Pregabalin versus pramipexole: effects on sleep disturbance in restless legs syndrome.
نویسندگان
چکیده
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.
منابع مشابه
Upper Airway Stimulation for Obstructive Sleep Apnoea 2 Comparison of Pregabalin with Pramipexole for Restless Legs Syndrome 2 Obstructive Sleep Apnoea in Patients With Typical Atrial Flutter- Prevalence and Impact on Arrhythmia
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Practice guideline summary: Treatment of restless legs syndrome in adults: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.
OBJECTIVE To make evidence-based recommendations regarding restless legs syndrome (RLS) management in adults. METHODS Articles were classified per the 2004 American Academy of Neurology evidence rating scheme. Recommendations were tied to evidence strength. RESULTS AND RECOMMENDATIONS In moderate to severe primary RLS, clinicians should consider prescribing medication to reduce RLS symptoms...
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عنوان ژورنال:
- Sleep
دوره 37 4 شماره
صفحات -
تاریخ انتشار 2014