Table 4.
Subgroup analysis of baseline HAM-D17 total score (≤18 vs >18) effect on all scales
| Patient characteristic | Week | Duloxetinea
|
SSRIsa
|
Treatment difference (95% CI)b |
P-value | ||
|---|---|---|---|---|---|---|---|
| n | LS mean change (95% CI) |
n | LS mean change (95% CI) |
||||
| Baseline HAM-D17 total score | ≤18 | ||||||
| BPI-SF average pain score24 | 2 | 22 | −2.1 (−2.9, −1.2) | 13 | −2.6 (−3.7, −1.4) | −0.5 (−2.0, 0.9) | 0.472 |
| 4 | 50 | −2.4 (−2.9, −1.9) | 32 | −2.8 (−3.4, −2.1) | −0.4 (−1.2, 0.5) | 0.357 | |
| 8 | 18 | −3.4 (−4.2, −2.6) | 9 | −2.9 (−3.9, −1.8) | 0.5 (−0.9, 1.9) | 0.464 | |
| 12 | 21 | −3.6 (−4.3, −2.9) | 15 | −3.4 (−4.2, −2.6) | 0.2 (−0.9, 1.3) | 0.744 | |
| HAM-D17 total score27 | 2 | 21 | −2.1 (−4.1, −0.2) | 9 | −3.1 (−6.0, −0.3) | −1.0 (−4.4, 2.4) | 0.551 |
| 4 | 49 | −5.6 (−6.8, −4.4) | 31 | −6.8 (−8.3, −5.3) | −1.2 (−3.1, 0.8) | 0.234 | |
| 8 | 15 | −6.8 (−8.5, −5.0) | 7 | −8.1 (−10.5, −5.6) | −1.3 (−4.3, 1.7) | 0.393 | |
| 12 | 15 | −8.4 (−10.6, −6.3) | 8 | −9.1 (−12.2, −6.0) | −0.7 (−4.5, 3.1) | 0.708 | |
| GAF26 | 12 | 22 | 14.2 (9.8, 18.6) | 11 | 16.7 (10.4, 23.0) | −2.5 (−10.3, 5.2) | 0.517 |
| SASS28 | 12 | 15 | 7.0 (4.4, 9.7) | 8 | 10.7 (6.8, 14.5) | −3.7 (−8.4, 1.1) | 0.127 |
| EQ-5D25 | 12 | 16 | 0.1645 (0.1065, 0.2226) | 9 | 0.2760 (0.1965, 0.3556) | −0.1115 (−0.2099, −0.0131) | 0.028d |
| Ability to work | 0 | 55 | 58.2% | 38 | 47.4% | – | 0.398 |
| 12 | 31 | 79.3% (53.0%, 92.9%) | 15 | 84.0% (54.1%, 95.9%) | 0.730 (0.147, 3.626) | 0.700 | |
| Baseline HAM-D17 total score | >18 | ||||||
| BPI-SF average pain score24 | 2 | 171 | −1.8 (−2.0, −1.5) | 164 | −1.9 (−2.2, −1.6) | −0.1 (−0.5, 0.3) | 0.595 |
| 4 | 172 | −2.8 (−3.1, −2.5) | 180 | −2.5 (−2.8, −2.2) | 0.3 (−0.2, 0.7) | 0.193 | |
| 8 | 152 | −3.6 (−3.9, −3.3) | 146 | −3.1 (−3.4, −2.7) | 0.5 (0.0, 1.0) | 0.031c | |
| 12 | 146 | −3.9 (−4.2, −3.5) | 142 | −3.4 (−3.8, −3.0) | 0.5 (−0.1, 1.0) | 0.084 | |
| HAM-D17 total score27 | 2 | 149 | −5.5 (−6.4, −4.7) | 164 | −6.3 (−7.1, −5.5) | −0.7 (−1.9, 0.4) | 0.219 |
| 4 | 157 | −10.6 (−11.7, −9.6) | 178 | −11.0 (−12.0, −10.0) | −0.4 (−1.9, 1.1) | 0.570 | |
| 8 | 133 | −15.1 (−16.2, −14.0) | 147 | −14.5 (−15.5, −13.4) | 0.6 (−0.9, 2.2) | 0.427 | |
| 12 | 128 | −17.6 (−18.8, −16.5) | 140 | −16.8 (−17.8, −15.7) | 0.9 (−0.8, 2.5) | 0.300 | |
| GAF26 | 12 | 138 | 20.9 (18.9, 22.9) | 142 | 17.8 (15.8, 19.7) | 3.1 (0.3, 6.0) | 0.031c |
| SASS28 | 12 | 132 | 9.2 (8.0, 10.5) | 138 | 8.4 (7.2, 9.7) | 0.8 (−1.1, 2.7) | 0.395 |
| EQ-5D25 | 12 | 140 | 0.3195 (0.2909, 0.3482) | 142 | 0.2879 (0.2597, 0.3162) | 0.0316 (−0.0101, 0.0733) | 0.137 |
| Ability to work | 0 | 200 | 44.0% | 200 | 36.5% | – | 0.153 |
| 12 | 146 | 88.1% (81.1%, 92.7%) | 143 | 75.5% (65.9%, 83.0%) | 2.401 (1.257, 4.584) | 0.008c | |
Notes:
For change from baseline, all values are presented as scores, except for ability to work, which is presented as a percentage.
For treatment difference, ability to work is presented as an odds ratio (values >1 favor duloxetine). All other treatment differences presented are the least squares mean change difference between treatment groups (positive values indicate favorable outcome with duloxetine; negative values indicate favorable outcome with SSRIs).
Statistically significant difference favoring duloxetine, P<0.05.
Statistically significant difference favoring the SSRIs, P<0.05. BPI-SF, higher score indicates more pain; EQ-5D, lower score indicates less healthy; GAF, lower score indicates greater severity of illness; HAM-D17, higher score indicates more depression; SASS, higher score indicates greater social adjustment.
Abbreviations: BPI-SF, Brief Pain Inventory-Short Form; CI, confidence interval; EQ-5D, EuroQol 5-dimension questionnaire for quality of life; GAF, Global Assessment of Functioning Scale; HAM-D17, 17-item Hamilton Rating Scale for Depression; LS, least squares; n, number of affected patients; SASS, Social Adaptation Self-Evaluation Scale; SSRIs, selective serotonin reuptake inhibitors.