Table 1. Baseline characteristics/demographics, including patient-reported outcomes, in patients with a high drinking risk level (target efficacy population) [adapted from [27]].
| High drinking risk level at screening and randomization (target population) | |||
|---|---|---|---|
| Placebo (n = 332) | Nalmefene (n = 335) | TOTAL (n = 667) | |
| Race, Caucasian | 329 (99.1%) | 333 (99.4%) | 662(99.3%) |
| Sex, Male | 216 (65.1%) | 223 (66.6%) | 439(65.8%) |
| Age (years) | 48.7 (10.5) | 48.4 (10.5) | 48.5 ± 10.5 |
| Body Mass Index (kg/m2) | 26.1 (4.4) | 26.0 (4.8) | 26.0 ± 4.6 |
| Age at onset of problem drinking (years) | 35.1 (11.6) | 35.6 (12.3) | 35.3 ± 11.9 |
| Total monthly heavy drinking days (days) | 22.4 (6.0) | 22.9 (5.9) | 22.6 ± 5.9 |
| Total alcohol consumption (g/day) | 103.3 (44.5) | 107.7 (45.5) | 105.5 ± 45.0 |
| Clinical Global Impression—Severity of Illness | 4.3 (1.4) | 4.3 (1.4) | 4.3 ± 1.4 |
| Drinker inventory of consequences (DrInC) total score | 42.2 (22.2) | 41.1 (22.3) | 41.6 ± 22.2 |
| Alcohol dependence scale total score | 13.3 (5.7) | 14.0 (6.0) | 13.7 ± 5.8 |
| Current smoker | 192 (57.8%) | 184 (54.9%) | 376(56%) |
| Living alone | 99 (29.8%) | 88 (26.3%) | 187(28%) |
| Previously treated for alcohol dependence | 112 (33.7%) | 105 (31.3%) | 217(32.5%) |
| Previously treated for alcohol withdrawal symptoms | 59 (17.8%) | 49 (14.6%) | 108(16.2%) |
| Family history of alcohol problems | 209 (63.0%) | 211 (63.0%) | 420(63.0%) |
Data are mean (SD) or number of patients (%).
SD, standard deviation.