Table 4.
Mean (SD) change from baselinea in laboratory parameters of interest in asenapine-treated pediatric patients with bipolar I disorder
| Placebo/asenapine N = 80 |
Asenapine/asenapine N = 241 |
Total N = 321 |
|
|---|---|---|---|
| Fasting cholesterol, mg/dL | 2.67 (22.93) | −3.40 (22.31) | −1.89 (22.54) |
| Fasting triglycerides, mg/dL | 0.62 (50.97) | −0.97 (58.76) | −0.53 (56.81) |
| Fasting glucose, mg/dL | 0.90 (13.33) | 1.26 (13.69) | 1.26 (13.51) |
| HbA1c (≥7 %), n | 0 | 0 | 0 |
| Fasting insulin, µU/mL | 4.51 (19.72) | −6.35 (55.72) | −3.58 (49.27) |
| Prolactin, ng/mL | 2.31 (12.30) | −0.39 (14.07) | 0.27 (13.69) |
HbA 1c glycosylated hemoglobin, SD standard deviation
aMean changes and shifts were calculated using the open-label extension baseline