Table 1.
Baseline characteristics and clinical variables of enrolled patients.
| Study | Trial B (n = 67) |
Trial A (n = 73) |
|
|---|---|---|---|
| Treatment | Placebo (n = 34) |
Anakinra (n = 33) |
Anakinra and dexamethasone |
| General characteristics | |||
| Age—years | 55 (43, 65) | 55 (45, 67) | 56 (48, 62) |
| Sex, female—% | 0 (0%) | 0 (0%) | 37 (51%) |
| Body weight—kg | 114 (102, 124) | 113 (107, 122) | 106 (96, 123) |
| Body mass index—kg/m2 | 36.2 (34.0, 39.5) | 37.3 (34.4, 39.4) | 36.3 (33.3, 40.7) |
| < 35 | 11 (32%) | 10 (30%) | 30 (41%) |
| 35–40 | 18 (53%) | 17 (52%) | 19 (26%) |
| > 40 | 5 (15%) | 6 (18%) | 24 (33%) |
| Systolic blood pressure—mmHg | 132 (123, 139) | 136 (130, 147) | 139 (129, 152) |
| Diastolic blood pressure—mmHg | 85.3 (78, 94) | 89.7 (84, 93) | 85.0 (77, 91) |
| Comorbidities | |||
| Diabetes mellitus | 7 (21%) | 9 (27%) | 47 (64%) |
| Diet | 0 (0%) | 1 (11%) | 5 (11%) |
| Oral drug | 6 (86%) | 8 (89%) | 39 (83%) |
| Insulin (alone or with oral drug) | 1 (14%) | 0 (0%) | 3 (6%) |
| Hypertension | 21 (62%) | 26 (79%) | 56 (77%) |
| Antihypertensive medication | 14 (67%) | 16 (62%) | 53 (91%) |
| Dyslipidemia | 29 (85%) | 28 (85%) | 58 (79%) |
| Statin treatment | 7 (24%) | 11 (39%) | 35 (58%) |
| Smoking status | 19 (56%) | 23 (70%) | 38 (52%) |
| Packyears | 7.5 (0.0, 20.0) | 15.0 (0.0, 27.0) | 0.0 (0.0, 35.0) |
| Laboratory values | |||
| HbA1c—% | 5.8 (5.4, 6.1) | 5.9 (5.5, 6.3) | 6.5 (5.8, 8.1) |
| Total cholesterol—mmol/L | 4.7 (4.0, 5.5) | 5.3 (3.8, 5.7) | 4.6 (3.6, 5.3) |
| LDL cholesterol—mmol/L | 2.8 (2.1, 3.8) | 3.1 (1.8, 4.0) | 2.4 (1.7, 3.1) |
| HDL cholesterol—mmol/L | 1.1 (1.0, 1.3) | 1.2 (1.0, 1.3) | 1.1 (0.9, 1.4) |
| Triglycerides—mmol/L | 1.8 (1.2, 2.6) | 1.7 (1.3, 2.6) | 1.8 (1.3, 2.4) |
| C-reactive protein—mg/L | 3.6 (1.6, 4.9) | 3.2 (2.1, 4.5) | 3.4 (1.6, 6.6) |
| Interleukin-6—mg/L | 2.2 (2.0, 3.9) | 2.6 (2.0, 3.9) | 3.7 (1.6, 6.8) |
Data are presented as median (IQR) or n (%). HDL, high-density lipoprotein; LDL, low-density lipoprotein. Concentrations of Interleukin-6 in the two studies were measured with different assays.