Composite responder rates at 15 and 27 weeks.
| Composite Responder Analyses | Placebo, n = 223 | 15 Weeks Milnacipran 100 mg/day, n = 224 | Milnacipran 200 mg/day, n = 441 | Placebo, n = 223 | 27 Weeks Milnacipran 100 mg/day, n = 224 | Milnacipran 200 mg/day, n = 441 |
|---|---|---|---|---|---|---|
| Fibromyalgiaa | ||||||
| BOCF/LOCFc, % | 12.1 | 19.6 (0.028) | 19.3 (0.017) | 13.0 | 18.3 (0.245) | 18.1 (0.105) |
| Observed cases, % | 17.3 | 32.8 (0.003) | 32.8 (< 0.001) | 19.4 | 33.3 (0.056) | 31.9 (0.017) |
| Fibromyalgia painb | ||||||
| BOCF/LOCFc, % | 19.3 | 27.2 (0.056) | 26.8 (0.032) | 18.4 | 25.9 (0.072) | 25.6 (0.034) |
| Observed cases, % | 27.2 | 45.2 (0.003) | 45.4 (< 0.001) | 27.9 | 43.8 (0.021) | 45.2 (0.001) |
Values in parentheses represent p values vs placebo. Composite responder rates determined as follows:
↵a FM patients reporting ≥ 30% improvement from baseline in patient experience diary (PED) 24-h morning recall pain; Patient Global Impression of Change (PGIC) = 1 or 2; and ≥ 6-point improvement from baseline in SF-36 Physical Component Summary (PCS);
↵b Fibromyalgia pain: patients reporting ≥ 30% improvement from baseline in PED 24-h morning recall pain and PGIC = 1 or 2.
↵c Statistical methodology was baseline observation carried forward (BOCF) for patients discontinuing before Week 15 and last observation carried forward (LOCF) for patients completing Week 15 landmark but discontinuing before Week 27.