Frequency of Adverse Events in Placebo-Controlled Studies of Pramlintide in Type 1 Diabetes
| Trial | Any Nausea % | Severe Nausea % | Any Anorexiaaor Reduced Appetite % | Severe Anorexia or Reduced Appetite % | Any Vomiting % | Severe Vomiting % |
|---|---|---|---|---|---|---|
| aAnorexia was defined as decreased appetite, early satiety or gastric fullness, loss of appetite, or no appetite. | ||||||
| bThe rate of 95.1% occurred in persons in the pramlintide 30-μg group. | ||||||
| Edelman et al, 20065 | ||||||
| Pramlintide | 48.5–95.1b | 4.0–7.3 | 6.9–14.6 | 0.0 | 11.9–17.1 | 2.4–5.9 |
| Placebo | 36.1 | 0.7 | 2.0 | 0.0 | 6.1 | 0.7 |
| Whitehouse et al, 200210 | ||||||
| Pramlintide | 46.5 | 6.2 | 17.7 | 2.5 | 11.5 | 2.1 |
| Placebo | 21.9 | 1.7 | 2.1 | 0.0 | 8.0 | 0.4 |
| Ratner et al, 20047 | ||||||
| Pramlintide | 47.9–59.0 | 5.8–8.5 | 11.0–18.0 | 0.6–1.9 | 9.8–12.0 | 0.6–1.8 |
| Placebo | 12.0 | 1.3 | 2.6 | 0.0 | 6.5 | 0.6 |