TABLE 2.
Least-squares Mean Changes in Secondary Efficacy Measures From Baseline to Week 14 of Treatment
| Placebo N = 226 | Duloxetine N = 230 | ||||
| Baseline Mean ± SD (n) | Week 14 LS Mean Change ± SE (n) | Baseline Mean ± SD (n) | Week 14 LS Mean Change ± SE (n) | ||
| BPI-average pain | |||||
| MMRM | 5.09 ± 1.04 (226) | −1.96 ± 0.11 (200) | 5.14 ± 1.11 (230) | −2.43 ± 0.11 (209) | 0.0026‡ |
| LOCF | 5.09 ± 1.04 (226) | −1.83 ± 0.11 (226) | 5.14 ± 1.11 (230) | −2.29 ± 0.11 (230) | 0.0024‡ |
| BOCF | 5.09 ± 1.04 (226) | −1.74 ± 0.11 (226) | 5.14 ± 1.11 (230) | −2.19 ± 0.11 (230) | 0.0034‡ |
| m-BOCF | 5.09 ± 1.04 (226) | −1.78 ± 0.11 (226) | 5.14 ± 1.11 (230) | −2.23 ± 0.11 (230) | 0.0034‡ |
| BPI-other pain | |||||
| Worst pain, MMRM | 6.60 ± 1.26 (226) | −2.33 ± 0.13 (200) | 6.63 ± 1.30 (230) | −2.63 ± 0.13 (209) | 0.1010 |
| Least pain, MMRM | 3.41 ± 1.58 (226) | −1.19 ± 0.11 (200) | 3.53 ± 1.63 (230) | −1.69 ± 0.10 (209) | 0.0009‡ |
| Right now pain, MMRM | 4.87 ± 1.45 (226) | −2.03 ± 0.12 (200) | 4.76 ± 1.61 (230) | −2.42 ± 0.12 (209) | 0.0230‡ |
| Diary (24-h average pain), MMRM | 4.88 ± 1.07 (226) | −1.73 ± 0.11 (202) | 4.94 ± 1.15 (230) | −2.15 ± 0.10 (210) | 0.0049‡ |
| Diary (worst pain), MMRM | 6.30 ± 1.20 (226) | −1.91 ± 0.12 (202) | 6.32 ± 1.22 (230) | −2.25 ± 0.12 (210) | 0.0442‡ |
| BPI interference, MMRM | |||||
| Activity | 4.05 ± 2.11 (226) | −2.16 ± 0.13 (200) | 4.36 ± 2.17 (230) | −2.46 ± 0.13 (209) | 0.0874 |
| Mood | 3.31 ± 2.27 (226) | −1.83 ± 0.11 (200) | 3.43 ± 2.39 (230) | −2.15 ± 0.11 (209) | 0.0436‡ |
| Walk | 3.53 ± 2.36 (226) | −1.92 ± 0.11 (200) | 3.40 ± 2.37 (230) | −2.05 ± 0.11 (209) | 0.3902 |
| Work | 3.91 ± 2.30 (226) | −2.17 ± 0.12 (200) | 3.93 ± 2.37 (230) | −2.17 ± 0.12 (209) | 0.9910 |
| Relate | 2.10 ± 2.22 (226) | −0.98 ± 0.10 (200) | 1.91 ± 2.12 (230) | −1.02 ± 0.10 (209) | 0.7848 |
| Sleep | 2.65 ± 2.42 (226) | −1.40 ± 0.11 (200) | 2.63 ± 2.33 (230) | −1.41 ± 0.11 (209) | 0.9424 |
| Enjoy | 2.86 ± 2.41 (226) | −1.48 ± 0.11 (200) | 2.77 ± 2.30 (230) | −1.52 ± 0.11 (209) | 0.7932 |
| Average of 7 questions | 3.20 ± 1.92 (226) | −1.70 ± 0.10 (200) | 3.20 ± 1.90 (230) | −1.83 ± 0.10 (209) | 0.3761 |
| CGI severity, MMRM | 4.22 ± 0.71 (226) | −1.17 ± 0.06 (200) | 4.23 ± 0.66 (230) | −1.46 ± 0.06 (209) | 0.0019‡ |
| PGI improvement, MMRM | − | 2.76 ± 0.07 (200)* | − | 2.46 ± 0.07 (209)* | 0.0026‡ |
| RDQ-24, LOCF | 7.77 ± 4.77 (226) | −3.23 ± 0.22 (226) | 7.59 ± 4.38 (230) | −3.86 ± 0.22 (230) | 0.0439‡ |
| EQ-5D, LOCF | 0.69 ± 0.10 (226) | 0.08 ± 0.01 (226) | 0.69 ± 0.11 (230) | 0.09 ± 0.01 (230) | 0.5237 |
| SF-36, LOCF | |||||
| Physical functioning | 72.52 ± 19.53 (226) | 7.20 ± 0.80 (226) | 71.87 ± 18.30 (230) | 8.47 ± 0.79 (230) | 0.2581 |
| Role-Physical | 71.79 ± 22.07 (226) | 10.00 ± 1.16 (226) | 70.41 ± 22.28 (230) | 10.58 ± 1.15 (230) | 0.7208 |
| Bodily pain | 48.96 ± 11.76 (226) | 11.01 ± 0.95 (226) | 49.11 ± 12.24 (230) | 12.56 ± 0.94 (230) | 0.2487 |
| General health | 58.35 ± 16.78 (226) | 3.78 ± 0.86 (226) | 58.54 ± 16.53 (230) | 6.72 ± 0.85 (230) | 0.0151‡ |
| Vitality | 57.44 ± 17.35 (226) | 4.41 ± 0.97 (226) | 59.78 ± 17.61 (230) | 5.56 ± 0.97 (230) | 0.4000 |
| Social functioning | 82.25 ± 20.83 (226) | 4.77 ± 1.01 (226) | 81.79 ± 20.78 (230) | 6.40 ± 1.00 (230) | 0.2529 |
| Role-emotional | 80.57 ± 22.57 (226) | 6.18 ± 1.14 (226) | 82.14 ± 23.22 (230) | 5.78 ± 1.13 (230) | 0.8042 |
| Mental health | 72.99 ± 16.69 (226) | 2.42 ± 0.82 (226) | 73.67 ± 16.37 (230) | 5.63 ± 0.81 (230) | 0.0058‡ |
| WPAI, LOCF† | |||||
| Work time missed | 0.01 ± 0.05 (140) | 0.02 ± 0.01 (143) | 0.02 ± 0.08 (135) | −0.01 ± 0.01 (140) | 0.0460‡ |
| Impairment at work | 0.31 ± 0.24 (140) | −0.09 ± 0.02 (143) | 0.29 ± 0.24 (136) | −0.13 ± 0.02 (140) | 0.0753 |
| Work productivity loss | 0.31 ± 0.25 (140) | −0.09 ± 0.02 (143) | 0.30 ± 0.24 (135) | −0.13 ± 0.02 (140) | 0.0795 |
| Work activity impairment | 0.35 ± 0.22 (226) | −0.12 ± 0.01 (226) | 0.34 ± 0.23 (230) | −0.14 ± 0.01 (230) | 0.1466 |
BOCF indicates Baseline Observed Carried Forward; BPI, Brief Pain Inventory; CGI, Clinical Global Impressions; EQ-5D, European QOL Questionnaire–5 Dimension; LOCF, Last Observation Carried Forward; m-BOCF, modified BOCF; MMRM, mixed-effects model repeated measures; PGI, Patient's Global Impression; RDQ-24, Roland-Morris Disability Questionnaire; SF-36, 36-Item Short-Form Health Survey; WPAI, Work Productivity and Activity Impairment Instrument.
*LS mean ± SE at week 14.
†Work time missed, impairment at work, and work productivity loss were assessed only in patients who were actively employed throughout the examination period.
‡Indicates statistical significance.