Table 2.
Subgroup analysis of depressive episode (first vs ≥ second) 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) |
||||
| First episode of depression | |||||||
| BPI-SF average pain score24 | 2 | 109 | −1.9 (−2.2, −1.6) | 100 | −2.0 (−2.3, −1.6) | −0.1 (−0.6, 0.4) | 0.741 |
| 4 | 123 | −3.0 (−3.3, −2.6) | 124 | −2.6 (−2.9, −2.2) | 0.4 (−0.1, 0.9) | 0.086 | |
| 8 | 94 | −3.8 (−4.2, −3.4) | 88 | −3.3 (−3.6, −2.9) | 0.6 (0.0, 1.1) | 0.045c | |
| 12 | 90 | −4.3 (−4.7, −4.0) | 88 | −3.5 (−3.9, −3.2) | 0.8 (0.2, 1.3) | 0.005c | |
| HAM-D17 total score27 | 2 | 87 | −6.0 (−0.7, −0.5) | 95 | −6.3 (−7.2, −5.3) | −0.3 (−1.7, 1.1) | 0.678 |
| 4 | 108 | −11.0 (−12.2, −9.9) | 119 | −11.1 (−12.2, −10.0) | 0.0 (−1.7, 1.6) | 0.959 | |
| 8 | 76 | −15.5 (−16.9, −14.1) | 85 | −14.0 (−15.3, −12.7) | 1.5 (−0.4, 3.5) | 0.116 | |
| 12 | 70 | −18.3 (−19.7, −17.0) | 80 | −16.0 (−17.3, −14.8) | 2.3 (0.4, 4.2) | 0.015c | |
| GAF26 | 12 | 80 | 23.3 (20.8, 25.7) | 84 | 19.2 (16.9, 21.6) | 4.0 (0.6, 7.5) | 0.022c |
| SASS28 | 12 | 75 | 10.7 (9.2, 12.3) | 79 | 9.9 (8.4, 11.4) | 0.9 (−1.3, 3.0) | 0.435 |
| EQ-5D25 | 12 | 79 | 0.3527 (0.3178, 0.3875) | 82 | 0.3000 (0.2661, 0.3339) | 0.0526 (0.0031, 0.1022) | 0.037c |
| Ability to work | 0 | 139 | 53.2% | 136 | 40.4% | – | 0.040c |
| 12 | 98 | 88.4% (79.6%, 93.7%) | 89 | 75.9% (65.1%, 84.2%) | 2.418 (1.143, 5.117) | 0.021c | |
| Second or higher episode of depression | |||||||
| BPI-SF average pain score | 2 | 52 | −1.8 (−2.4, −1.3) | 49 | −2.0 (−2.5, −1.4) | −0.1 (−0.9, 0.6) | 0.715 |
| 4 | 66 | −2.5 (−3.0, −2.0) | 59 | −2.4 (−2.9, −1.8) | 0.1 (−0.6, 0.9) | 0.719 | |
| 8 | 42 | −3.4 (−3.9, −2.8) | 45 | −2.6 (−3.1, −2.0) | 0.8 (0.0, 1.6) | 0.065 | |
| 12 | 47 | −3.3 (−4.0, −2.7) | 46 | −3.2 (−3.9, −2.6) | 0.1 (−0.8, 1.0) | 0.823 | |
| HAM-D17 total score27 | 2 | 40 | −3.9 (−5.5, −2.3) | 45 | −5.4 (−6.9, −3.9) | −1.5 (−3.7, 0.8) | 0.192 |
| 4 | 53 | −8.2 (−9.9, −6.5) | 56 | −8.4 (−10.0, −6.8) | −0.2 (−2.7, 2.3) | 0.873 | |
| 8 | 28 | −12.0 (−13.9, −10.2) | 41 | −12.0 (−13.7, −10.4) | 0.0 (−2.6, 2.5) | 0.982 | |
| 12 | 34 | −13.1 (−15.3, −10.9) | 39 | −13.5 (−15.5, −11.5) | −0.4 (−3.4, 2.7) | 0.802 | |
| GAF26 | 12 | 46 | 17.3 (13.9, 20.7) | 46 | 16.4 (13.0, 19.7) | 0.9 (−4.0, 5.9) | 0.714 |
| SASS28 | 12 | 37 | 8.2 (6.0, 10.5) | 45 | 6.9 (4.8, 9.0) | 1.3 (−1.9, 4.5) | 0.410 |
| EQ-5D25 | 12 | 42 | 0.2267 (0.1760, 0.2775) | 45 | 0.2259 (0.1768, 0.2749) | 0.0009 (−0.0724, 0.0742) | 0.981 |
| Ability to work | 0 | 79 | 32.9% | 76 | 28.9% | – | 0.607 |
| 12 | 51 | 81.0% (67.1%, 89.9%) | 47 | 75.4% (55.8%, 88.2%) | 1.386 (0.495, 3.883) | 0.534 | |
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. 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.