Secondary pain and PGIC assessments (OC).
| Placebo, n = 223 | Milnacipran 100 mg/day, n = 224 | Milnacipran 200 mg/day, n = 441 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Variablea | n | Mean (SEM) | n | Mean (SEM) | LS Mean Difference (95% CI) | p | n | Mean (SEM) | LS Mean Difference (95% CI) | p |
| 15 Weeks | ||||||||||
| PED 24-h recall pain scores (weekly average) | 164 | 49.55 (1.75) | 144 | 44.50 (1.97) | –5.03 (–10.33, 0.27) | 0.063 | 276 | 43.36 (1.39) | –5.80 (–9.93, –1.67) | 0.006 |
| PED real-time pain scores (weekly average) | 164 | 48.66 (1.81) | 143 | 44.19 (1.97) | –4.11 (–9.28, 1.06) | 0.119 | 277 | 42.67 (1.40) | –5.48 (–9.57, –1.39) | 0.009 |
| PED weekly recall pain scores | 163 | 51.37 (1.85) | 142 | 46.92 (2.00) | –4.53 (–10.05, 1.00) | 0.108 | 273 | 45.58 (1.49) | –5.47 (–10.04, –0.90) | 0.019 |
| Paper VAS 24-h recall pain scores | 161 | 50.61 (2.19) | 140 | 45.26 (2.42) | –4.64 (–11.36, 2.09) | 0.175 | 264 | 42.86 (1.76) | –5.99 (–11.46, –0.51) | 0.032 |
| Paper VAS 7-day recall pain scores | 161 | 51.73 (2.06) | 140 | 47.97 (2.38) | –3.71 (–10.29, 2.87) | 0.268 | 264 | 44.27 (1.73) | –6.07 (–11.39, –0.74) | 0.026 |
| PGIC | 161 | 3.09 (0.10) | 140 | 2.68 (0.11) | –0.40 (–0.69, –0.10) | 0.009 | 264 | 2.59 (0.08) | –0.42 (–0.67, –0.18) | < 0.001 |
| 27 Weeks | ||||||||||
| PED 24-h recall pain scores (weekly average) | 128 | 50.86 (2.11) | 115 | 43.31 (2.21) | –8.01 (–14.13, –1.88) | 0.011 | 204 | 43.42 (1.77) | –7.11 (–12.53, –1.70) | 0.010 |
| PED real-time pain scores (weekly average) | 126 | 50.33 (2.21) | 116 | 43.43 (2.20) | –6.72 (–12.82, –0.62) | 0.031 | 204 | 42.39 (1.77) | –6.91 (–12.33, –1.49) | 0.013 |
| PED weekly recall pain scores | 123 | 52.24 (2.11) | 110 | 46.65 (2.35) | –6.48 (–13.00, 0.03) | 0.051 | 195 | 45.86 (1.88) | –5.62 (–11.46, 0.21) | 0.059 |
| Paper VAS 24-h recall pain scores | 145 | 52.36 (2.33) | 128 | 44.09 (2.59) | –8.31 (–15.24, –1.39) | 0.019 | 239 | 42.84 (1.93) | –7.92 (–14.07, –1.76) | 0.012 |
| Paper VAS 7-day recall pain scores | 145 | 53.93 (2.30) | 128 | 44.58 (2.47) | –10.33 (–17.22, –3.45) | 0.003 | 239 | 44.97 (1.91) | –7.79 (–13.92, –1.66) | 0.013 |
| PGIC | 145 | 3.07 (0.11) | 128 | 2.78 (0.12) | –0.30 (–0.63, 0.03) | 0.071 | 239 | 2.52 (0.08) | –0.48 (–0.75, –0.21) | < 0.001 |
↵a Unless otherwise indicated, comparisons to placebo are based on least square (LS) mean change from baseline (ANCOVA), with treatment group and study center as factors and baseline value as covariate. OC: observed cases; PED: patient experience diary; PGIC: Patient Global Impression of Change; SEM: standard error of the mean; VAS: visual analog scale.