Table 3.
Change in mean pain and sleep scores from baseline to endpoint (LOCF analysis)
| Pregabalin | Placebo | Difference from placebo | ||||
|---|---|---|---|---|---|---|
| n | LS mean change (SE) | n | LS mean change (SE) | LS mean difference (SE) | P-value | |
| Change in pain scorea | ||||||
| NePb | ||||||
| Moderate | 333 | −1.74 (0.17) | 180 | −0.74 (0.19) | −1.00 (0.26) | <0.001 |
| Severe | 150 | −1.77 (0.20) | 79 | −1.05 (0.23) | −0.72 (0.31) | 0.018 |
| Change in sleep scorec | ||||||
| NePb | ||||||
| Moderate | 333 | −1.47 (0.15) | 180 | −0.44 (0.17) | −1.03 (0.22) | <0.001 |
| Severe | 150 | −1.32 (0.18) | 79 | −0.19 (0.20) | −1.13 (0.27) | <0.001 |
Notes: ANOVA model includes baseline pain severity, treatment, and indication (study). Sleep model also included baseline sleep score. Second interaction term included treatment, indication, and baseline pain severity. Subjects with baseline pain <4 and missing baseline pain scores are excluded.
Pain scores range from 0=no pain to 10=worst possible pain; scores of ≥4–<7 were classified as moderate and ≥7–≤10 were classified as severe.
Includes pregabalin 150, 300, 600 mg/day, and flexible 150–600 mg/day treatment groups.
Sleep scores range from 0=pain does not interfere with sleep to 10=pain completely interferes with sleep.
Abbreviations: LOCF, last observation carried forward; LS, least squares; NeP, neuropathic pain.