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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 (Hoboken). 2012 Apr; 64(4):597-606.AC

Abstract

OBJECTIVE

To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient-rated sleep, tiredness, and pain in fibromyalgia patients.

METHODS

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.

RESULTS

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%).

CONCLUSION

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.

Authors+Show Affiliations

Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan, USA. troth1@hfhs.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22232085

Citation

Roth, Thomas, et al. "Effect of Pregabalin On Sleep in Patients With Fibromyalgia and Sleep Maintenance Disturbance: a Randomized, Placebo-controlled, 2-way Crossover Polysomnography Study." Arthritis Care & Research, vol. 64, no. 4, 2012, pp. 597-606.
Roth T, Lankford DA, Bhadra P, et al. 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 (Hoboken). 2012;64(4):597-606.
Roth, T., Lankford, D. A., Bhadra, P., Whalen, E., & 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 & Research, 64(4), 597-606. https://doi.org/10.1002/acr.21595
Roth T, et al. 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 (Hoboken). 2012;64(4):597-606. PubMed PMID: 22232085.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study. AU - Roth,Thomas, AU - Lankford,D Alan, AU - Bhadra,Pritha, AU - Whalen,Ed, AU - Resnick,E Malca, PY - 2012/1/11/entrez PY - 2012/1/11/pubmed PY - 2012/7/3/medline SP - 597 EP - 606 JF - Arthritis care & research JO - Arthritis Care Res (Hoboken) VL - 64 IS - 4 N2 - OBJECTIVE: To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient-rated sleep, tiredness, and pain in fibromyalgia patients. METHODS: 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. RESULTS: 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%). CONCLUSION: 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. SN - 2151-4658 UR - https://www.unboundmedicine.com/medline/citation/22232085/Effect_of_pregabalin_on_sleep_in_patients_with_fibromyalgia_and_sleep_maintenance_disturbance:_a_randomized_placebo_controlled_2_way_crossover_polysomnography_study_ L2 - https://doi.org/10.1002/acr.21595 DB - PRIME DP - Unbound Medicine ER -