Table 3.
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 BPI-SF average pain score | ≤6 | ||||||
BPI-SF average pain score24 | 2 | 137 | −1.6 (−1.9, −1.3) | 141 | −1.6 (−1.9, −1.4) | −0.1 (−0.5, 0.3) | 0.734 |
4 | 158 | −2.3 (−2.6, −2.0) | 171 | −2.2 (−2.4, −1.9) | 0.2 (−0.3, 0.6) | 0.420 | |
8 | 121 | −3.0 (−3.3, −2.6) | 129 | −2.7 (−3.0, −2.3) | 0.3 (−0.2, 0.8) | 0.213 | |
12 | 117 | −3.3 (−3.6, −2.9) | 122 | −3.1 (−3.4, −2.7) | 0.2 (−0.3, 0.7) | 0.369 | |
HAM-D17 total score27 | 2 | 110 | −5.2 (−6.1, −4.3) | 134 | −6.1 (−6.9, −5.3) | −0.9 (−2.2, 0.3) | 0.125 |
4 | 139 | −9.7 (−10.8, −8.7) | 162 | −10.8 (−11.7, −9.9) | −1.1 (−2.5, 0.4) | 0.143 | |
8 | 98 | −13.9 (−15.1, −12.8) | 124 | −14.1 (−15.1, −13.0) | −0.1 (−1.7, 1.4) | 0.884 | |
12 | 93 | −16.4 (−17.5, −15.2) | 112 | −16.3 (−17.3, −15.2) | 0.1 (−1.5, 1.7) | 0.879 | |
GAF26 | 12 | 110 | 20.6 (18.5, 22.7) | 121 | 18.8 (16.8, 20.8) | 1.8 (−1.2, 4.8) | 0.249 |
SASS28 | 12 | 97 | 8.9 (7.5, 10.2) | 114 | 8.8 (7.6, 10.0) | 0.1 (−1.8, 1.9) | 0.937 |
EQ-5D25 | 12 | 104 | 0.2926 (0.2617, 0.3235) | 119 | 0.2816 (0.2529, 0.3104) | 0.0109 (−0.0327, 0.0546) | 0.622 |
Ability to work | 0 | 177 | 48.6% | 185 | 40.5% | – | 0.139 |
12 | 126 | 85.8% (77.3%, 91.5%) | 123 | 81.5% (72.3%, 88.1%) | 1.374 (0.689, 2.740) | 0.367 | |
Baseline BPI-SF average pain score | >6 | ||||||
BPI-SF average pain score24 | 2 | 72 | −2.4 (−2.9, −1.9) | 43 | −2.7 (−3.4, −2.1) | −0.3 (−1.1, 0.5) | 0.485 |
4 | 78 | −4.0 (−4.5, −3.5) | 48 | −3.5 (−4.1, −2.8) | 0.5 (−0.3, 1.3) | 0.219 | |
8 | 61 | −5.0 (−5.6, −4.5) | 35 | −4.1 (−4.8, −3.4) | 0.9 (0.0, 1.9) | 0.051 | |
12 | 62 | −5.2 (−5.8, −4.6) | 43 | −4.4 (−5.1, −3.6) | 0.8 (−0.2, 1.8) | 0.109 | |
HAM-D17 total score27 | 2 | 60 | −5.3 (−6.7, −3.9) | 39 | −5.8 (−7.5, −4.1) | −0.5 (−2.7, 1.7) | 0.673 |
4 | 67 | −10.7 (−12.3, −9.1) | 47 | −9.7 (−11.7, −7.8) | 1.0 (−1.6, 3.5) | 0.461 | |
8 | 50 | −14.8 (−16.6, −12.9) | 30 | −12.5 (−14.8, −10.2) | 2.2 (−0.8, 5.2) | 0.140 | |
12 | 50 | −17.0 (−19.0, −15.0) | 36 | −14.5 (−16.9, −12.1) | 2.5 (−0.7, 5.7) | 0.125 | |
GAF26 | 12 | 55 | 19.5 (16.4, 22.6) | 40 | 16.5 (12.8, 20.3) | 3.0 (−2.0, 8.0) | 0.238 |
SASS28 | 12 | 56 | 9.7 (7.5, 11.9) | 40 | 8.8 (6.1, 11.4) | 0.9 (−2.6, 4.5) | 0.604 |
EQ-5D25 | 12 | 58 | 0.3316 (0.2873, 0.3758) | 39 | 0.2960 (0.2410, 0.3510) | 0.0355 (−0.0365, 0.1075) | 0.330 |
Ability to work | 0 | 96 | 41.7% | 65 | 32.3% | – | 0.250 |
12 | 65 | 84.6% (73.8%, 91.5%) | 44 | 67.8% (47.0%, 83.3%) | 2.614 (1.065, 6.416) | 0.036c |
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.