Demographic and clinical characteristics of randomized patients.
| Characteristic | Placebo | Pregabalin 300 mg/day | Pregabalin 450 mg/day | Pregabalin 600 mg/day | All Patients | European Patients | Non-European Patients |
|---|---|---|---|---|---|---|---|
| No. patients | 184 | 184 | 182 | 186 | 736 | 379 | 357 |
| Age, mean (SD), yrs | 48.1 (11.3) | 48.4 (10.8) | 48.0 (11.3) | 49.6 (11.3) | 48.5 (11.2) | 48.4 (21–77)* | 48.7 (20–81)* |
| 18–64 yrs, n (%) | 172 (93.5) | 175 (95.1) | 167 (91.8) | 166 (89.2) | 680 (92.4) | 349 (92.1) | 331 (92.7) |
| ≥ 65 yrs, n (%) | 12 (6.5) | 9 (4.9) | 15 (8.2) | 20 (10.8) | 56 (7.6) | 30 (7.9) | 26 (7.3) |
| Women, n (%) | 168 (91.3) | 167 (90.8) | 169 (92.9) | 169 (90.9) | 673 (91.4) | 350 (92.3) | 323 (90.5) |
| Postmenopausal, n (%) | 85 (46.2) | 90 (48.9) | 78 (42.9) | 95 (51.1) | 348 (47.3) | 174 (45.9) | 174 (48.7) |
| Race | |||||||
| White, n (%) | 141 (76.6) | 143 (77.7) | 136 (74.7) | 139 (74.7) | 559 (76.0) | 364 (96.0) | 195 (54.6) |
| Black, n (%) | 0 | 1 (0.5) | 0 | 0 | 1 (0.1) | 1 (0.3) | 0 |
| Hispanic, n (%) | 24 (13.0) | 21 (11.4) | 24 (13.2) | 23 (12.4) | 92 (12.5) | 9 (2.4) | 83 (23.2) |
| Other | 19 (10.3) | 19 (10.3) | 22 (12.1) | 24 (12.9) | 84 (11.4) | 5 (1.3) | 79 (22.1) |
| Weight, mean (SD), kg | 72.2 (15) | 70.2 (14.6) | 74.1 (17.6) | 73.5 (16.4) | 72.5 (16.0) | 72.9 (15.7) | 72.0 (16.4) |
| Duration of FM prior to baseline, mean (SD), mo | 107.6 (98.7) | 83.7 (80.6) | 88.6 (82.5) | 115.2 (107.6) | 98.8 (93.8) | 96.6 (91.5) | 101.2 (96.4) |
| No. painful tender points, mean (SD) | 17.0 (1.6) | 17.0 (1.7) | 17.2 (1.7) | 17.2 (1.5) | 17.1 (1.6) | 17.2 (1.5) | 17.0 (1.8) |
| Mean pain score and sleep quality score (range 0–10), mean (SD) | |||||||
| Mean pain score | 6.68 (1.48) | 6.76 (1.29) | 6.57 (1.31) | 6.59 (1.37) | 6.65 (1.36) | 6.55 (1.34) | 6.76 (1.39) |
| Mean sleep quality score | 6.01 (1.90) | 5.94 (1.71) | 5.94 (1.70) | 5.91 (1.80) | 5.95 (1.78) | 5.80 (1.72) | 6.11 (1.82) |
| Fibromyalgia Impact Questionnaire (range 0–100), mean (SD) | |||||||
| Total score | 62.58 (14.85) | 60.69 (14.78) | 60.59 (14.59) | 60.40 (13.87) | 61.08 (14.52) | 60.36 (14.84) | 61.82 (14.16) |
| Medical Outcomes Study-Sleep Scale (range 0–100), mean (SD) | |||||||
| Sleep disturbance | 60.02 (25.60) | 61.80 (25.86) | 59.59 (26.55) | 60.37 (25.09) | 60.47 (25.72) | 61.07 (25.70) | 59.78 (25.79) |
↵* Mean (range). FM: fibromyalgia; BL: baseline.