Table 2.
Demographics and treatment dosages
| Randomized withdrawal study | Extension study | ||
|---|---|---|---|
| Nonrandomized | Randomized | All patients | |
| n = 96 | n = 20 | n = 57 | |
| Age, years, mean (SD) | 15.7 (1.3) | 15.0 (1.6) | 15.4 (1.4) |
| Female, n (%) | 86 (89.6) | 12 (60.0) | 50 (87.7) |
| White, n (%) | 86 (89.6) | 14 (70.0) | 51 (89.5) |
| BMI, kg/m2, mean (SD) | 25.8 (6.2) | 24.8 (5.3) | 26.1 (6.3) |
| Maximum tolerated dosea | |||
| 50 mg/day | 6 (6.3) | 1 (7.1)a | 3 (5.3) |
| 75 mg/day | 9 (9.4) | 4 (28.6)a | 8 (14.0) |
| 100 mg/day | 69 (71.9) | 9 (64.3)a | 46 (80.7) |
| No available MTD data | 12 (12.5) | 0a | 0 |
aAs reported in the milnacipran group only (n = 14)
BMI = body mass index, MTD = maximum tolerated dose, SD = standard deviation
MTD = maximum tolerated dose