration, redness, bleeding, or inflammation.37
EQW, exenatide once weekly.