Rotigotine Transdermal Patch in Early Parkinson's Disease : A Randomized, Double-Blind, Controlled Study Versus Placebo and Ropinirole
Identifieur interne : 001477 ( PascalFrancis/Checkpoint ); précédent : 001476; suivant : 001478Rotigotine Transdermal Patch in Early Parkinson's Disease : A Randomized, Double-Blind, Controlled Study Versus Placebo and Ropinirole
Auteurs : Nir Giladi [Israël] ; Babak Boroojerdi [Allemagne] ; Amos D. Korczyn [Israël] ; David J. Burn [Royaume-Uni] ; Carl E. Clarke [Royaume-Uni] ; Anthony H. V. Schapira [Royaume-Uni]Source :
- Movement disorders [ 0885-3185 ] ; 2007.
Descripteurs français
- Pascal (Inist)
English descriptors
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Abstract
Rotigotine is a new, non-ergot dopamine agonist formulated in a transdermal delivery system. The present study was to investigate the efficacy and safety of the rotigotine transdermal patch in the treatment of early Parkinson's disease. Patients (n = 561) were randomized to rotigotine, ropinirole, or placebo. The titration period was up to 13 weeks, and there was a minimum dose-maintenance period of 24 weeks for ropinirole and 33 weeks for rotigotine. The primary endpoint was the proportion of patients with a minimum of 20% decrease in the combined Unified Parkinson's Disease Rating Scale Part II and Part III scores. The responder rate in the rotigotine group was significantly higher than in the placebo group (52% vs. 30%, P < 0.0001). Transdermal rotigotine at doses ≤8 mg/24 h did not show noninferiority to ropinirole at doses ≤ 24 mg/day. In a post-hoc subgroup analysis, rotigotine ≤8 mg/24 hours had a similar efficacy to ropinirole at doses ≤12 mg/day. The rotigotine transdermal patch was well tolerated. The most common adverse events were application-site reactions, nausea, and somnolence. Application-site reactions were predominantly mild or moderate in intensity. In conclusion, the rotigotine transdermal patch represents an effective and safe option for the treatment of patients with early Parkinson's disease.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Rotigotine Transdermal Patch in Early Parkinson's Disease : A Randomized, Double-Blind, Controlled Study Versus Placebo and Ropinirole</title><author><name sortKey="Giladi, Nir" sort="Giladi, Nir" uniqKey="Giladi N" first="Nir" last="Giladi">Nir Giladi</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Movement Disorders Unit, Department of Neurology, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University</s1><s2>Tel Aviv</s2><s3>ISR</s3><sZ>1 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Tel Aviv</wicri:noRegion></affiliation></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>SCHWARZ PHARMA AG</s1><s2>Monheim</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>SCHWARZ PHARMA AG</wicri:noRegion><wicri:noRegion>SCHWARZ PHARMA AG</wicri:noRegion></affiliation></author><author><name sortKey="Korczyn, Amos D" sort="Korczyn, Amos D" uniqKey="Korczyn A" first="Amos D." last="Korczyn">Amos D. Korczyn</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Chair of Neurology, Sackler School of Medicine, Tel Aviv University</s1><s2>Tel Aviv</s2><s3>ISR</s3><sZ>3 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Tel Aviv</wicri:noRegion></affiliation></author><author><name sortKey="Burn, David J" sort="Burn, David J" uniqKey="Burn D" first="David J." last="Burn">David J. Burn</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Depatment of Neurology, City Hospital Birmingham and University Birmingham</s1><s3>GBR</s3><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Depatment of Neurology, City Hospital Birmingham and University Birmingham</wicri:noRegion></affiliation></author><author><name sortKey="Clarke, Carl E" sort="Clarke, Carl E" uniqKey="Clarke C" first="Carl E." last="Clarke">Carl E. Clarke</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Neurology, City Hospital NHS Trust</s1><s2>Birmingham</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Birmingham</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Midlands de l'Ouest</region></placeName></affiliation></author><author><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. Schapira</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Department of Clinical Neurosciences, Institute of Neurology</s1><s2>London</s2><s3>GBR</s3><sZ>6 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">08-0146717</idno><date when="2007">2007</date><idno type="stanalyst">PASCAL 08-0146717 INIST</idno><idno type="RBID">Pascal:08-0146717</idno><idno type="wicri:Area/PascalFrancis/Corpus">001368</idno><idno type="wicri:Area/PascalFrancis/Curation">001951</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001477</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Rotigotine Transdermal Patch in Early Parkinson's Disease : A Randomized, Double-Blind, Controlled Study Versus Placebo and Ropinirole</title><author><name sortKey="Giladi, Nir" sort="Giladi, Nir" uniqKey="Giladi N" first="Nir" last="Giladi">Nir Giladi</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Movement Disorders Unit, Department of Neurology, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University</s1><s2>Tel Aviv</s2><s3>ISR</s3><sZ>1 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Tel Aviv</wicri:noRegion></affiliation></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>SCHWARZ PHARMA AG</s1><s2>Monheim</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>SCHWARZ PHARMA AG</wicri:noRegion><wicri:noRegion>SCHWARZ PHARMA AG</wicri:noRegion></affiliation></author><author><name sortKey="Korczyn, Amos D" sort="Korczyn, Amos D" uniqKey="Korczyn A" first="Amos D." last="Korczyn">Amos D. Korczyn</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Chair of Neurology, Sackler School of Medicine, Tel Aviv University</s1><s2>Tel Aviv</s2><s3>ISR</s3><sZ>3 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Tel Aviv</wicri:noRegion></affiliation></author><author><name sortKey="Burn, David J" sort="Burn, David J" uniqKey="Burn D" first="David J." last="Burn">David J. Burn</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Depatment of Neurology, City Hospital Birmingham and University Birmingham</s1><s3>GBR</s3><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Depatment of Neurology, City Hospital Birmingham and University Birmingham</wicri:noRegion></affiliation></author><author><name sortKey="Clarke, Carl E" sort="Clarke, Carl E" uniqKey="Clarke C" first="Carl E." last="Clarke">Carl E. Clarke</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Neurology, City Hospital NHS Trust</s1><s2>Birmingham</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Birmingham</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Midlands de l'Ouest</region></placeName></affiliation></author><author><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. Schapira</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Department of Clinical Neurosciences, Institute of Neurology</s1><s2>London</s2><s3>GBR</s3><sZ>6 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Comparative study</term><term>Dopamine agonist</term><term>Double blind study</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Patch</term><term>Placebo</term><term>Ropinirole</term><term>Rotigotine</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Rotigotine</term><term>Patch</term><term>Etude double insu</term><term>Etude comparative</term><term>Placebo</term><term>Ropinirole</term><term>Stimulant dopaminergique</term><term>Traitement</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Rotigotine is a new, non-ergot dopamine agonist formulated in a transdermal delivery system. The present study was to investigate the efficacy and safety of the rotigotine transdermal patch in the treatment of early Parkinson's disease. Patients (n = 561) were randomized to rotigotine, ropinirole, or placebo. The titration period was up to 13 weeks, and there was a minimum dose-maintenance period of 24 weeks for ropinirole and 33 weeks for rotigotine. The primary endpoint was the proportion of patients with a minimum of 20% decrease in the combined Unified Parkinson's Disease Rating Scale Part II and Part III scores. The responder rate in the rotigotine group was significantly higher than in the placebo group (52% vs. 30%, P < 0.0001). Transdermal rotigotine at doses ≤8 mg/24 h did not show noninferiority to ropinirole at doses ≤ 24 mg/day. In a post-hoc subgroup analysis, rotigotine ≤8 mg/24 hours had a similar efficacy to ropinirole at doses ≤12 mg/day. The rotigotine transdermal patch was well tolerated. The most common adverse events were application-site reactions, nausea, and somnolence. Application-site reactions were predominantly mild or moderate in intensity. In conclusion, the rotigotine transdermal patch represents an effective and safe option for the treatment of patients with early Parkinson's disease.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0885-3185</s0></fA01><fA03 i2="1"><s0>Mov. disord.</s0></fA03><fA05><s2>22</s2></fA05><fA06><s2>16</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Rotigotine Transdermal Patch in Early Parkinson's Disease : A Randomized, Double-Blind, Controlled Study Versus Placebo and Ropinirole</s1></fA08><fA11 i1="01" i2="1"><s1>GILADI (Nir)</s1></fA11><fA11 i1="02" i2="1"><s1>BOROOJERDI (Babak)</s1></fA11><fA11 i1="03" i2="1"><s1>KORCZYN (Amos D.)</s1></fA11><fA11 i1="04" i2="1"><s1>BURN (David J.)</s1></fA11><fA11 i1="05" i2="1"><s1>CLARKE (Carl E.)</s1></fA11><fA11 i1="06" i2="1"><s1>SCHAPIRA (Anthony H. V.)</s1></fA11><fA14 i1="01"><s1>Movement Disorders Unit, Department of Neurology, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University</s1><s2>Tel Aviv</s2><s3>ISR</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>SCHWARZ PHARMA AG</s1><s2>Monheim</s2><s3>DEU</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Chair of Neurology, Sackler School of Medicine, Tel Aviv University</s1><s2>Tel Aviv</s2><s3>ISR</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Depatment of Neurology, City Hospital Birmingham and University Birmingham</s1><s3>GBR</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Department of Neurology, City Hospital NHS Trust</s1><s2>Birmingham</s2><s3>GBR</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Department of Clinical Neurosciences, Institute of Neurology</s1><s2>London</s2><s3>GBR</s3><sZ>6 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>SP513 investigators</s1><s3>GBR</s3></fA17><fA20><s1>2398-2404</s1></fA20><fA21><s1>2007</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000162715700150</s5></fA43><fA44><s0>0000</s0><s1>© 2008 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>27 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>08-0146717</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Movement disorders</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>Rotigotine is a new, non-ergot dopamine agonist formulated in a transdermal delivery system. The present study was to investigate the efficacy and safety of the rotigotine transdermal patch in the treatment of early Parkinson's disease. Patients (n = 561) were randomized to rotigotine, ropinirole, or placebo. The titration period was up to 13 weeks, and there was a minimum dose-maintenance period of 24 weeks for ropinirole and 33 weeks for rotigotine. The primary endpoint was the proportion of patients with a minimum of 20% decrease in the combined Unified Parkinson's Disease Rating Scale Part II and Part III scores. The responder rate in the rotigotine group was significantly higher than in the placebo group (52% vs. 30%, P < 0.0001). Transdermal rotigotine at doses ≤8 mg/24 h did not show noninferiority to ropinirole at doses ≤ 24 mg/day. In a post-hoc subgroup analysis, rotigotine ≤8 mg/24 hours had a similar efficacy to ropinirole at doses ≤12 mg/day. The rotigotine transdermal patch was well tolerated. The most common adverse events were application-site reactions, nausea, and somnolence. Application-site reactions were predominantly mild or moderate in intensity. 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Korczyn</name></country><country name="Allemagne"><noRegion><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Burn, David J" sort="Burn, David J" uniqKey="Burn D" first="David J." last="Burn">David J. Burn</name></noRegion><name sortKey="Clarke, Carl E" sort="Clarke, Carl E" uniqKey="Clarke C" first="Carl E." last="Clarke">Carl E. Clarke</name><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. Schapira</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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