18348
document
Ropinirole as a treatment of restless legs syndrome in patients on chronic hemodialysis : an open randomized crossover trial versus levodopa sustained release . OBJECTIVE Restless legs syndrome ( RLS ) is a common neurologic condition characterized by uncomfortable and unpleasant sensations in the legs , occurring primarily at rest , which are usually worse in the evening and are alleviated by movement . RLS is present in 20-40 % of patients with renal failure . This study was a 14-week open , randomized , crossover trial of ropinirole vs. levodopa sustained release ( SR ) in 11 patients with RLS on chronic hemodialysis . METHODS Eleven patients ( 7 men , 4 women ) were enrolled in the study . They received either levodopa SR or ropinirole for 6 weeks , followed by a washout week , then the alternate treatment for 6 weeks . Patients rated the severity of RLS by means of a 6-item questionnaire developed by the International Restless Legs Study Group ( 6-item IRLS ) , by the Clinical Global Impression ( CGI ) scale , and by sleep diaries . RESULTS Under treatment with levodopa SR , 1 patient presented severe vomiting , leading to study discontinuation . The 10 patients who completed the study reported a 33.5 % improvement ( from 16.7 +/- 3.2 to 11.1 +/- 4 ; P < 0.001 ) of the 6-item IRLS scores during levodopa SR treatment and a 73.5 % improvement ( from 16.6 +/- 2.8 to 4.4 +/- 3.8 ; P < 0.001 ) during ropinirole treatment . By the end of the study the mean levodopa SR dosage was 190 mg/d and the mean ropinirole dosage was 1.45 mg/d . Ropinirole was superior to levodopa SR in reducing 6-item IRLS scores ( P < 0.001 ) and in increasing sleep time ( P < 0.001 ) . The patient CGI scale showed a significant difference favoring ropinirole ( P < 0.01 ) . There was no significant carryover or period effect for any outcome measure . Four patients reported a complete reversion of RLS symptoms during ropinirole treatment at doses ranging from 0.25-2 mg/d . CONCLUSIONS These results suggest that ropinirole is more effective than levodopa SR in the treatment of RLS in patients on chronic hemodialysis .
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Intervention_Pharmacological
Ropinirole
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Intervention_Pharmacological
levodopa sustained release
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Intervention_Pharmacological
ropinirole
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Intervention_Pharmacological
levodopa sustained release ( SR )
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Intervention_Pharmacological
levodopa SR
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Intervention_Pharmacological
ropinirole
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Intervention_Pharmacological
alternate treatment
18356
Intervention_Pharmacological
Ropinirole
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Intervention_Pharmacological
levodopa SR
18358
Outcome_Physical
severity of RLS
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Outcome_Adverse-effects
severe vomiting
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Outcome_Physical
sleep time
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Outcome_Physical
CGI scale
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Outcome_Physical
RLS symptoms
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Participant_Condition
restless legs syndrome in patients on chronic hemodialysis :
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Participant_Condition
renal failure
18365
Participant_Sample-size
11
18366
Participant_Sample-size
7
18367
Participant_Sex
men
18368
Participant_Sample-size
4
18369
Participant_Sex
women
18370
Participant_Sample-size
10
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Participant_Condition
who completed the study