Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: A randomized, placebo-controlled polysomnographic study
Abstract Objective To assess the efficacy of rotigotine transdermal patch in subjects with moderate to severe idiopathic restless legs syndrome (RLS) and periodic limb movement (PLM) in sleep in a double-blind, randomized, placebo-controlled, multicenter study ( NCT00275236 ). Methods Sixty-seven (4...
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| Veröffentlicht in: | Sleep medicine 2010-10, Vol.11 (9), p.848-856 |
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| creator | Oertel, Wolfgang H Beneš, Heike Garcia-Borreguero, Diego Högl, Birgit Poewe, Werner Montagna, Pasquale Ferini-Strambi, Luigi Sixel-Döring, Friederike Trenkwalder, Claudia Partinen, Markku Saletu, Bernd Polo, Olli Fichtner, Andreas Schollmayer, Erwin Kohnen, Ralf Cassel, Werner Penzel, Thomas Stiasny-Kolster, Karin |
| description | Abstract Objective To assess the efficacy of rotigotine transdermal patch in subjects with moderate to severe idiopathic restless legs syndrome (RLS) and periodic limb movement (PLM) in sleep in a double-blind, randomized, placebo-controlled, multicenter study ( NCT00275236 ). Methods Sixty-seven (46 rotigotine, 21 placebo) subjects applied rotigotine (maximum 3 mg/24 h) or placebo patches once-daily during a 4-week maintenance period; efficacy evaluations used polysomnographic measures and clinician/patient ratings. Results Mean PLM index (PLMI; PLM/h time in bed) decreased more with rotigotine (50.9/h to 8.1/h) than with placebo (37.4/h to 27.1/h; adjusted treatment ratio 4.25 (95% CI [2.48, 7.28], p < 0.0001). PLM during sleep with arousal index (PLMSAI; 8.57/h to 2.47/h under rotigotine, 6.5/h to 4.95/h under placebo; adjusted treatment difference: −3.12 (95% CI [−5.36, −0.88], p = 0.0072) also improved more under rotigotine. At end of maintenance, 39% of rotigotine subjects had PLMI levels |
| doi_str_mv | 10.1016/j.sleep.2010.02.014 |
| format | Article |
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Methods Sixty-seven (46 rotigotine, 21 placebo) subjects applied rotigotine (maximum 3 mg/24 h) or placebo patches once-daily during a 4-week maintenance period; efficacy evaluations used polysomnographic measures and clinician/patient ratings. Results Mean PLM index (PLMI; PLM/h time in bed) decreased more with rotigotine (50.9/h to 8.1/h) than with placebo (37.4/h to 27.1/h; adjusted treatment ratio 4.25 (95% CI [2.48, 7.28], p < 0.0001). PLM during sleep with arousal index (PLMSAI; 8.57/h to 2.47/h under rotigotine, 6.5/h to 4.95/h under placebo; adjusted treatment difference: −3.12 (95% CI [−5.36, −0.88], p = 0.0072) also improved more under rotigotine. At end of maintenance, 39% of rotigotine subjects had PLMI levels <5/h and 26% showed no RLS symptoms (IRLS = 0), whereas no placebo subject met these criteria. Common drug-related adverse events for rotigotine and placebo included nausea (21.7%/4.8%), headache (17.4%/14.3%), application site reactions (17.4%/4.8%), and somnolence (10.9%/9.5%); most were mild to moderate in intensity. Conclusions Rotigotine transdermal patch was efficacious and well tolerated in the short-term treatment of RLS motor symptoms and associated sleep disturbances.</description><identifier>ISSN: 1389-9457</identifier><identifier>EISSN: 1878-5506</identifier><identifier>DOI: 10.1016/j.sleep.2010.02.014</identifier><identifier>PMID: 20813583</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Adolescent ; Adult ; Aged ; Dopamine agonist ; Double-Blind Method ; Female ; Humans ; Idiopathic restless legs syndrome ; Male ; Middle Aged ; Movement - drug effects ; Neurology ; Periodic limb movement ; Polysomnography ; Restless Legs Syndrome - drug therapy ; Rotigotine ; Severity of Illness Index ; Sleep ; Sleep Medicine ; Tetrahydronaphthalenes - administration & dosage ; Tetrahydronaphthalenes - adverse effects ; Tetrahydronaphthalenes - therapeutic use ; Thiophenes - administration & dosage ; Thiophenes - adverse effects ; Thiophenes - therapeutic use ; Transdermal Patch ; Treatment Outcome ; Young Adult</subject><ispartof>Sleep medicine, 2010-10, Vol.11 (9), p.848-856</ispartof><rights>Elsevier B.V.</rights><rights>2010 Elsevier B.V.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c413t-4ad3c63b32270a4d8513f1cbae3a5dec4772703e15e7d721c68dc68de05c765f3</citedby><cites>FETCH-LOGICAL-c413t-4ad3c63b32270a4d8513f1cbae3a5dec4772703e15e7d721c68dc68de05c765f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1389945710002765$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20813583$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Oertel, Wolfgang H</creatorcontrib><creatorcontrib>Beneš, Heike</creatorcontrib><creatorcontrib>Garcia-Borreguero, Diego</creatorcontrib><creatorcontrib>Högl, Birgit</creatorcontrib><creatorcontrib>Poewe, Werner</creatorcontrib><creatorcontrib>Montagna, Pasquale</creatorcontrib><creatorcontrib>Ferini-Strambi, Luigi</creatorcontrib><creatorcontrib>Sixel-Döring, Friederike</creatorcontrib><creatorcontrib>Trenkwalder, Claudia</creatorcontrib><creatorcontrib>Partinen, Markku</creatorcontrib><creatorcontrib>Saletu, Bernd</creatorcontrib><creatorcontrib>Polo, Olli</creatorcontrib><creatorcontrib>Fichtner, Andreas</creatorcontrib><creatorcontrib>Schollmayer, Erwin</creatorcontrib><creatorcontrib>Kohnen, Ralf</creatorcontrib><creatorcontrib>Cassel, Werner</creatorcontrib><creatorcontrib>Penzel, Thomas</creatorcontrib><creatorcontrib>Stiasny-Kolster, Karin</creatorcontrib><title>Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: A randomized, placebo-controlled polysomnographic study</title><title>Sleep medicine</title><addtitle>Sleep Med</addtitle><description>Abstract Objective To assess the efficacy of rotigotine transdermal patch in subjects with moderate to severe idiopathic restless legs syndrome (RLS) and periodic limb movement (PLM) in sleep in a double-blind, randomized, placebo-controlled, multicenter study ( NCT00275236 ). Methods Sixty-seven (46 rotigotine, 21 placebo) subjects applied rotigotine (maximum 3 mg/24 h) or placebo patches once-daily during a 4-week maintenance period; efficacy evaluations used polysomnographic measures and clinician/patient ratings. Results Mean PLM index (PLMI; PLM/h time in bed) decreased more with rotigotine (50.9/h to 8.1/h) than with placebo (37.4/h to 27.1/h; adjusted treatment ratio 4.25 (95% CI [2.48, 7.28], p < 0.0001). PLM during sleep with arousal index (PLMSAI; 8.57/h to 2.47/h under rotigotine, 6.5/h to 4.95/h under placebo; adjusted treatment difference: −3.12 (95% CI [−5.36, −0.88], p = 0.0072) also improved more under rotigotine. At end of maintenance, 39% of rotigotine subjects had PLMI levels <5/h and 26% showed no RLS symptoms (IRLS = 0), whereas no placebo subject met these criteria. Common drug-related adverse events for rotigotine and placebo included nausea (21.7%/4.8%), headache (17.4%/14.3%), application site reactions (17.4%/4.8%), and somnolence (10.9%/9.5%); most were mild to moderate in intensity. Conclusions Rotigotine transdermal patch was efficacious and well tolerated in the short-term treatment of RLS motor symptoms and associated sleep disturbances.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Dopamine agonist</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Idiopathic restless legs syndrome</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Movement - drug effects</subject><subject>Neurology</subject><subject>Periodic limb movement</subject><subject>Polysomnography</subject><subject>Restless Legs Syndrome - drug therapy</subject><subject>Rotigotine</subject><subject>Severity of Illness Index</subject><subject>Sleep</subject><subject>Sleep Medicine</subject><subject>Tetrahydronaphthalenes - administration & dosage</subject><subject>Tetrahydronaphthalenes - adverse effects</subject><subject>Tetrahydronaphthalenes - therapeutic use</subject><subject>Thiophenes - administration & dosage</subject><subject>Thiophenes - adverse effects</subject><subject>Thiophenes - therapeutic use</subject><subject>Transdermal Patch</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1389-9457</issn><issn>1878-5506</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFUk1v1DAQtRCIloVfgIR840IWO47jFIlKVUWhUqVKfJwtrz279eLYwZNUCv-B_1ynW3rgwmFka-a9N5p5Q8hrztac8fb9fo0BYFjXrGRYvWa8eUKOeae6SkrWPi1_0Z1UJ41UR-QF4p4xrnjXPCdHNeu4kJ04Jn--ptHvSkSgYzYRHeTeBDqY0d5QH2mfSsaMpZoowi1koN75VOo33tIMOAZApAF2SHGOLqcePtAzWrRc6v1vcO_oEIyFTapsimNOIYCjQwozpj6mXTbDooTj5OaX5NnWBIRXD--K_Lj49P38S3V1_fny_Oyqsg0XY9UYJ2wrNqKuFTON6yQXW243BoSRDmyjVCkI4BKUUzW3beeWACatauVWrMjbg-6Q06-pzKB7jxZCMBHShFrJhrG2LRorIg5ImxNihq0esu9NnjVnerFB7_W9DXqxQbNaFxsK682D_rTpwT1y_u69AD4eAFCmvPWQNVoP0YLzGeyoXfL_aXD6D98GH7014SfMgPs05VgWqLnGQtDflktYDoEzxuqyAnEHNd2y3w</recordid><startdate>20101001</startdate><enddate>20101001</enddate><creator>Oertel, Wolfgang H</creator><creator>Beneš, Heike</creator><creator>Garcia-Borreguero, Diego</creator><creator>Högl, Birgit</creator><creator>Poewe, Werner</creator><creator>Montagna, Pasquale</creator><creator>Ferini-Strambi, Luigi</creator><creator>Sixel-Döring, Friederike</creator><creator>Trenkwalder, Claudia</creator><creator>Partinen, Markku</creator><creator>Saletu, Bernd</creator><creator>Polo, Olli</creator><creator>Fichtner, Andreas</creator><creator>Schollmayer, Erwin</creator><creator>Kohnen, Ralf</creator><creator>Cassel, Werner</creator><creator>Penzel, Thomas</creator><creator>Stiasny-Kolster, Karin</creator><general>Elsevier B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20101001</creationdate><title>Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: A randomized, placebo-controlled polysomnographic study</title><author>Oertel, Wolfgang H ; Beneš, Heike ; Garcia-Borreguero, Diego ; Högl, Birgit ; Poewe, Werner ; Montagna, Pasquale ; Ferini-Strambi, Luigi ; Sixel-Döring, Friederike ; Trenkwalder, Claudia ; Partinen, Markku ; Saletu, Bernd ; Polo, Olli ; Fichtner, Andreas ; Schollmayer, Erwin ; Kohnen, Ralf ; Cassel, Werner ; Penzel, Thomas ; Stiasny-Kolster, Karin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c413t-4ad3c63b32270a4d8513f1cbae3a5dec4772703e15e7d721c68dc68de05c765f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Dopamine agonist</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Idiopathic restless legs syndrome</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Movement - drug effects</topic><topic>Neurology</topic><topic>Periodic limb movement</topic><topic>Polysomnography</topic><topic>Restless Legs Syndrome - drug therapy</topic><topic>Rotigotine</topic><topic>Severity of Illness Index</topic><topic>Sleep</topic><topic>Sleep Medicine</topic><topic>Tetrahydronaphthalenes - administration & dosage</topic><topic>Tetrahydronaphthalenes - adverse effects</topic><topic>Tetrahydronaphthalenes - therapeutic use</topic><topic>Thiophenes - administration & dosage</topic><topic>Thiophenes - adverse effects</topic><topic>Thiophenes - therapeutic use</topic><topic>Transdermal Patch</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Oertel, Wolfgang H</creatorcontrib><creatorcontrib>Beneš, Heike</creatorcontrib><creatorcontrib>Garcia-Borreguero, Diego</creatorcontrib><creatorcontrib>Högl, Birgit</creatorcontrib><creatorcontrib>Poewe, Werner</creatorcontrib><creatorcontrib>Montagna, Pasquale</creatorcontrib><creatorcontrib>Ferini-Strambi, Luigi</creatorcontrib><creatorcontrib>Sixel-Döring, Friederike</creatorcontrib><creatorcontrib>Trenkwalder, Claudia</creatorcontrib><creatorcontrib>Partinen, Markku</creatorcontrib><creatorcontrib>Saletu, Bernd</creatorcontrib><creatorcontrib>Polo, Olli</creatorcontrib><creatorcontrib>Fichtner, Andreas</creatorcontrib><creatorcontrib>Schollmayer, Erwin</creatorcontrib><creatorcontrib>Kohnen, Ralf</creatorcontrib><creatorcontrib>Cassel, Werner</creatorcontrib><creatorcontrib>Penzel, Thomas</creatorcontrib><creatorcontrib>Stiasny-Kolster, Karin</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Sleep medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Oertel, Wolfgang H</au><au>Beneš, Heike</au><au>Garcia-Borreguero, Diego</au><au>Högl, Birgit</au><au>Poewe, Werner</au><au>Montagna, Pasquale</au><au>Ferini-Strambi, Luigi</au><au>Sixel-Döring, Friederike</au><au>Trenkwalder, Claudia</au><au>Partinen, Markku</au><au>Saletu, Bernd</au><au>Polo, Olli</au><au>Fichtner, Andreas</au><au>Schollmayer, Erwin</au><au>Kohnen, Ralf</au><au>Cassel, Werner</au><au>Penzel, Thomas</au><au>Stiasny-Kolster, Karin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: A randomized, placebo-controlled polysomnographic study</atitle><jtitle>Sleep medicine</jtitle><addtitle>Sleep Med</addtitle><date>2010-10-01</date><risdate>2010</risdate><volume>11</volume><issue>9</issue><spage>848</spage><epage>856</epage><pages>848-856</pages><issn>1389-9457</issn><eissn>1878-5506</eissn><abstract>Abstract Objective To assess the efficacy of rotigotine transdermal patch in subjects with moderate to severe idiopathic restless legs syndrome (RLS) and periodic limb movement (PLM) in sleep in a double-blind, randomized, placebo-controlled, multicenter study ( NCT00275236 ). Methods Sixty-seven (46 rotigotine, 21 placebo) subjects applied rotigotine (maximum 3 mg/24 h) or placebo patches once-daily during a 4-week maintenance period; efficacy evaluations used polysomnographic measures and clinician/patient ratings. Results Mean PLM index (PLMI; PLM/h time in bed) decreased more with rotigotine (50.9/h to 8.1/h) than with placebo (37.4/h to 27.1/h; adjusted treatment ratio 4.25 (95% CI [2.48, 7.28], p < 0.0001). PLM during sleep with arousal index (PLMSAI; 8.57/h to 2.47/h under rotigotine, 6.5/h to 4.95/h under placebo; adjusted treatment difference: −3.12 (95% CI [−5.36, −0.88], p = 0.0072) also improved more under rotigotine. At end of maintenance, 39% of rotigotine subjects had PLMI levels <5/h and 26% showed no RLS symptoms (IRLS = 0), whereas no placebo subject met these criteria. Common drug-related adverse events for rotigotine and placebo included nausea (21.7%/4.8%), headache (17.4%/14.3%), application site reactions (17.4%/4.8%), and somnolence (10.9%/9.5%); most were mild to moderate in intensity. Conclusions Rotigotine transdermal patch was efficacious and well tolerated in the short-term treatment of RLS motor symptoms and associated sleep disturbances.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>20813583</pmid><doi>10.1016/j.sleep.2010.02.014</doi><tpages>9</tpages></addata></record> |
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| subjects | Adolescent Adult Aged Dopamine agonist Double-Blind Method Female Humans Idiopathic restless legs syndrome Male Middle Aged Movement - drug effects Neurology Periodic limb movement Polysomnography Restless Legs Syndrome - drug therapy Rotigotine Severity of Illness Index Sleep Sleep Medicine Tetrahydronaphthalenes - administration & dosage Tetrahydronaphthalenes - adverse effects Tetrahydronaphthalenes - therapeutic use Thiophenes - administration & dosage Thiophenes - adverse effects Thiophenes - therapeutic use Transdermal Patch Treatment Outcome Young Adult |
| title | Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: A randomized, placebo-controlled polysomnographic study |
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