TABLE 2.
Change From Baseline and Screening in EQ-5D and SF-36v2 Scores at Week 25 Based on Mixed Model for Repeated Measures
| Placebo | BUP-XR 300/100 mg | Difference Between BUP-XR 300/100 mg and Placebo | BUP-XR 300/300 mg | Difference Between BUP-XR 300/300 mg and Placebo | ||||||
| Measure | LS mean (SE) | P | LS mean (SE) | P | LS mean difference (SE) | P | LS mean (SE) | P | LS mean difference (SE) | P |
| Change from baseline to week 25 | ||||||||||
| EQ-5D | ||||||||||
| Index | −0.05 (0.02) | 0.013 | −0.01 (0.01) | 0.502 | 0.04 (0.02) | 0.053 | 0.02 (0.01) | 0.205 | 0.06 (0.02) | 0.003 |
| VAS | −3.6 (2.2) | 0.090 | 4.1 (1.2) | <0.001 | 7.7 (2.5) | 0.002 | 2.2 (1.2) | 0.057 | 5.9 (2.5) | 0.017 |
| SF-36v2 | ||||||||||
| Physical component summary | −1.8 (0.9) | 0.045 | 1.4 (0.5) | 0.009 | 3.2 (1.0) | 0.002 | 1.9 (0.5) | <0.001 | 3.8 (1.0) | <0.001 |
| Mental component summary | 1.9 (1.2) | 0.133 | 4.2 (0.7) | <0.001 | 2.4 (1.4) | 0.097 | 4.5 (0.7) | <0.001 | 2.6 (1.4) | 0.063 |
| Physical functioning | −1.8 (2.2) | 0.413 | 0.6 (1.3) | 0.638 | 2.4 (2.5) | 0.333 | 3.6 (1.3) | 0.006 | 5.4 (2.5) | 0.030 |
| Role physical | −1.0 (2.9) | 0.737 | 4.9 (1.6) | 0.003 | 5.9 (3.3) | 0.075 | 6.6 (1.6) | <0.001 | 7.6 (3.3) | 0.022 |
| Bodily pain | 1.5 (3.3) | 0.639 | 8.1 (2.1) | <0.001 | 6.6 (3.5) | 0.060 | 8.8 (2.1) | <0.001 | 7.2 (3.5) | 0.038 |
| General health | −6.6 (2.6) | 0.011 | 5.6 (1.5) | <0.001 | 12.2 (2.9) | <0.001 | 5.8 (1.4) | <0.001 | 12.4 (2.9) | <0.001 |
| Vitality | −0.1 (2.8) | 0.985 | 10.7 (1.7) | <0.001 | 10.8 (3.1) | <0.001 | 10.4 (1.7) | <0.001 | 10.4 (3.1) | <0.001 |
| Social functioning | 2.6 (3.2) | 0.415 | 8.4 (1.9) | <0.001 | 5.8 (3.5) | 0.102 | 10.2 (1.9) | <0.001 | 7.6 (3.5) | 0.030 |
| Role emotional | 1.8 (2.7) | 0.491 | 3.6 (1.5) | 0.016 | 1.7 (3.1) | 0.572 | 5.6 (1.5) | <0.001 | 3.8 (3.0) | 0.215 |
| Mental health | 4.7 (2.6) | 0.067 | 8.8 (1.5) | <0.001 | 4.1 (2.9) | 0.161 | 9.6 (1.5) | <0.001 | 4.8 (2.9) | 0.095 |
| Change from screening to week 25 | ||||||||||
| EQ-5D | ||||||||||
| Index | 0.06 (0.02) | 0.002 | 0.10 (0.01) | <0.001 | 0.04 (0.02) | 0.050 | 0.12 (0.01) | <0.001 | 0.06 (0.02) | 0.005 |
| VAS | 9.1 (2.3) | <0.001 | 16.7 (1.4) | <0.001 | 7.6 (2.5) | 0.002 | 15.3 (1.4) | <0.001 | 6.3 (2.5) | 0.011 |
| SF-36v2 | ||||||||||
| Physical component summary | 3.2 (0.9) | <0.001 | 5.5 (0.6) | <0.001 | 2.3 (1.0) | 0.025 | 6.6 (0.6) | <0.001 | 3.4 (1.0) | 0.001 |
| Mental component summary | 5.4 (1.3) | <0.001 | 9.8 (0.8) | <0.001 | 4.4 (1.4) | 0.002 | 10.1 (0.8) | <0.001 | 4.7 (1.4) | <0.001 |
| Physical functioning | 10.2 (2.6) | <0.001 | 10.0 (1.6) | <0.001 | −0.2 (2.8) | 0.941 | 14.7 (1.6) | <0.001 | 4.5 (2.8) | 0.111 |
| Role physical | 9.7 (3.0) | 0.001 | 17.0 (1.8) | <0.001 | 7.3 (3.3) | 0.027 | 20.2 (1.8) | <0.001 | 10.4 (3.3) | 0.002 |
| Bodily pain | 14.2 (3.2) | <0.001 | 21.1 (2.0) | <0.001 | 6.9 (3.4) | 0.040 | 22.1 (2.0) | <0.001 | 7.9 (3.4) | 0.020 |
| General health | 4.9 (2.5) | 0.053 | 17.6 (1.5) | <0.001 | 12.7 (2.9) | <0.001 | 17.7 (1.5) | <0.001 | 12.8 (2.8) | <0.001 |
| Vitality | 9.4 (2.8) | 0.001 | 21.9 (1.7) | <0.001 | 12.5 (3.1) | <0.001 | 22.2 (1.7) | <0.001 | 12.8 (3.1) | <0.001 |
| Social functioning | 14.7 (3.2) | <0.001 | 23.2 (1.9) | <0.001 | 8.5 (3.5) | 0.015 | 25.6 (1.9) | <0.001 | 10.9 (3.5) | 0.002 |
| Role emotional | 9.3 (2.8) | <0.001 | 15.6 (1.7) | <0.001 | 6.3 (3.0) | 0.039 | 17.4 (1.7) | <0.001 | 8.1 (3.0) | 0.008 |
| Mental health | 11.4 (2.6) | <0.001 | 18.3 (1.5) | <0.001 | 6.8 (2.8) | 0.017 | 19.3 (1.5) | <0.001 | 7.8 (2.8) | 0.006 |
BUP-XR, buprenorphine extended-release monthly injection, for subcutaneous use [CIII]; LS, least squares; SF-36v2, 36-Item Short Form Health Survey, Version 2; VAS, visual analog scale.