Dataset Information
Pregabalin versus pramipexole: effects on sleep disturbance in restless legs syndrome.
Ontology highlight
ABSTRACT: Study objectives
To compare pregabalin versus placebo and pramipexole for reducing restless legs syndrome (RLS)-related sleep disturbance.Design
Randomized, double-blinded, crossover trial.Setting
Twenty-three US sleep centers.Participants
Eighty-five individuals with moderate to severe idiopathic RLS and associated sleep disturbance.Interventions
Participants were randomized across 6 treatment sequences comprising three 4-week periods on pregabalin 300 mg/day (n = 75), pramipexole 0.5 mg/day (n = 76), or placebo (n = 73).Measurements and results
Polysomnography was conducted over 2 nights at the end of each period. Primary (wake after sleep onset [WASO], pregabalin vs placebo) and key secondary endpoints were analyzed for statistical significance, with descriptive statistics for other endpoints. Pregabalin improved sleep maintenance, demonstrated by reductions in WASO (-27.1 min vs placebo [P < 0.0001]; -26.9 vs pramipexole) and number of awakenings after sleep onset (-2.7 vs placebo; -7.9 vs pramipexole [P < 0.0001]) by polysomnography, and an increase in subjective total sleep time (30.8 min vs placebo [P < 0.0001]; 26.8 vs pramipexole). Pregabalin also increased slow wave sleep duration (20.9 min vs placebo; 32.1 vs pramipexole [P < 0.0001]). Reduction in periodic limb movement arousal index (PLMAI) with pregabalin was similar to pramipexole and greater than placebo (-3.7 PLMA/h [P < 0.0001]), although reduction in total PLM in sleep was less than for pramipexole.Conclusions
This study demonstrated improvements in objective and subjective measures of sleep maintenance and sleep architecture with pregabalin compared with placebo and pramipexole. Effects of pregabalin on periodic limb movement arousal index were comparable to pramipexole.Trial registration
ClinicalTrials.gov identifier, NCT00991276; http://clinicaltrials.gov/show/NCT00991276.
SUBMITTER: Garcia-Borreguero D
PROVIDER: S-EPMC4044751 | biostudies-literature | 2014 Apr
REPOSITORIES: biostudies-literature
Publications
Pregabalin versus pramipexole: effects on sleep disturbance in restless legs syndrome.
Sleep 20140401 4
<h4>Study objectives</h4>To compare pregabalin versus placebo and pramipexole for reducing restless legs syndrome (RLS)-related sleep disturbance.<h4>Design</h4>Randomized, double-blinded, crossover trial.<h4>Setting</h4>Twenty-three US sleep centers.<h4>Participants</h4>Eighty-five individuals with moderate to severe idiopathic RLS and associated sleep disturbance.<h4>Interventions</h4>Participants were randomized across 6 treatment sequences comprising three 4-week periods on pregabalin 300 mg ...[more]