Rotigotine improves restless legs syndrome: a 6-month randomized, double-blind, placebo-controlled trial in the United States.
Identifieur interne : 002C55 ( Ncbi/Checkpoint ); précédent : 002C54; suivant : 002C56Rotigotine improves restless legs syndrome: a 6-month randomized, double-blind, placebo-controlled trial in the United States.
Auteurs : Wayne A. Hening [États-Unis] ; Richard P. Allen ; William G. Ondo ; Arthur S. Walters ; John W. Winkelman ; Philip Becker ; Richard Bogan ; June M. Fry ; David B. Kudrow ; Kurt W. Lesh ; Andreas Fichtner ; Erwin SchollmayerSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2010.
Descripteurs français
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Dopamine Agonists (therapeutic use), Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Restless Legs Syndrome (drug therapy), Severity of Illness Index, Tetrahydronaphthalenes (therapeutic use), Thiophenes (therapeutic use), Transdermal Patch, Treatment Outcome, United States (epidemiology), Young Adult.
- MESH :
- chemical , therapeutic use : Dopamine Agonists, Tetrahydronaphthalenes, Thiophenes.
- geographic , epidemiology : United States.
- drug therapy : Restless Legs Syndrome.
- Adolescent, Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Severity of Illness Index, Transdermal Patch, Treatment Outcome, Young Adult.
Abstract
This randomized, double-blinded, placebo-controlled trial (NCT00135993) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome (RLS) over a 6-month maintenance period. A total of 505 eligible participants with moderate to severe RLS (IRLS sum score >or= 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once-daily transdermal patch (fixed-dose regimen). The two co-primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI-1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo (P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were -4.5 (95% CI: -6.9, -2.2) for 2 mg/24 hr rotigotine, -5.2 (95% CI: -7.5, -2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 -0.65 (95% CI: -1.0, -0.3) and -0.9 (95% CI: -1.3, -0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6-month double-blind period.
DOI: 10.1002/mds.23157
PubMed: 20629075
Affiliations:
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Allen</name></author><author><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G" last="Ondo">William G. Ondo</name></author><author><name sortKey="Walters, Arthur S" sort="Walters, Arthur S" uniqKey="Walters A" first="Arthur S" last="Walters">Arthur S. Walters</name></author><author><name sortKey="Winkelman, John W" sort="Winkelman, John W" uniqKey="Winkelman J" first="John W" last="Winkelman">John W. Winkelman</name></author><author><name sortKey="Becker, Philip" sort="Becker, Philip" uniqKey="Becker P" first="Philip" last="Becker">Philip Becker</name></author><author><name sortKey="Bogan, Richard" sort="Bogan, Richard" uniqKey="Bogan R" first="Richard" last="Bogan">Richard Bogan</name></author><author><name sortKey="Fry, June M" sort="Fry, June M" uniqKey="Fry J" first="June M" last="Fry">June M. Fry</name></author><author><name sortKey="Kudrow, David B" sort="Kudrow, David B" uniqKey="Kudrow D" first="David B" last="Kudrow">David B. 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Walters</name></author><author><name sortKey="Winkelman, John W" sort="Winkelman, John W" uniqKey="Winkelman J" first="John W" last="Winkelman">John W. Winkelman</name></author><author><name sortKey="Becker, Philip" sort="Becker, Philip" uniqKey="Becker P" first="Philip" last="Becker">Philip Becker</name></author><author><name sortKey="Bogan, Richard" sort="Bogan, Richard" uniqKey="Bogan R" first="Richard" last="Bogan">Richard Bogan</name></author><author><name sortKey="Fry, June M" sort="Fry, June M" uniqKey="Fry J" first="June M" last="Fry">June M. Fry</name></author><author><name sortKey="Kudrow, David B" sort="Kudrow, David B" uniqKey="Kudrow D" first="David B" last="Kudrow">David B. Kudrow</name></author><author><name sortKey="Lesh, Kurt W" sort="Lesh, Kurt W" uniqKey="Lesh K" first="Kurt W" last="Lesh">Kurt W. 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A total of 505 eligible participants with moderate to severe RLS (IRLS sum score >or= 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once-daily transdermal patch (fixed-dose regimen). The two co-primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI-1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo (P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were -4.5 (95% CI: -6.9, -2.2) for 2 mg/24 hr rotigotine, -5.2 (95% CI: -7.5, -2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 -0.65 (95% CI: -1.0, -0.3) and -0.9 (95% CI: -1.3, -0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6-month double-blind period.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>New Jersey</li></region></list><tree><noCountry><name sortKey="Allen, Richard P" sort="Allen, Richard P" uniqKey="Allen R" first="Richard P" last="Allen">Richard P. Allen</name><name sortKey="Becker, Philip" sort="Becker, Philip" uniqKey="Becker P" first="Philip" last="Becker">Philip Becker</name><name sortKey="Bogan, Richard" sort="Bogan, Richard" uniqKey="Bogan R" first="Richard" last="Bogan">Richard Bogan</name><name sortKey="Fichtner, Andreas" sort="Fichtner, Andreas" uniqKey="Fichtner A" first="Andreas" last="Fichtner">Andreas Fichtner</name><name sortKey="Fry, June M" sort="Fry, June M" uniqKey="Fry J" first="June M" last="Fry">June M. Fry</name><name sortKey="Kudrow, David B" sort="Kudrow, David B" uniqKey="Kudrow D" first="David B" last="Kudrow">David B. Kudrow</name><name sortKey="Lesh, Kurt W" sort="Lesh, Kurt W" uniqKey="Lesh K" first="Kurt W" last="Lesh">Kurt W. Lesh</name><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G" last="Ondo">William G. Ondo</name><name sortKey="Schollmayer, Erwin" sort="Schollmayer, Erwin" uniqKey="Schollmayer E" first="Erwin" last="Schollmayer">Erwin Schollmayer</name><name sortKey="Walters, Arthur S" sort="Walters, Arthur S" uniqKey="Walters A" first="Arthur S" last="Walters">Arthur S. Walters</name><name sortKey="Winkelman, John W" sort="Winkelman, John W" uniqKey="Winkelman J" first="John W" last="Winkelman">John W. Winkelman</name></noCountry><country name="États-Unis"><region name="New Jersey"><name sortKey="Hening, Wayne A" sort="Hening, Wayne A" uniqKey="Hening W" first="Wayne A" last="Hening">Wayne A. 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