Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study
Identifieur interne : 000D43 ( Main/Corpus ); précédent : 000D42; suivant : 000D44Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study
Auteurs : Wolfgang H. Oertel ; Erik Wolters ; Cristina Sampaio ; Santiago Gimenez-Roldan ; Bruno Bergamasco ; Max Dujardin ; Donald G. Grosset ; Guy Arnold ; Klaus L. Leenders ; Hans-Peter Hundemer ; Alberto Lled ; Andrew Wood ; Paul Frewer ; Johannes SchwarzSource :
- Movement Disorders [ 0885-3185 ] ; 2006-03.
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- KwdEn :
Abstract
Dopamine agonists are used as initial treatment in patients with Parkinson's disease (PD) to reduce incidence and severity of motor complications. This paradigm is based on long‐term studies, allowing “rescue” therapy with levodopa. The present strict monotherapy study (PELMOPET, the acronym for the pergolide‐versus‐L‐dopa‐monotherapy‐and‐positron‐emission‐tomography trial) evaluated the efficacy and safety of pergolide versus levodopa without levodopa “rescue” medication. This multicenter, double‐blind, randomized, 3‐year trial compared pergolide monotherapy (n = 148) with levodopa monotherapy (n = 146) in dopamine‐naive patients with early PD (Hoehn and Yahr stage 1–2.5). Primary efficacy measures were clinical efficacy, severity and time to onset of motor complications, and disease progression. During the 3 years, severity of motor complications was significantly lower and time to onset of dyskinesia was significantly delayed in the group receiving pergolide (3.23 mg/day) compared with those receiving levodopa (504 mg/day). However, time to onset of motor complications was not longer in patients receiving pergolide after 3 years. Symptomatic relief (assessed by Unified Parkinson's Disease Rating Scale [UPDRS], UPDRS II, and III, Clinical Global Impressions [CGI] severity, and CGI and Patient Global Impressions [PGI] improvement) was significantly greater in patients receiving levodopa. Adverse events led to discontinuation of therapy in 17.6% of pergolide patients and 9.6% of levodopa patients. This is the first study comparing strict monotherapy with a dopamine agonist versus levodopa in previously untreated early PD. In principle, both levodopa and a dopamine agonist such as pergolide seem to be suitable options as initial PD therapy. The choice remains with the treating physician based on the different efficacy and adverse event profiles. © 2005 Movement Disorder Society
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DOI: 10.1002/mds.20724
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ISTEX:794E028842114FBFD068AA3D5F8BCDDDDA18D100Le document en format XML
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Oertel</name><affiliation><mods:affiliation>Department of Neurology, Philipps‐University, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Wolters, Erik" sort="Wolters, Erik" uniqKey="Wolters E" first="Erik" last="Wolters">Erik Wolters</name><affiliation><mods:affiliation>Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Sampaio, Cristina" sort="Sampaio, Cristina" uniqKey="Sampaio C" first="Cristina" last="Sampaio">Cristina Sampaio</name><affiliation><mods:affiliation>Instituto de Farmacologia e Terapêutica Geral, Faculdade de Medicina de Lisboa, Hospital de Santa Maria, Lisbon, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Gimenez Oldan, Santiago" sort="Gimenez Oldan, Santiago" uniqKey="Gimenez Oldan S" first="Santiago" last="Gimenez-Roldan">Santiago Gimenez-Roldan</name><affiliation><mods:affiliation>Department of Neurology, University Gregorio Maranon, Madrid, Spain</mods:affiliation></affiliation></author><author><name sortKey="Bergamasco, Bruno" sort="Bergamasco, Bruno" uniqKey="Bergamasco B" first="Bruno" last="Bergamasco">Bruno Bergamasco</name><affiliation><mods:affiliation>Department of Neurology, University Hospital, Turino, Italy</mods:affiliation></affiliation></author><author><name sortKey="Dujardin, Max" sort="Dujardin, Max" uniqKey="Dujardin M" first="Max" last="Dujardin">Max Dujardin</name><affiliation><mods:affiliation>Department of Neurology, Evreux, France</mods:affiliation></affiliation></author><author><name sortKey="Grosset, Donald G" sort="Grosset, Donald G" uniqKey="Grosset D" first="Donald G." last="Grosset">Donald G. 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Oertel</name><affiliation><mods:affiliation>Department of Neurology, Philipps‐University, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Wolters, Erik" sort="Wolters, Erik" uniqKey="Wolters E" first="Erik" last="Wolters">Erik Wolters</name><affiliation><mods:affiliation>Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Sampaio, Cristina" sort="Sampaio, Cristina" uniqKey="Sampaio C" first="Cristina" last="Sampaio">Cristina Sampaio</name><affiliation><mods:affiliation>Instituto de Farmacologia e Terapêutica Geral, Faculdade de Medicina de Lisboa, Hospital de Santa Maria, Lisbon, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Gimenez Oldan, Santiago" sort="Gimenez Oldan, Santiago" uniqKey="Gimenez Oldan S" first="Santiago" last="Gimenez-Roldan">Santiago Gimenez-Roldan</name><affiliation><mods:affiliation>Department of Neurology, University Gregorio Maranon, Madrid, Spain</mods:affiliation></affiliation></author><author><name sortKey="Bergamasco, Bruno" sort="Bergamasco, Bruno" uniqKey="Bergamasco B" first="Bruno" last="Bergamasco">Bruno Bergamasco</name><affiliation><mods:affiliation>Department of Neurology, University Hospital, Turino, Italy</mods:affiliation></affiliation></author><author><name sortKey="Dujardin, Max" sort="Dujardin, Max" uniqKey="Dujardin M" first="Max" last="Dujardin">Max Dujardin</name><affiliation><mods:affiliation>Department of Neurology, Evreux, France</mods:affiliation></affiliation></author><author><name sortKey="Grosset, Donald G" sort="Grosset, Donald G" uniqKey="Grosset D" first="Donald G." last="Grosset">Donald G. Grosset</name><affiliation><mods:affiliation>Institute of Neurology, Southern General Hospital, Glasgow, Scotland</mods:affiliation></affiliation></author><author><name sortKey="Arnold, Guy" sort="Arnold, Guy" uniqKey="Arnold G" first="Guy" last="Arnold">Guy Arnold</name><affiliation><mods:affiliation>Department of Neurology, Charite, Berlin, Germany</mods:affiliation></affiliation></author><author><name sortKey="Leenders, Klaus L" sort="Leenders, Klaus L" uniqKey="Leenders K" first="Klaus L." last="Leenders">Klaus L. Leenders</name><affiliation><mods:affiliation>Department of Neurology, University Hospital Groningen, Groningen, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Hundemer, Hans Eter" sort="Hundemer, Hans Eter" uniqKey="Hundemer H" first="Hans-Peter" last="Hundemer">Hans-Peter Hundemer</name><affiliation><mods:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</mods:affiliation></affiliation></author><author><name sortKey="Lled, Alberto" sort="Lled, Alberto" uniqKey="Lled A" first="Alberto" last="Lled">Alberto Lled</name><affiliation><mods:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</mods:affiliation></affiliation></author><author><name sortKey="Wood, Andrew" sort="Wood, Andrew" uniqKey="Wood A" first="Andrew" last="Wood">Andrew Wood</name><affiliation><mods:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</mods:affiliation></affiliation></author><author><name sortKey="Frewer, Paul" sort="Frewer, Paul" uniqKey="Frewer P" first="Paul" last="Frewer">Paul Frewer</name><affiliation><mods:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</mods:affiliation></affiliation></author><author><name sortKey="Schwarz, Johannes" sort="Schwarz, Johannes" uniqKey="Schwarz J" first="Johannes" last="Schwarz">Johannes Schwarz</name><affiliation><mods:affiliation>Department of Neurology, University Hospital Leipzig, Leipzig, Germany</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2006-03">2006-03</date><biblScope unit="volume">21</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="343">343</biblScope><biblScope unit="page" to="353">353</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">794E028842114FBFD068AA3D5F8BCDDDDA18D100</idno><idno type="DOI">10.1002/mds.20724</idno><idno type="ArticleID">MDS20724</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>PELMOPET</term><term>Parkinson's disease</term><term>dyskinesia</term><term>levodopa</term><term>monotherapy</term><term>motor complications</term><term>pergolide</term><term>symptomatic effect</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Dopamine agonists are used as initial treatment in patients with Parkinson's disease (PD) to reduce incidence and severity of motor complications. This paradigm is based on long‐term studies, allowing “rescue” therapy with levodopa. The present strict monotherapy study (PELMOPET, the acronym for the pergolide‐versus‐L‐dopa‐monotherapy‐and‐positron‐emission‐tomography trial) evaluated the efficacy and safety of pergolide versus levodopa without levodopa “rescue” medication. This multicenter, double‐blind, randomized, 3‐year trial compared pergolide monotherapy (n = 148) with levodopa monotherapy (n = 146) in dopamine‐naive patients with early PD (Hoehn and Yahr stage 1–2.5). Primary efficacy measures were clinical efficacy, severity and time to onset of motor complications, and disease progression. During the 3 years, severity of motor complications was significantly lower and time to onset of dyskinesia was significantly delayed in the group receiving pergolide (3.23 mg/day) compared with those receiving levodopa (504 mg/day). However, time to onset of motor complications was not longer in patients receiving pergolide after 3 years. Symptomatic relief (assessed by Unified Parkinson's Disease Rating Scale [UPDRS], UPDRS II, and III, Clinical Global Impressions [CGI] severity, and CGI and Patient Global Impressions [PGI] improvement) was significantly greater in patients receiving levodopa. Adverse events led to discontinuation of therapy in 17.6% of pergolide patients and 9.6% of levodopa patients. This is the first study comparing strict monotherapy with a dopamine agonist versus levodopa in previously untreated early PD. In principle, both levodopa and a dopamine agonist such as pergolide seem to be suitable options as initial PD therapy. The choice remains with the treating physician based on the different efficacy and adverse event profiles. © 2005 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Wolfgang H. Oertel MD</name><affiliations><json:string>Department of Neurology, Philipps‐University, Marburg, Germany</json:string></affiliations></json:item><json:item><name>Erik Wolters MD</name><affiliations><json:string>Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands</json:string></affiliations></json:item><json:item><name>Cristina Sampaio MD, PhD</name><affiliations><json:string>Instituto de Farmacologia e Terapêutica Geral, Faculdade de Medicina de Lisboa, Hospital de Santa Maria, Lisbon, Portugal</json:string></affiliations></json:item><json:item><name>Santiago Gimenez‐Roldan MD</name><affiliations><json:string>Department of Neurology, University Gregorio Maranon, Madrid, Spain</json:string></affiliations></json:item><json:item><name>Bruno Bergamasco MD</name><affiliations><json:string>Department of Neurology, University Hospital, Turino, Italy</json:string></affiliations></json:item><json:item><name>Max Dujardin MD</name><affiliations><json:string>Department of Neurology, Evreux, France</json:string></affiliations></json:item><json:item><name>Donald G. Grosset MD</name><affiliations><json:string>Institute of Neurology, Southern General Hospital, Glasgow, Scotland</json:string></affiliations></json:item><json:item><name>Guy Arnold MD</name><affiliations><json:string>Department of Neurology, Charite, Berlin, Germany</json:string></affiliations></json:item><json:item><name>Klaus L. Leenders MD</name><affiliations><json:string>Department of Neurology, University Hospital Groningen, Groningen, The Netherlands</json:string></affiliations></json:item><json:item><name>Hans‐Peter Hundemer MD</name><affiliations><json:string>Eli Lilly and Company, Indianapolis, Indiana, USA</json:string></affiliations></json:item><json:item><name>Alberto Lledó MD, PhD</name><affiliations><json:string>Eli Lilly and Company, Indianapolis, Indiana, USA</json:string></affiliations></json:item><json:item><name>Andrew Wood MD</name><affiliations><json:string>Eli Lilly and Company, Indianapolis, Indiana, USA</json:string></affiliations></json:item><json:item><name>Paul Frewer MS</name><affiliations><json:string>Eli Lilly and Company, Indianapolis, Indiana, USA</json:string></affiliations></json:item><json:item><name>Johannes Schwarz MD</name><affiliations><json:string>Department of Neurology, University Hospital Leipzig, Leipzig, Germany</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>pergolide</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>levodopa</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>motor complications</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>dyskinesia</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>monotherapy</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>symptomatic effect</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>PELMOPET</value></json:item></subject><articleId><json:string>MDS20724</json:string></articleId><language><json:string>eng</json:string></language><abstract>Dopamine agonists are used as initial treatment in patients with Parkinson's disease (PD) to reduce incidence and severity of motor complications. This paradigm is based on long‐term studies, allowing “rescue” therapy with levodopa. The present strict monotherapy study (PELMOPET, the acronym for the pergolide‐versus‐L‐dopa‐monotherapy‐and‐positron‐emission‐tomography trial) evaluated the efficacy and safety of pergolide versus levodopa without levodopa “rescue” medication. This multicenter, double‐blind, randomized, 3‐year trial compared pergolide monotherapy (n = 148) with levodopa monotherapy (n = 146) in dopamine‐naive patients with early PD (Hoehn and Yahr stage 1–2.5). Primary efficacy measures were clinical efficacy, severity and time to onset of motor complications, and disease progression. During the 3 years, severity of motor complications was significantly lower and time to onset of dyskinesia was significantly delayed in the group receiving pergolide (3.23 mg/day) compared with those receiving levodopa (504 mg/day). However, time to onset of motor complications was not longer in patients receiving pergolide after 3 years. Symptomatic relief (assessed by Unified Parkinson's Disease Rating Scale [UPDRS], UPDRS II, and III, Clinical Global Impressions [CGI] severity, and CGI and Patient Global Impressions [PGI] improvement) was significantly greater in patients receiving levodopa. Adverse events led to discontinuation of therapy in 17.6% of pergolide patients and 9.6% of levodopa patients. This is the first study comparing strict monotherapy with a dopamine agonist versus levodopa in previously untreated early PD. In principle, both levodopa and a dopamine agonist such as pergolide seem to be suitable options as initial PD therapy. 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Philipps‐University Marburg, Rudolf‐Bultmann Strasse 8, D 35033 Marburg, Germany</p></note><affiliation>Department of Neurology, Philipps‐University, Marburg, Germany</affiliation></author><author><persName><forename type="first">Erik</forename><surname>Wolters</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands</affiliation></author><author><persName><forename type="first">Cristina</forename><surname>Sampaio</surname></persName><roleName type="degree">MD, PhD</roleName><affiliation>Instituto de Farmacologia e Terapêutica Geral, Faculdade de Medicina de Lisboa, Hospital de Santa Maria, Lisbon, Portugal</affiliation></author><author><persName><forename type="first">Santiago</forename><surname>Gimenez‐Roldan</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University Gregorio Maranon, Madrid, Spain</affiliation></author><author><persName><forename type="first">Bruno</forename><surname>Bergamasco</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University Hospital, Turino, Italy</affiliation></author><author><persName><forename type="first">Max</forename><surname>Dujardin</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Evreux, France</affiliation></author><author><persName><forename type="first">Donald G.</forename><surname>Grosset</surname></persName><roleName type="degree">MD</roleName><affiliation>Institute of Neurology, Southern General Hospital, Glasgow, Scotland</affiliation></author><author><persName><forename type="first">Guy</forename><surname>Arnold</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Charite, Berlin, Germany</affiliation></author><author><persName><forename type="first">Klaus L.</forename><surname>Leenders</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University Hospital Groningen, Groningen, The Netherlands</affiliation></author><author><persName><forename type="first">Hans‐Peter</forename><surname>Hundemer</surname></persName><roleName type="degree">MD</roleName><affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</affiliation></author><author><persName><forename type="first">Alberto</forename><surname>Lledó</surname></persName><roleName type="degree">MD, PhD</roleName><affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</affiliation></author><author><persName><forename type="first">Andrew</forename><surname>Wood</surname></persName><roleName type="degree">MD</roleName><affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</affiliation></author><author><persName><forename type="first">Paul</forename><surname>Frewer</surname></persName><roleName type="degree">MS</roleName><affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</affiliation></author><author><persName><forename type="first">Johannes</forename><surname>Schwarz</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University Hospital Leipzig, Leipzig, Germany</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2006-03"></date><biblScope unit="volume">21</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="343">343</biblScope><biblScope unit="page" to="353">353</biblScope></imprint></monogr><idno type="istex">794E028842114FBFD068AA3D5F8BCDDDDA18D100</idno><idno type="DOI">10.1002/mds.20724</idno><idno type="ArticleID">MDS20724</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2006</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Dopamine agonists are used as initial treatment in patients with Parkinson's disease (PD) to reduce incidence and severity of motor complications. This paradigm is based on long‐term studies, allowing “rescue” therapy with levodopa. The present strict monotherapy study (PELMOPET, the acronym for the pergolide‐versus‐L‐dopa‐monotherapy‐and‐positron‐emission‐tomography trial) evaluated the efficacy and safety of pergolide versus levodopa without levodopa “rescue” medication. This multicenter, double‐blind, randomized, 3‐year trial compared pergolide monotherapy (n = 148) with levodopa monotherapy (n = 146) in dopamine‐naive patients with early PD (Hoehn and Yahr stage 1–2.5). Primary efficacy measures were clinical efficacy, severity and time to onset of motor complications, and disease progression. During the 3 years, severity of motor complications was significantly lower and time to onset of dyskinesia was significantly delayed in the group receiving pergolide (3.23 mg/day) compared with those receiving levodopa (504 mg/day). However, time to onset of motor complications was not longer in patients receiving pergolide after 3 years. Symptomatic relief (assessed by Unified Parkinson's Disease Rating Scale [UPDRS], UPDRS II, and III, Clinical Global Impressions [CGI] severity, and CGI and Patient Global Impressions [PGI] improvement) was significantly greater in patients receiving levodopa. Adverse events led to discontinuation of therapy in 17.6% of pergolide patients and 9.6% of levodopa patients. This is the first study comparing strict monotherapy with a dopamine agonist versus levodopa in previously untreated early PD. In principle, both levodopa and a dopamine agonist such as pergolide seem to be suitable options as initial PD therapy. The choice remains with the treating physician based on the different efficacy and adverse event profiles. © 2005 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>pergolide</term></item><item><term>levodopa</term></item><item><term>motor complications</term></item><item><term>dyskinesia</term></item><item><term>Parkinson's disease</term></item><item><term>monotherapy</term></item><item><term>symptomatic effect</term></item><item><term>PELMOPET</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2004-12-16">Received</change><change when="2005-07-11">Registration</change><change when="2006-03">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/794E028842114FBFD068AA3D5F8BCDDDDA18D100/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="short">Mov. Disord.</title></titleGroup></publicationMeta><publicationMeta level="part" position="30"><doi origin="wiley" registered="yes">10.1002/mds.v21:3</doi><numberingGroup><numbering type="journalVolume" number="21">21</numbering><numbering type="journalIssue">3</numbering></numberingGroup><coverDate startDate="2006-03">March 2006</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="100" status="forIssue"><doi origin="wiley" registered="yes">10.1002/mds.20724</doi><idGroup><id type="unit" value="MDS20724"></id></idGroup><countGroup><count type="pageTotal" number="11"></count></countGroup><titleGroup><title type="articleCategory">Research Article</title><title type="tocHeading1">Research Articles</title></titleGroup><copyright ownership="thirdParty">Copyright © 2005 Movement Disorder Society</copyright><eventGroup><event type="manuscriptReceived" date="2004-12-16"></event><event type="manuscriptRevised" date="2005-04-28"></event><event type="manuscriptAccepted" date="2005-07-11"></event><event type="firstOnline" date="2005-10-06"></event><event type="publishedOnlineFinalForm" date="2006-03-09"></event><event type="publishedOnlineAcceptedOrEarlyUnpaginated" date="2005-10-06"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:3.2.9 mode:FullText" date="2014-02-21"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.2.9 mode:FullText" date="2014-02-21"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-31"></event></eventGroup><numberingGroup><numbering type="pageFirst">343</numbering><numbering type="pageLast">353</numbering></numberingGroup><correspondenceTo>Department of Neurology, Philipps‐University Marburg, Rudolf‐Bultmann Strasse 8, D 35033 Marburg, Germany</correspondenceTo><objectNameGroup><objectName elementName="appendix">APPENDIX</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS20724.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="5"></count><count type="tableTotal" number="4"></count><count type="referenceTotal" number="34"></count><count type="wordTotal" number="8224"></count></countGroup><titleGroup><title type="main" xml:lang="en">Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study</title><title type="short" xml:lang="en">The PELMOPET Study</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Wolfgang H.</givenNames><familyName>Oertel</familyName><degrees>MD</degrees></personName><contactDetails><email normalForm="oertelw@med.uni-marburg.de">oertelw@med.uni‐marburg.de</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Erik</givenNames><familyName>Wolters</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Cristina</givenNames><familyName>Sampaio</familyName><degrees>MD, PhD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Santiago</givenNames><familyName>Gimenez‐Roldan</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Bruno</givenNames><familyName>Bergamasco</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Max</givenNames><familyName>Dujardin</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af7"><personName><givenNames>Donald G.</givenNames><familyName>Grosset</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af8"><personName><givenNames>Guy</givenNames><familyName>Arnold</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af9"><personName><givenNames>Klaus L.</givenNames><familyName>Leenders</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au10" creatorRole="author" affiliationRef="#af10"><personName><givenNames>Hans‐Peter</givenNames><familyName>Hundemer</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au11" creatorRole="author" affiliationRef="#af10"><personName><givenNames>Alberto</givenNames><familyName>Lledó</familyName><degrees>MD, PhD</degrees></personName></creator><creator xml:id="au12" creatorRole="author" affiliationRef="#af10"><personName><givenNames>Andrew</givenNames><familyName>Wood</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au13" creatorRole="author" affiliationRef="#af10"><personName><givenNames>Paul</givenNames><familyName>Frewer</familyName><degrees>MS</degrees></personName></creator><creator xml:id="au14" creatorRole="author" affiliationRef="#af11"><personName><givenNames>Johannes</givenNames><familyName>Schwarz</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="DE" type="organization"><unparsedAffiliation>Department of Neurology, Philipps‐University, Marburg, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="NL" type="organization"><unparsedAffiliation>Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="PT" 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type="organization"><unparsedAffiliation>Department of Neurology, Charite, Berlin, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af9" countryCode="NL" type="organization"><unparsedAffiliation>Department of Neurology, University Hospital Groningen, Groningen, The Netherlands</unparsedAffiliation></affiliation><affiliation xml:id="af10" countryCode="US" type="organization"><unparsedAffiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</unparsedAffiliation></affiliation><affiliation xml:id="af11" countryCode="DE" type="organization"><unparsedAffiliation>Department of Neurology, University Hospital Leipzig, Leipzig, Germany</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">pergolide</keyword><keyword xml:id="kwd2">levodopa</keyword><keyword xml:id="kwd3">motor complications</keyword><keyword xml:id="kwd4">dyskinesia</keyword><keyword xml:id="kwd5">Parkinson's disease</keyword><keyword xml:id="kwd6">monotherapy</keyword><keyword xml:id="kwd7">symptomatic effect</keyword><keyword xml:id="kwd8">PELMOPET</keyword></keywordGroup><fundingInfo><fundingAgency>Eli Lilly and Company, Indianapolis, IN, USA</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Dopamine agonists are used as initial treatment in patients with Parkinson's disease (PD) to reduce incidence and severity of motor complications. This paradigm is based on long‐term studies, allowing “rescue” therapy with levodopa. The present strict monotherapy study (PELMOPET, the acronym for the pergolide‐versus‐L‐dopa‐monotherapy‐and‐positron‐emission‐tomography trial) evaluated the efficacy and safety of pergolide versus levodopa without levodopa “rescue” medication. This multicenter, double‐blind, randomized, 3‐year trial compared pergolide monotherapy (n = 148) with levodopa monotherapy (n = 146) in dopamine‐naive patients with early PD (Hoehn and Yahr stage 1–2.5). Primary efficacy measures were clinical efficacy, severity and time to onset of motor complications, and disease progression. During the 3 years, severity of motor complications was significantly lower and time to onset of dyskinesia was significantly delayed in the group receiving pergolide (3.23 mg/day) compared with those receiving levodopa (504 mg/day). However, time to onset of motor complications was not longer in patients receiving pergolide after 3 years. Symptomatic relief (assessed by Unified Parkinson's Disease Rating Scale [UPDRS], UPDRS II, and III, Clinical Global Impressions [CGI] severity, and CGI and Patient Global Impressions [PGI] improvement) was significantly greater in patients receiving levodopa. Adverse events led to discontinuation of therapy in 17.6% of pergolide patients and 9.6% of levodopa patients. This is the first study comparing strict monotherapy with a dopamine agonist versus levodopa in previously untreated early PD. In principle, both levodopa and a dopamine agonist such as pergolide seem to be suitable options as initial PD therapy. The choice remains with the treating physician based on the different efficacy and adverse event profiles. © 2005 Movement Disorder Society</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>The PELMOPET Study</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study</title></titleInfo><name type="personal"><namePart type="given">Wolfgang H.</namePart><namePart type="family">Oertel</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Philipps‐University, Marburg, Germany</affiliation><description>Correspondence: Department of Neurology, Philipps‐University Marburg, Rudolf‐Bultmann Strasse 8, D 35033 Marburg, Germany</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Erik</namePart><namePart type="family">Wolters</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Cristina</namePart><namePart type="family">Sampaio</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Instituto de Farmacologia e Terapêutica Geral, Faculdade de Medicina de Lisboa, Hospital de Santa Maria, Lisbon, Portugal</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Santiago</namePart><namePart type="family">Gimenez‐Roldan</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University Gregorio Maranon, Madrid, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bruno</namePart><namePart type="family">Bergamasco</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University Hospital, Turino, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Max</namePart><namePart type="family">Dujardin</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Evreux, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Donald G.</namePart><namePart type="family">Grosset</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Institute of Neurology, Southern General Hospital, Glasgow, Scotland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Guy</namePart><namePart type="family">Arnold</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Charite, Berlin, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Klaus L.</namePart><namePart type="family">Leenders</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University Hospital Groningen, Groningen, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Hans‐Peter</namePart><namePart type="family">Hundemer</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Alberto</namePart><namePart type="family">Lledó</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Andrew</namePart><namePart type="family">Wood</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Paul</namePart><namePart type="family">Frewer</namePart><namePart type="termsOfAddress">MS</namePart><affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Johannes</namePart><namePart type="family">Schwarz</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University Hospital Leipzig, Leipzig, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2006-03</dateIssued><dateCaptured encoding="w3cdtf">2004-12-16</dateCaptured><dateValid encoding="w3cdtf">2005-07-11</dateValid><copyrightDate encoding="w3cdtf">2006</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">5</extent><extent unit="tables">4</extent><extent unit="references">34</extent><extent unit="words">8224</extent></physicalDescription><abstract lang="en">Dopamine agonists are used as initial treatment in patients with Parkinson's disease (PD) to reduce incidence and severity of motor complications. This paradigm is based on long‐term studies, allowing “rescue” therapy with levodopa. The present strict monotherapy study (PELMOPET, the acronym for the pergolide‐versus‐L‐dopa‐monotherapy‐and‐positron‐emission‐tomography trial) evaluated the efficacy and safety of pergolide versus levodopa without levodopa “rescue” medication. This multicenter, double‐blind, randomized, 3‐year trial compared pergolide monotherapy (n = 148) with levodopa monotherapy (n = 146) in dopamine‐naive patients with early PD (Hoehn and Yahr stage 1–2.5). Primary efficacy measures were clinical efficacy, severity and time to onset of motor complications, and disease progression. During the 3 years, severity of motor complications was significantly lower and time to onset of dyskinesia was significantly delayed in the group receiving pergolide (3.23 mg/day) compared with those receiving levodopa (504 mg/day). However, time to onset of motor complications was not longer in patients receiving pergolide after 3 years. Symptomatic relief (assessed by Unified Parkinson's Disease Rating Scale [UPDRS], UPDRS II, and III, Clinical Global Impressions [CGI] severity, and CGI and Patient Global Impressions [PGI] improvement) was significantly greater in patients receiving levodopa. Adverse events led to discontinuation of therapy in 17.6% of pergolide patients and 9.6% of levodopa patients. This is the first study comparing strict monotherapy with a dopamine agonist versus levodopa in previously untreated early PD. In principle, both levodopa and a dopamine agonist such as pergolide seem to be suitable options as initial PD therapy. The choice remains with the treating physician based on the different efficacy and adverse event profiles. © 2005 Movement Disorder Society</abstract><note type="funding">Eli Lilly and Company, Indianapolis, IN, USA</note><subject lang="en"><genre>Keywords</genre><topic>pergolide</topic><topic>levodopa</topic><topic>motor complications</topic><topic>dyskinesia</topic><topic>Parkinson's disease</topic><topic>monotherapy</topic><topic>symptomatic effect</topic><topic>PELMOPET</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. 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