Table 3.
Summary of Secondary Efficacy Outcome Measures, FAS
| Measures/Scores | LS Mean Change from Baseline (SE)a | Treatment Difference vs Placeboa | ||||
|---|---|---|---|---|---|---|
| n | Pregabalin | n | Placebo | LS Mean Difference (95% CI) | P value | |
| FIQ total | 170 | −11.14 (1.34) | 164 | −8.15 (1.37) | −2.99 (−6.30 to 0.32) | 0.0762 |
| MOS-SS sleep disturbance | 169 | −11.45 (1.61) | 164 | −8.02 (1.64) | −3.43 (−7.39 to 0.54) | 0.0900 |
| Sleep interference | 170 | −1.88 (0.15) | 164 | −1.0 (0.15) | −0.88 (−1.26 to −0.50) | <0.0001 |
| SSQ | ||||||
| sWASO (min) | 168 | −42.36 (5.92) | 161 | −25.19 (6.01) | −17.17 (−32.4 to −1.92) | 0.0273 |
| sLSO (min) | 170 | −0.26 (0.05) | 163 | −0.28 (0.05) | 0.02 (−0.12 to 0.15) | 0.8082 |
| sNAASO (min) | 170 | −0.95 (0.09) | 163 | −0.30 (0.10) | −0.66 (−0.89 to −0.41) | <0.0001 |
| sTST (min) | 169 | 24.63 (5.85) | 164 | 17.23 (5.96) | 7.40 (−7.76 to 22.6) | 0.3388 |
| Sleep quality | 169 | 1.59 (0.17) | 164 | 0.82 (0.17) | 0.77 (0.35 to 1.18) | 0.0003 |
| MAF index | 166 | −4.09 (0.68) | 161 | −3.25 (0.68) | −0.84 (−2.50 to 0.82) | 0.3186 |
| SF-36 | ||||||
| Mental component | 170 | 2.68 (0.83) | 164 | 2.30 (0.85) | 0.38 (−1.67 to 2.43) | 0.7149 |
| Physical component | 170 | 4.44 (0.54) | 164 | 3.66 (0.55) | 0.79 (−0.54 to 2.11) | 0.2442 |
| Pain VAS | 170 | −17.04 (1.92) | 164 | −13.43 (1.95) | −3.62 (−8.34 to 1.1) | 0.1332 |
| HADS | ||||||
| Anxiety | 170 | −1.03 (0.29) | 164 | −0.65 (0.29) | −0.38 (−1.09 to 0.33) | 0.2934 |
| Depression | 170 | −1.11 (0.29) | 164 | −0.28 (0.29) | −0.83 (−1.54 to −0.12) | 0.0226 |
Note: aSummary for all subjects with baseline data.
Abbreviations: CI, confidence interval; FAS, full analysis set; FIQ, Fibromyalgia Impact Questionnaire; HADS, Hospital Anxiety and Depression Scale; LS, least-squares; MAF, Multidimensional Assessment of Fatigue; MOS-SS, Medical Outcomes Study Sleep Scale; SE, standard error; SF-36, 36-Item Short Form Health Survey; sLSO, latency to sleep onset; sNAASO, subjective number of awakenings after sleep onset; SSQ, Subjective Sleep Questionnaire; sTST, subjective total sleep time; sWASO, subjective wake after sleep onset; VAS, visual analog scale.