Dr. Roth has received research funding from Aventis, Cephalon, GlaxoSmithKline, Merck, Neurocrine, Pfizer, Sanofi-Aventis, Schering-Plough, Sepracor, Somaxon, Somnus, Syrex, Takeda, TransOral, Ventus, Wyeth, and XenoPort; has acted as a consultant or serves on an advisory board for Abbott, Acadia, Acologix, Acorda, Actelion, Addrenex, Alchemers, Alza, Ancel, Arena, AstraZeneca, Aventis, Aver, Bayer, BMS, BTG, Cephalon, Cypress, Dove, Eisai, Elan, Eli Lilly, Evotec, Forest, GlaxoSmithKline, Hypnion, Impax, Intec, Intra-Cellular, Jazz, Johnson & Johnson, King, Lundbeck, McNeil, MediciNova, Merck, Neurim, Neurocrine, Neurogen, Novartis, Ocera, Orexo, Organon, Otsuka, Prestwick, Procter & Gamble, Pfizer, Purdue, Resteva, Roche, Sanofi-Aventis, Sepracor, Servier, Shire, Somaxon, Somnus, Steady Sleep Rx, Syrex, Takeda, Transcept, TransOral, Vanda, Ventus, VivoMetrics, Wyeth, XenoPort, and Yamanouchi; and has received speaking fees from Cephalon, Sanofi-Aventis, and Sepracor.
Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: A randomized, placebo-controlled, 2-way crossover polysomnography study†
Version of Record online: 27 MAR 2012
Copyright © 2012 by the American College of Rheumatology
Arthritis Care & Research
Volume 64, Issue 4, pages 597–606, April 2012
How to Cite
Roth, T., Lankford, D. A., Bhadra, P., Whalen, E. and Resnick, E. M. (2012), Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: A randomized, placebo-controlled, 2-way crossover polysomnography study. Arthritis Care Res, 64: 597–606. doi: 10.1002/acr.21595
ClinicalTrials.gov identifier: NCT00883740.
- Issue online: 27 MAR 2012
- Version of Record online: 27 MAR 2012
- Accepted manuscript online: 9 JAN 2012 11:01AM EST
- Manuscript Accepted: 23 DEC 2011
- Manuscript Received: 27 JUL 2011
- Pfizer Inc.
To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient-rated sleep, tiredness, and pain in fibromyalgia patients.
We performed a randomized, double-blind, placebo-controlled, 2-period crossover PSG study. Patients ages ≥18 years with fibromyalgia satisfied subjective and objective sleep disturbance criteria prior to randomization. Eligible patients were randomized (1:1) to pregabalin (300–450 mg/day) or placebo for crossover period 1, and vice versa for period 2. Each crossover period comprised a dose-adjustment and dose-maintenance phase, with a 2-week taper/washout between periods. In-laboratory PSGs were recorded during 2 consecutive nights at screening and at the end of each crossover period. The primary end point was the difference in sleep maintenance defined by PSG-recorded wake after sleep onset (WASO; minutes) between 4 weeks of treatment with pregabalin and with placebo. Other PSG measures; patient-rated sleep, tiredness, and pain; and tolerability were assessed.
Of 119 patients randomized (103 women [86.6%], mean age 48.4 years), 102 (85.7%) completed both periods. Patients treated with pregabalin showed a reduction in PSG-determined WASO versus treatment with placebo (week 4 difference: −19.2 minutes [95% confidence interval (95% CI) −26.7, −11.6]; P < 0.0001). Pain score improved (decreased) with pregabalin versus placebo treatment at all 4 weeks (week 4 difference: −0.52 [95% CI −0.90, −0.14]; P = 0.0084). Modest (ρ = <0.3) but significant correlations were found between PSG sleep assessments and ratings of pain and sleep quality. Frequently reported all-causality adverse events (pregabalin versus placebo) were: dizziness (30.4% versus 9.9%), somnolence (20.5% versus 4.5%), and headache (8.9% versus 8.1%).
Patients with fibromyalgia treated with pregabalin had statistically significant and meaningful improvements in sleep, as assessed by PSG. Patients with fibromyalgia also reported decreased daily pain. Pregabalin was well tolerated.