Table 2.
Mean changes from randomization to end of the 12-week withdrawal period
| Mean change (SD) | ≥50% pain reduction (protocol-defined responders)
|
≥30% to <50% pain reduction (nonresponder subgroup)
|
<30% pain reduction (nonresponder subgroup)
|
||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n=50) |
Milnacipran (n=100) |
Difference | Placebo (n=18) |
Milnacipran (n=43) |
Difference | Placebo (n=36) |
Milnacipran (n=74) |
Difference | |
| VAS pain | 17.7 (24.2) | 8.3 (18.7) | 9.4b | 8.5 (16.8) | −0.5 (18.4) | 9.0a | −1.1 (13.7) | −5.3 (18.6) | 4.2 |
| FIQR total | 12.0 (18.1) | 4.8 (12.7) | 7.2c | 3.7 (14.8) | 1.9 (14.0) | 1.8 | 6.9 (13.4) | −2.8 (12.2) | 9.7c |
| SF-36 PCS | −4.5 (6.3) | −2.1 (7.1) | −2.4b | −0.2 (10.7) | −0.7 (6.1) | 0.5 | −2.5 (6.6) | 0.5 (5.8) | −3.0 |
| BDI total | 0.4 (3.3) | 0.3 (3.0) | 0.1 | 0.8 (3.3) | −0.2 (2.6) | 1.0 | 0.3 (4.9) | −1.6 (4.8) | 1.9 |
Notes:
a
P<0.05 for treatment difference (placebo–milnacipran) within the subgroup
b
P<0.01
c
P<0.001.
Abbreviations: BDI, Beck Depression Inventory; FIQR, Fibromyalgia Impact Questionnaire-Revised; SD, standard deviation; SF-36 PCS, 36-Item Short-Form Health Survey Physical Component Summary; VAS, visual analog scale.