Pregabalin versus pramipexole: effects on sleep disturbance in restless legs
syndrome.
Author(s): Garcia-Borreguero D(1), Patrick J(2), DuBrava S(2), Becker PM(3), Lankford A(4),
Chen C(2), Miceli J(2), Knapp L(2), Allen RP(5).
Affiliation(s): Author information:
(1)Sleep Research Institute, Madrid, Spain. (2)Pfizer Global Research and
Development, Groton, CT. (3)University of Texas Southwestern Medical Center,
Dallas, TX. (4)Sleep Disorders Center of Georgia, Atlanta, GA. (5)Johns Hopkins
University, Department of Neurology, Baltimore, MD.
Publication date & source: 2014, Sleep. , 37(4):635-43
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.
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