Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects

Figures & data

Table 1 Patient Demographics and Baseline Characteristics

Measure	Pregabalin	Placebo
	N=170	N=164
Sex, n (%)
Male	28 (16.5)	20 (12.2)
Female	142 (83.5)	144 (87.8)
Age, years
Mean ± SD	44.5 ± 11.5	43.5 ± 10.6
Range	20–78	18–71
Race, n (%)
Asian	170 (100.0)	164 (100.0)
Weight, kg
Mean ± SD	59.3 ± 8.7	58.5 ± 10.0
Range	40–85	36–90
Duration since FM onset, years
Mean ± SD	6.0 ± 7.0	5.6 ± 6.4
Median (range)	3.1 (0.3–30.4)	3.2 (0.3–32.1)
Baseline pain^a
Mean ± SD	6.2 ± 1.4	6.2 ± 1.4
Median	6.2	6.0
Baseline sleep^b
Mean ± SD	5.0 ± 2.2	4.8 ± 2.0
Median	5.4	5.0

Notes: ^aScore based on an 11-point NRS from 0 (“no pain”) to 10 (“worst possible pain”). ^bScore based on an 11-point NRS from 0 (“best possible sleep”) to 10 (“worst possible sleep”).

Abbreviations: FM, fibromyalgia; NRS, numerical rating scale; SD, standard deviation.

Figure 1 Patient disposition^a.

Note: ^aThe per-protocol analysis set (PPAS) was a subset of the full analysis set (FAS) containing only subjects without any major protocol deviations that would affect efficacy assessments (see Table S1).

Table 2 Primary Efficacy Outcome (FAS MMRM) of Change from Baseline in Mean Pain Score at Endpoint Between Patients Treated with Pregabalin vs Placebo, and Associated Sensitivity Analyses

	Primary Analysis		Sensitivity Analyses^a
	FAS (MMRM)		FAS (ANCOVA, LOCF)		PPAS (MMRM)
	Pregabalin	Placebo	Pregabalin	Placebo	Pregabalin	Placebo
N	170	164	162	159	131	130
Baseline mean ± SD	6.23 ± 1.39	6.18 ± 1.38	6.26 ± 1.39	6.14 ± 1.37	6.33 ± 1.35	6.14 ± 1.38
LS mean change at endpoint (SE)	–2.01 (0.15)	–1.28 (0.15)	–1.86 (0.17)	–1.16 (0.18)	–2.08 (0.17)	–1.26 (0.16)
LS mean difference vs placebo (SE)	–0.73 (0.19)		–0.70 (0.21)		–0.820 (0.21)
95% CI	–1.10 to –0.36		–1.12 to –0.28		–1.23 to –0.41
P value	0.0001		0.0011		0.0001

Note: ^aThe per-protocol analysis set (PPAS) was a subset of the full analysis set (FAS) containing only subjects without any major protocol deviations that would affect efficacy assessments (see Supplementary Table S1).

Abbreviations: ANCOVA, analysis of covariance; CI, confidence interval; FAS, full analysis set; LOCF, last observation carried forward; LS, least-squares; MMRM, mixed model repeated measures; PPAS, per-protocol analysis set; SD, standard deviation; SE, standard error.

Figure 2 Change from baseline in weekly mean pain score (FAS, MMRM). *All P<0.05 vs placebo.

Abbreviations: FAS, full analysis set; LS, least-squares; MMRM, mixed model repeated measures; SE, standard error.

Table 3 Summary of Secondary Efficacy Outcome Measures, FAS

Measures/Scores	LS Mean Change from Baseline (SE)^a				Treatment Difference vs Placebo^a
	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.

Table 4 Overview of Common Treatment-Emergent AEs (All-Causality Safety Analysis)

	Pregabalin	Placebo
	N=170	N=164
AEs, n	272	217
Patients with AEs, n (%)	119 (70.0)	103 (62.8)
Patients with serious AEs, n (%)	0	9 (5.5)
Patients with severe AEs, n (%)	16 (9.4)	15 (9.1)
Discontinuations due to AEs, n (%)	22 (12.9)	11 (6.7)
Dose reduced/temporary discontinuation due to AE, n (%)	25 (14.7)	11 (6.7)
Common AEs^a, n (%)
Dizziness	71 (41.8)	30 (18.3)
Somnolence	30 (17.6)	13 (7.9)
Headache	10 (5.9)	10 (6.1)
Upper respiratory tract infection	10 (5.9)	7 (4.3)

Note: ^aIn ≥5% of patients in any treatment group.

Abbreviation: AE, adverse event.