Table 1.
Baseline characteristics
| Characteristic | USE-PACT | USE-AM | |
|---|---|---|---|
| Safety set (N = 700) | Efficacy set (N = 256) | (N = 486) | |
| Sex (male/female); n (%) | 471 (67.3)/229 (32.7) | 167 (65.2)/89 (34.8) | 338 (69.5)/148 (30.5) |
| Age (years) | |||
| Mean ± SD Median [p25%, p75%] |
48.3 ± 10.8 48 [42, 56] |
48.9 ± 10.9 48 [42, 57] |
49.5 ± 11.6 50 [41, 57] |
| Age of onset of alcohol consumption problems; n (%) | |||
| <18 years 18–24 years 25–34 years 35–44 years 45–54 years 55–64 years ≥65 years |
124 (17.7) 166 (23.7) 162 (23.1) 144 (20.6) 73 (10.4) 26 (3.7) 3 (0.4) |
49 (19.1) 56 (21.9) 49 (19.1) 60 (23.4) 29 (11.3) 13 (5.1) 0 (0.0) |
N/A |
| Number patients with ≥1 psychiatric co-morbidity, n (%)a | 392 (56.0) | 162 (63.3) | 111 (22.8) |
| Depression Anxiety Bipolar disorder |
235 (33.6) 129 (18.4) 42 (6.0) |
97 (37.9) 54 (21.1) 23 (9.0) |
41 (8.4) 5 (1.0) 19 (3.9) |
| Total alcohol consumption (g/day) | |||
| Mean ± SD Median [p25%, p75%] |
66.0 ± 57.9 54.3 [27.1; 85.7] |
64.9 ± 55.8 52.7 [28.6; 89.3] |
N/A |
| Number of heavy drinking days (per 4 weeks) Mean ± SD Median [p25%, p75%] |
16.1 ± 10.2 18 [6; 28] |
16.2 ± 10.5 17 [6; 28] |
N/A |
| Current concomitant medications; n (%) | |||
| Any current treatment Gastrointestinal system/metabolism Cardiovascular system Central nervous System Psycholeptic Psychoanaleptic Antiepileptic Addiction Analgesic |
544 (77.7) 124 (17.7) 97 (13.9) 488 (69.7) 415 (59.3) 280 (40.0) 64 (9.1) 21 (3.0) 18 (2.6) |
208 (81.3) 45 (17.6) 36 (14.1) 188 (73.4) 164 (64.1) 118 (46.1) 36 (14.1) 8 (3.1) 9 (3.5) |
358 (73.7) 87 (17.9) 85 (17.5) 303 (62.3) 249 (51.2) 147 (30.2) 24 (4.9) 12 (2.5) 49 (10.1) |
| History of prior pharmacological treatment for alcohol, n (%) Acamprosate Baclofen Naltrexone Disulfiram |
362 (51.7) 242 (34.6) 134 (19.1) 111 (15.9) 59 (8.4) |
131 (51.2) 85 (33.2) 47 (18.4) 37 (14.5) 27 (10.5) |
146 (30.0) 69 (14.2) 71 (14.6) 36 (7.4) 12 (2.5) |
| History of prior treatment goal, n (%) | |||
| Abstinence Abstinence and reduction Reduction |
221 (31.6) 215 (30.7) 169 (24.1) |
83 (32.4) 78 (30.5) 55 (21.5) |
N/A |
aComorbidities in USE-AM were limited to those classified as long-term disease registrations