38901
document
A dose-ranging study of pramipexole for the symptomatic treatment of restless legs syndrome : polysomnographic evaluation of periodic leg movements and sleep disturbance . OBJECTIVE To evaluate , both polysomnographically and by subjective scales , the efficacy and safety profile of pramipexole for restless legs syndrome ( RLS ) via a 3-week , double-blind , placebo-controlled , parallel-group , dose-ranging study . METHODS At baseline and after 3 weeks , periodic limb movements ( PLM ) and sleep parameters were assessed by polysomnography , and patients self-assessed their sleep disturbance and overall RLS severity using the international RLS study group rating scale ( IRLS ) . Four pramipexole doses were evaluated : 0.125 , 0.25 , 0.50 , and 0.75mg/d . Data from 107 patients were included in the intent-to-treat ( ITT ) analysis . RESULTS For pramipexole recipients , the primary outcome measure , PLM per hour in bed asleep or awake ( the PLM index , or PLMI ) , decreased by a median of -26.55 to -52.70 depending on dosage group , vs. -3.00 for placebo ( p < 0.01 or 0.001 for each group vs. placebo ; Wilcoxon-Mann-Whitney test ) . Improvements in the secondary endpoints of PLM while asleep and while awake were also significantly superior for pramipexole . At 3 weeks , all pramipexole doses reduced the median for PLM while asleep to levels considered normal ( < 5PLM/h ) . Except for delta-sleep time and awakenings/arousals , sleep parameters remained unchanged or favored pramipexole . Median sleep latency was reduced by -5.00 to -11.75min in the pramipexole groups , vs. -2.00 for placebo ( p < 0.05 for all groups except 0.25mg/d ) . Median total sleep time increased by 25.75-66.75min , vs. 25.50 ( p < 0.05 for 0.50mg/d ) , and median time in stages 2-4/rapid eye movement ( REM ) sleep increased by 37.00-68.00min , vs. 26.75 ( p < 0.05 for 0.50mg/d ) . By subjective IRLS ratings , all pramipexole doses were significantly superior to placebo . Safety analysis demonstrated no dose-dependent increase in adverse events , and no drug-related increase in daytime somnolence was observed . CONCLUSIONS Pramipexole is effective and well tolerated in RLS , most notably among objective measures , for reducing PLM and decreasing sleep latency . Although other sleep parameters showed lesser , usually insignificant change , patients ' subjective ratings of RLS severity and sleep disturbance were significantly improved ( p0.0023 ) .
38902
Intervention_Pharmacological
pramipexole
38903
Intervention_Pharmacological
pramipexole
38904
Intervention_Pharmacological
pramipexole
38905
Intervention_Pharmacological
pramipexole
38906
Intervention_Control
placebo
38907
Intervention_Pharmacological
pramipexole
38908
Intervention_Pharmacological
pramipexole .
38909
Intervention_Control
placebo
38910
Intervention_Pharmacological
pramipexole
38911
Intervention_Control
placebo .
38912
Intervention_Pharmacological
Pramipexole
38913
Outcome_Physical
periodic leg movements
38914
Outcome_Other
efficacy
38915
Outcome_Other
safety
38916
Outcome_Physical
periodic limb movements ( PLM )
38917
Outcome_Physical
sleep parameters
38918
Outcome_Physical
sleep disturbance
38919
Outcome_Physical
RLS severity
38920
Outcome_Physical
PLM per hour in bed asleep or awake
38921
Outcome_Physical
endpoints of PLM while asleep and while awake
38922
Outcome_Physical
median for PLM while asleep
38923
Outcome_Physical
delta-sleep time and awakenings/arousals
38924
Outcome_Physical
Median sleep latency
38925
Outcome_Physical
Median total sleep time
38926
Outcome_Physical
2-4/rapid eye movement ( REM ) sleep
38927
Outcome_Adverse-effects
adverse events
38928
Outcome_Adverse-effects
daytime somnolence
38929
Outcome_Other
effective
38930
Outcome_Other
well tolerated
38931
Outcome_Physical
reducing PLM
38932
Outcome_Physical
decreasing sleep latency
38933
Outcome_Physical
RLS severity
38934
Outcome_Physical
sleep disturbance
38935
Participant_Age
restless legs syndrome :
38936
Participant_Condition
restless legs syndrome ( RLS )
38937
Participant_Age
107 patients