Sleep disturbance is prominent in fibromyalgia (FM). This 14-week, randomized, double-blind, placebo-controlled study, evaluated the effect of pregabalin on pain and sleep-related outcomes in FM.

Patients meeting ACR (FM) diagnostic criteria were randomized to pregabalin 300, 450, or 600mg/d (BID) or placebo for 14 weeks (A0081077). Primary efficacy parameter: LOCF endpoint mean pain score (MPS). At baseline and endpoint, patients completed the Medical Outcomes Sleep (MOS) Sleep Scale. Mean Sleep Quality scores (11-point numeric ratings) were derived from patient daily diaries.

745 randomized patients: 95% female, mean age=50 years, baseline MPS: 6.7. Placebo-corrected differences from baseline to endpoint in MPS were: 300mg/d, -0.71 (p=.0009); 450mg/d, -0.98 (p<.0001); 600mg/d, -1.00 (p<.0001). For MOS Sleep Disturbance, all 3 pregabalin groups demonstrated significant improvements versus placebo (300, 450, and 600 mg/d, -8.91 [p=.0006]; -10.63 [p<.0001]; and -14.93 [p<.0001], respectively). Similar improvements were seen in Sleep Quality (300, 450, and 600mg/d; 0.42, p=0.0030; 0.48, p=.0006; and 0.68, p<.0001 respectively) and MOS Sleep Adequacy (300, 450 and 600mg/d; 5.86, p=.0324; 7.89, p=.0036, and 11.16, p<.0001 respectively). Endpoint Mean Sleep Quality scores across all 3 treatment groups showed significant improvements (300, 450 and 600mg/d; -0.74, p=.0006, -1.12, and -1.35, both p<.0001 respectively). Most common AEs: dizziness (all pregabalin, 35.8% vs placebo, 7.6%); somnolence (18.0% vs 3.8%). Incidence of AEs appeared to be dose-related; most were mild to moderate.

Pregabalin treatment demonstrated significant improvements in pain and patient reported measures of sleep disturbance, adequacy, and quality.

Study funded by Pfizer, Inc.