Table 1.
Baseline Characteristics of Study Populations (Safety Analysis Set, n=612)
| Category | Number | Statistic |
|---|---|---|
| Female | 612 | 432 (70.64) |
| Age, years | 607 | 44.95 (11.97) |
| <30 | 72 (11.84) | |
| ≥30 and <40 | 140 (23.03) | |
| ≥40 and <50 | 191 (31.41) | |
| ≥50 and <60 | 135 (22.24) | |
| ≥60 | 69 (11.35) | |
| Weight, kg | 608 | 86.30 (14.93) |
| BMI, kg/m2 | 612 | 32.14 (3.83) |
| Obesity classa | 612 | |
| Class I | 139 (22.68) | |
| Class II | 361 (58.99) | |
| Class III | 112 (18.27) | |
| Smoking history | 610 | |
| Non-smoker | 495 (81.01) | |
| Ex-smoker | 33 (5.41) | |
| Current-smoker | 82 (13.42) | |
| Alcohol consumption (Yes) | 610 | 183 (30.00) |
| Comorbidityb | 612 | |
| Hypertension | 207 (33.82) | |
| Diabetes | 129 (21.08) | |
| Dyslipidemia | 242 (39.54) | |
| Chronic liver failure | 63 (10.29) | |
| Chronic kidney disease | 6 (0.98) | |
| Arthritis | 24 (3.92) | |
| Malignancy | 13 (2.12) | |
| Hypothyroidism | 19 (3.10) | |
| Hyperthyroidism | 4 (0.65) | |
| Previous anti-obesity drug history | 612 | 107 (17.46) |
| Dose of NBSR (milligram per day) | 612 | |
| NBSR 8/90 | 98 (15.99) | |
| NBSR 16/180 | 176 (28.71) | |
| NBSR 24/270 | 52 (8.48) | |
| NBSR 32/360 | 286 (46.66) |
Notes: Values are expressed as either number (percentage) or mean ± standard deviation. aObesity is defined as obese class I (25 kg/m2 ≤ BMI < 30 kg/m2), obese class II (30 kg/m2 ≤ BMI < 35 kg/m2), or obesity class III (BMD ≥ 35 kg/m2). bComorbidity was reported by self-report of patients.
Abbreviations: BMI, body mass index; NBSR, naltrexone SR/bupropion SR combination.