Population/Measure | n | Mean | Mean Change* | Standard Error | Treatment Difference** | p |
All patients | ||||||
Mean pain score | ||||||
Placebo | 184 | 5.92 | −0.73 | 0.14 | ||
Pregabalin 300 mg/day | 184 | 5.59 | −1.06 | 0.14 | −0.33 | 0.1694† |
Pregabalin 450 mg/day | 181 | 5.36 | −1.29 | 0.14 | −0.56 | 0.0132† |
Pregabalin 600 mg/day | 186 | 5.69 | −0.96 | 0.14 | −0.23 | 0.2361† |
FIQ total score | ||||||
Placebo | 184 | 54.14 | −6.94 | 1.30 | ||
Pregabalin 300 mg/day | 184 | 52.97 | −8.11 | 1.29 | −1.17 | 0.5126 |
Pregabalin 450 mg/day | 179 | 48.29 | −12.79 | 1.32 | −5.85 | 0.0012 |
Pregabalin 600 mg/day | 186 | 52.70 | −8.38 | 1.29 | −1.44 | 0.4200 |
Mean sleep quality score | ||||||
Placebo | 184 | 5.01 | −0.94 | 0.15 | ||
Pregabalin 300 mg/day | 183 | 4.50 | −1.45 | 0.15 | −0.51 | 0.0151 |
Pregabalin 450 mg/day | 181 | 4.23 | −1.72 | 0.15 | −0.78 | 0.0002 |
Pregabalin 600 mg/day | 186 | 4.00 | −1.95 | 0.15 | −1.01 | < 0.0001 |
MOS-SS sleep disturbance | ||||||
Placebo | 183 | 54.48 | −5.99 | 1.79 | ||
Pregabalin 300 mg/day | 183 | 47.28 | −13.18 | 1.78 | −7.20 | 0.0038 |
Pregabalin 450 mg/day | 177 | 41.20 | −19.26 | 1.84 | −13.28 | < 0.0001 |
Pregabalin 600 mg/day | 185 | 41.77 | −18.70 | 1.78 | −12.71 | < 0.0001 |
Population/Measure | n | Mean | Mean Change* | Standard Error | Treatment Difference** | 95% CI†† |
European patients | ||||||
Mean pain score | ||||||
Placebo | 98 | 5.94 | −0.71 | 0.19 | ||
Pregabalin 300 mg/day | 94 | 5.70 | −0.95 | 0.20 | −0.24 | −0.78 to 0.30 |
Pregabalin 450 mg/day | 91 | 5.45 | −1.20 | 0.20 | −0.49 | −1.03 to 0.05 |
Pregabalin 600 mg/day | 96 | 5.61 | −1.04 | 0.19 | −0.33 | −0.87 to 0.20 |
FIQ total score | ||||||
Placebo | 98 | 54.08 | −7.00 | 1.73 | ||
Pregabalin 300 mg/day | 94 | 56.79 | −4.29 | 1.77 | 2.71 | −2.15 to 7.57 |
Pregabalin 450 mg/day | 91 | 48.26 | −12.82 | 1.80 | −5.82 | −10.72 to −0.91 |
Pregabalin 600 mg/day | 96 | 53.66 | −7.42 | 1.75 | −0.42 | −5.25 to 4.40 |
Mean sleep quality score | ||||||
Placebo | 98 | 5.00 | −0.95 | 0.20 | ||
Pregabalin 300 mg/day | 93 | 4.42 | −1.53 | 0.21 | −0.58 | −1.16 to −0.00 |
Pregabalin 450 mg/day | 91 | 4.29 | −1.66 | 0.21 | −0.71 | −1.29 to −0.13 |
Pregabalin 600 mg/day | 96 | 3.61 | −2.34 | 0.21 | −1.39 | −1.96 to −0.82 |
MOS-SS sleep disturbance | ||||||
Placebo | 98 | 54.61 | −5.86 | 2.39 | ||
Pregabalin 300 mg/day | 94 | 47.80 | −12.67 | 2.44 | −6.81 | −13.52 to −0.11 |
Pregabalin 450 mg/day | 89 | 40.66 | −19.81 | 2.51 | −13.95 | −20.75 to −7.16 |
Pregabalin 600 mg/day | 96 | 37.64 | −22.83 | 2.41 | −16.97 | −23.64 to −10.30 |
Non-European Patients | ||||||
Mean pain score | ||||||
Placebo | 86 | 5.79 | −0.87 | 0.20 | ||
Pregabalin 300 mg/day | 90 | 5.33 | −1.32 | 0.20 | −0.45 | −1.01 to 0.11 |
Pregabalin 450 mg/day | 90 | 5.09 | −1.56 | 0.20 | −0.69 | −1.25 to −0.13 |
Pregabalin 600 mg/day | 90 | 5.61 | −1.04 | 0.20 | −0.18 | −0.74 to 0.38 |
FIQ total score | ||||||
Placebo | 86 | 53.64 | −7.44 | 1.85 | ||
Pregabalin 300 mg/day | 90 | 48.73 | −12.35 | 1.81 | −4.91 | −9.98 to 0.17 |
Pregabalin 450 mg/day | 88 | 47.53 | −13.55 | 1.83 | −6.11 | −11.22 to −1.01 |
Pregabalin 600 mg/day | 90 | 51.02 | −10.06 | 1.81 | −2.62 | −7.69 to 2.45 |
Mean sleep quality score | ||||||
Placebo | 86 | 4.94 | −1.01 | 0.22 | ||
Pregabalin 300 mg/day | 90 | 4.44 | −1.51 | 0.21 | −0.50 | −1.10 to 0.10 |
Pregabalin 450 mg/day | 90 | 4.08 | −1.87 | 0.21 | −0.86 | −1.46 to −0.26 |
Pregabalin 600 mg/day | 90 | 4.24 | −1.72 | 0.21 | −0.70 | −1.30 to −0.10 |
MOS-SS sleep disturbance | ||||||
Placebo | 85 | 53.94 | −6.53 | 2.57 | ||
Pregabalin 300 mg/day | 89 | 46.20 | −14.27 | 2.51 | −7.74 | −14.78 to −0.70 |
Pregabalin 450 mg/day | 88 | 41.91 | −18.56 | 2.52 | −12.03 | −19.09 to −4.97 |
Pregabalin 600 mg/day | 89 | 45.26 | −15.21 | 2.51 | −8.68 | −15.72 to −1.64 |
↵* Mean change from baseline.
↵** Treatment difference from placebo.
↵† Hochberg’s approach was used to protect the type I error rate at the 0.05 level.
↵†† p values were not calculated for the treatment group comparisons to placebo within region. FIQ: Fibromyalgia Impact Questionnaire; MOS-SS: Medical Outcomes Study-Sleep Scale.