Introduction
Methods
Study patients
Study design and procedures
Outcome measures
Statistical analyses
Results
Demographic and baseline characteristics
Demographic characteristics | Pregabalin (n = 275) | Placebo (n = 267) | Total (N = 542) |
---|---|---|---|
Age (years) | |||
Mean (SD) | 52.8 (12.9) | 53.5 (12.6) | 53.1 (12.8) |
Range | 20–81 | 20–85 | 20–85 |
Age, years, no. (%) of patients | |||
18–44 | 60 (21.8) | 61 (22.8) | 121 (22.3) |
45–64 | 163 (59.3) | 156 (58.4) | 319 (58.9) |
≥ 65 | 52 (18.9) | 50 (18.7) | 102 (18.8) |
Race, no. (%) of patients | |||
White | 217 (78.9) | 215 (80.5) | 432 (79.7) |
Black | 47 (17.1) | 46 (17.2) | 93 (17.2) |
Asian | 7 (2.5) | 3 (1.1) | 10 (1.8) |
Other | 4 (1.5) | 3 (1.1) | 7 (1.3) |
Weight (kg) | |||
Mean (SD) | 85.9 (20.0) | 86.2 (19.0) | 86.1 (19.5) |
Range | 49.1–193.7 | 45.4–166.0 | 45.4–193.7 |
Height (cm) | |||
Mean (SD) | 170.1 (10.1) | 168.6 (9.4) | 169.4 (9.8) |
Range | 142.2–198·0 | 140.0–198.1 | 140.0–198.1 |
Trauma type, no. (%) of patients | |||
Surgical | 131 (47.6) | 138 (51.7) | 269 (49.6) |
Non-surgical | 144 (52.4) | 129 (48.3) | 273 (50.4) |
Baseline mean pain (daily NRS) | |||
Mean (SD) | 6.41 (1.3) | 6.5 (1.3) | |
Questionnaire: PainDETECT [13] |
N = 274 |
N = 265 | |
Mean (SD) | 23.1 (5.52) | 22.6 (5.52) | |
Range | 2–36 | 3–38 |
Efficacy
Primary analysis
Outcome measure | Screening/baseline (s.d.) | LS mean change from baseline (s.e.) [95% CI] | LS mean difference (s.e.) [95% CI] |
p value | ||
---|---|---|---|---|---|---|
Pregabalin (N = 274) | Placebo (N = 265) | Pregabalin | Placebo | |||
Primary efficacy endpoint, week 15 mean pain | 6.41 (1.29) | 6.54 (1.31) | − 2.12 (0.15) [− 2.42, − 1.82] | − 1.90 (0.16) [– 2.21, − 1.60] | – 0.22 (0.16) [– 0.54, 0.10] | 0.1823 |
Week 1–15 overall mean pain effecta | 6.41 (1.29) | 6.54 (1.31) | – 2.10 (0.10) [– 2.29, − 1.90] | − 1.79 (0.10) [–1.99, − 1.60] | − 0.31 (0.12) [– 0.55, − 0.07] | 0.0117 |
Sleep interference, week 15 | 4.97 (2.30) | 4.99 (2.27) | − 2.29 (0.11) [− 2.51, − 2.07] | − 1.86 (0.11) [− 2.08, − 1.63] | − 0.43 (0.15) [− 0.71, − 0.14] | 0.0031 |
Endpoint BPI pain severity | 5.95 (1.50) | 5.90 (1.50) | − 2.40 (0.13) [− 2.66, − 2.15] | − 1.95 (0.13) [− 2.21, − 1.69] | − 0.46 (0.16) [− 0.77, − 0.14] | 0.0050 |
Endpoint BPI pain interference | 4.07 (2.16) | 4.06 (2.11) | − 1.72 (0.13) − 1.97, − 1.46] | − 1.33 (0.13) [− 1.59, − 1.07] | − 0.38 (0.16) [− 0.70, − 0.07] | 0.0168 |
Safety
No. (%) of patients with adverse events (treatment related) by preferred term | Pregabalin (N = 274) No. (%) | Placebo (N = 265) No. (%) |
---|---|---|
Dizziness | 40 (14.6) | 11 (4.2) |
Somnolence | 27 (9.9) | 9 (3.4) |
Fatigue | 14 (5.1) | 10 (3.8) |
Nausea | 14 (5.1) | 8 (3.0) |
Headache | 12 (4.4) | 8 (3.0) |
Vertigo Back pain Disturbance in attention | 12 (4.4) 8 (2.9) 8 (2.9) | 1 (0.4) 5 (1.9) 0 |
Memory impairment Nasopharyngitis Constipation | 7 (2.6) 7 (2.6) 6 (2.2) | 0 8 (3.0) 4 (1.5) |
Sedation Pain in extremity Insomnia | 6 (2.2) 2 (0.7) 2 (0.7) | 0 6 (2.3) 6 (2.3) |