A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia

Table 4 MOS-Sleep Scale scores at baseline and final assessment

Assessment	Baseline mean score ± SD		Final assessment LS mean score ± SE		Placebo-adjusted LS mean change from baseline with pregabalin^a
	Placebo	Pregabalin	Placebo	Pregabalin	Change	95% CI	P-value
Sleep disturbance^b	47.7 ± 26.1	48.0 ± 26.5	39.76 ± 1.31	30.27 ± 1.31	-9.48	-13.12, -5.85	<0.0001*
Sleep adequacy	29.0 ± 23.7	28.7 ± 24.5	36.91 ± 1.41	44.39 ± 1.40	7.48	3.58, 11.38	<0.0001*
Quantity of sleep	5.4 ± 1.4	5.6 ± 1.3	5.70 ± 0.06	5.99 ± 0.06	0.29	0.11, 0.47	0.0007*
Awakening short of breath/headache	25.8 ± 26.6	26.2 ± 26.1	22.99 ± 1.36	18.00 ± 1.36	-4.99	-8.77, -1.21	0.0049*
Snoring	26.5 ± 28.7	25.0 ± 28.1	24.19 ± 1.33	29.17 ± 1.33	4.98	1.29, 8.68	0.9958
Somnolence	41.6 ± 23.3	40.5 ± 24.3	36.41 ± 1.29	47.71 ± 1.28	11.31	7.74, 14.87	1.0000
Overall sleep problems index	49.8 ± 17.2	49.7 ± 18.5	42.66 ± 0.96	39.67 ± 0.95	-2.99	-5.65, -0.33	0.0137*

^aDifference in mean change from baseline, compared with placebo using the baseline score as covariate. ^bMOS-Sleep Scale subscales scored from 0 to 100 with higher scores indicating more of the attribute named in the subscale except for 'quantity of sleep', scored from 0 to 24 indicating the number of hours of sleep.
*Indicates statistical significance at the P <0.025 level.
CI, confidence interval; LS, least squares; MOS, Medical Outcomes Study; SD, standard deviation; SE, standard error

ISSN: 1478-6362