Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: A randomized, placebo-controlled, 2-way crossover polysomnography study
- Source: Arthritis Care & Research, April 2012
By Thomas Roth, PhD, et al.
[Ed Note: Wake after sleep onset (WASO) was measured. This “quantifies the night time minutes spent awake after falling into a persistent sleep state, and is considered one of the key sleep parameters for characterizing the effect of a hypnotic [sleep-inducing] drug.” In this study the average reduction in minutes of wake after sleep onset for FM patients taking a daily pregabalin dose of 300mg to 450mg was 19.2 minutes. Additionally, average total sleep time was 25.5 minutes greater for the pregabalen group – 6.6 hours vs 6.2 for placebo group. See a MedPage Today physician CME summary for details on other measures not mentioned in the abstract (http://www.medpagetoday.com/clinical-context/Fibromyalgia/31924.
Lead investigator Thomas Roth, PhD, directs the Henry Ford Health System Sleep Disorders and Research Center, Detroit.]
Objective: 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 or older 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 (p = <0.3) but significant correlations were found between PSG sleep assessments and ratings of pain and sleep quality. [Note: the p score of <0.3 would indicate the chances of this result occurring by chance would be less than 3 in 10.]
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.
ClinicalTrials.gov identifier: NCT00883740.
Source: Arthritis Care & Research, April 2012;64:597-606. PMID: 22232085, by Roth T, Lankford DA, Bhadra P, Whalen E, Resnick EM. Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan; Sleep Disorders Center of Georgia, Atlana; Pfizer Inc., New York, NY, USA. [Email: firstname.lastname@example.org] Research funded by Pfizer Inc. For details on investigators’ research funding and stock ownership/options, see http://onlinelibrary.wiley.com/doi/10.1002/acr.21595/full