Table 2. Adjusted Mean changes in SF-36, EQ-5D and DrInC scores from baseline to week 12 and week 24 in patients with a high drinking risk level (MMRM, target efficacy population).
| Change from baseline to Week 12 | Difference to Placebo baseline to Week 12 | Change from baseline to Week 24 | Difference to Placebo baseline to Week 24 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| N | Mean ± SE | Mean ± SE | 95% CI | p-value | N | Mean ± SE | Mean ± SE | 95% CI | p-value | ||
| SF-36 MCS score | PLA | 268 | 2.10 ± 0.73 | 218 | 2.65 ± 0.78 | ||||||
| NMF | 275 | 4.31 ± 0.70 | 2.21 ± 0.78 | [0.68; 3.74] | 0.0047 | 184 | 5.74 ± 0.79 | 3.09 ± 0.92 | [1.29; 4.89] | 0.0008 | |
| SF-36 PCS score | PLA | 268 | 0.52 ± 0.45 | 218 | 1.12 ± 0.47 | ||||||
| NMF | 275 | 1.61 ± 0.43 | 1.09 ± 0.48 | [0.15; 2.03] | 0.0232 | 184 | 2.35 ± 0.48 | 1.23 ± 0.55 | [0.15; 2.31] | 0.0259 | |
| EQ-5D Utility Index score | PLA | 278 | 0.01 ± 0.01 | 222 | 0.03 ± 0.01 | ||||||
| NMF | 279 | 0.04 ± 0.01 | 0.03 ± 0.01 | [0.01; 0.06] | 0.0185 | 188 | 0.06 ± 0.01 | 0.03 ± 0.02 | [0.00; 0.06] | 0.0445 | |
| EQ-5D Health State score | PLA | 274 | 2.43 ± 1.10 | 221 | 3.13 ± 1.19 | ||||||
| NMF | 276 | 5.18 ± 1.07 | 2.75 ± 1.17 | [0.45; 5.05] | 0.0191 | 189 | 6.60 ± 1.20 | 3.46 ± 1.38 | [0.75; 6.17] | 0.0124 | |
| DrInC Total score a | PLA | 280 | -11.95 ± 1.23 | 226 | -14.64 ± 1.30 | ||||||
| NMF | 282 | -13.25 ± 1.20 | -1.30 ± 1.31 | [-3.86; 1.26] | 0.3200 | 189 | -17.86 ± 1.31 | -3.22 ± 1.47 | [-6.12; -0.33] | 0.0292 | |
a A lower score indicates fewer alcohol-related problems
DrInC, drinker inventory of consequences; EQ-5D, EuroQoL-5 dimensions; MCS, mental component summary; MMRM = Mixed Model Repeated Measures; NMF = nalmefene; PCS, physical component summary; PLA = placebo; SF-36, Short-Form health survey-36.