Mean (SD) changes in pain, fatigue, and sleep scores from baseline (BSL) lead-in and BSL extension at the 1-year endpoint. Data are last observation carried forward (LOCF)/observed case (OC), in-patients receiving placebo (PBO) or milnacipran (MLN) 100, 150, or 200 mg/day.
| Characteristic | PBO:MLN100, n = 91 | PBO:MLN150, n = 92 | PBO:MLN200, n = 87 | MLN200:MLN200, n = 198 |
|---|---|---|---|---|
| Pain | ||||
| Weekly-recall pain change from | ||||
| BSL lead-in | –20.9 (25.5)/–26.0 (24.5) | –27.9 (26.9)/–36.4 (23.4) | –26.6 (26.8)/–34.2 (24.3) | –26.5 (29.0)/–31.5 (28.3) |
| BSL extension | –11.6 (22.6)/–17.9 (20.6) | –13.5 (22.5)/–20.0 (23.2) | –15.3 (22.5)/–21.3 (22.5) | –14.7 (24.2)/–19.6 (23.5) |
| 24-hour-recall pain change from | ||||
| BSL lead-in | –23.3 (26.6)/–29.9 (23.9) | –25.7 (26.9)/–34.2 (24.9) | –27.5 (26.2)/–34.2 (27.2) | –26.9 (27.6)/–31.4 (27.0) |
| BSL extension | –14.3 (22.7)/–20.7 (20.1) | –14.2 (23.6)/–20.9 (24.9) | –16.6 (22.1)/–23.6 (23.2) | –14.1 (23.5)/–18.2 (23.9) |
| BPI pain intensity change from | ||||
| BSL lead-in | –1.47 (2.24)/–2.07 (2.16) | –1.82 (2.02)/–2.41 (1.95) | –1.79 (1.98)/–2.22 (2.12) | –1.95 (2.34)/–2.42 (2.18) |
| BSL extension | –0.98 (1.95)/–1.61 (1.55) | –1.18 (1.98)/–1.78 (1.80) | –1.17 (1.82)/–1.71 (1.84) | –1.21 (1.91)/–1.62 (1.87) |
| BPI pain interference change from | ||||
| BSL lead-in | –1.31 (2.19)/–1.64 (1.90) | –1.35 (2.41)/–1.78 (2.53) | –1.92 (2.07)/–2.23 (2.25) | –1.68 (2.42)/–2.13 (2.27) |
| BSL extension | –0.57 (1.87)/–1.08 (1.66) | –0.41 (1.86)/–0.85 (1.85) | –0.93 (1.78)/–1.34 (1.85) | –0.91 (1.96)/–1.25 (1.88) |
| Fatigue | ||||
| Total MFI change from | ||||
| BSL lead-in | –3.93 (16.25)/–5.22 (16.97) | –6.69 (14.39)/–9.07 (15.54) | –6.44 (16.81)/–8.68 (17.86) | –6.71 (16.27)/–8.54 (15.97) |
| BSL extension | –2.77 (13.93)/–4.20 (15.76) | –2.32 (13.25)/–5.30 (12.07) | –2.25 (13.57)/–4.98 (13.35) | –3.25 (12.57)/–4.99 (11.83) |
| Weekly-recall fatigue change from | ||||
| BSL lead-in | –15.8 (27.1)/–19.0 (28.0) | –22.0 (30.1)/–27.3 (28.8) | –20.9 (23.4)/–28.6 (22.5) | –20.4 (30.4)/–25.2 (30.0) |
| BSL extension | –8.3 (22.8)/–13.7 (19.7) | –14.2 (24.9)/–18.5 (25.3) | –9.6 (18.9)/–14.5 (19.5) | –10.3 (25.3)/–13.2 (24.0) |
| Sleep | ||||
| Weekly-recall sleep change from | ||||
| BSL lead-in | –11.9 (26.5)/–17.2 (27.9) | –21.1 (28.6)/–27.4 (28.9) | –20.2 (24.6)/–26.9 (24.9) | –19.9 (30.7)/–24.9 (29.5) |
| BSL extension | –6.6 (24.0)/–11.0 (21.6) | –13.6 (27.1)/–18.7 (29.0) | –9.2 (17.8)/–13.4 (17.2) | –10.9 (26.7)/–14.4 (24.9) |
BPI: Brief Pain Inventory.