Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study
Identifieur interne : 000B84 ( Main/Curation ); précédent : 000B83; suivant : 000B85Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study
Auteurs : Wolfgang H. Oertel [Allemagne] ; Erik Wolters [Pays-Bas] ; Cristina Sampaio [Portugal] ; Santiago Gimenez-Roldan [Espagne] ; Bruno Bergamasco [Italie] ; Max Dujardin [France] ; Donald G. Grosset [Royaume-Uni] ; Guy Arnold [Allemagne] ; Klaus L. Leenders [Pays-Bas] ; Hans-Peter Hundemer [États-Unis] ; Alberto Lled [États-Unis] ; Andrew Wood [États-Unis] ; Paul Frewer [États-Unis] ; Johannes Schwarz [Allemagne]Source :
- Movement Disorders [ 0885-3185 ] ; 2006-03.
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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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Oertel</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Philipps‐University, Marburg, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, Philipps‐University, Marburg</wicri:regionArea></affiliation></author><author><name sortKey="Wolters, Erik" sort="Wolters, Erik" uniqKey="Wolters E" first="Erik" last="Wolters">Erik Wolters</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands</mods:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, VU University Medical Center, Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Sampaio, Cristina" sort="Sampaio, Cristina" uniqKey="Sampaio C" first="Cristina" last="Sampaio">Cristina Sampaio</name><affiliation wicri:level="1"><mods:affiliation>Instituto de Farmacologia e Terapêutica Geral, Faculdade de Medicina de Lisboa, Hospital de Santa Maria, Lisbon, Portugal</mods:affiliation><country xml:lang="fr">Portugal</country><wicri:regionArea>Instituto de Farmacologia e Terapêutica Geral, Faculdade de Medicina de Lisboa, Hospital de Santa Maria, Lisbon</wicri:regionArea></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 wicri:level="1"><mods:affiliation>Department of Neurology, University Gregorio Maranon, Madrid, Spain</mods:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Neurology, University Gregorio Maranon, Madrid</wicri:regionArea></affiliation></author><author><name sortKey="Bergamasco, Bruno" sort="Bergamasco, Bruno" uniqKey="Bergamasco B" first="Bruno" last="Bergamasco">Bruno Bergamasco</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University Hospital, Turino, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurology, University Hospital, Turino</wicri:regionArea></affiliation></author><author><name sortKey="Dujardin, Max" sort="Dujardin, Max" uniqKey="Dujardin M" first="Max" last="Dujardin">Max Dujardin</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Evreux, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Neurology, Evreux</wicri:regionArea></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 wicri:level="2"><mods:affiliation>Institute of Neurology, Southern General Hospital, Glasgow, Scotland</mods:affiliation><country>Royaume-Uni</country><placeName><region type="country">Écosse</region></placeName><wicri:cityArea>Institute of Neurology, Southern General Hospital, Glasgow</wicri:cityArea></affiliation></author><author><name sortKey="Arnold, Guy" sort="Arnold, Guy" uniqKey="Arnold G" first="Guy" last="Arnold">Guy Arnold</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Charite, Berlin, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, Charite, Berlin</wicri:regionArea></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 wicri:level="1"><mods:affiliation>Department of Neurology, University Hospital Groningen, Groningen, The Netherlands</mods:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, University Hospital Groningen, Groningen</wicri:regionArea></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 wicri:level="1"><mods:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea></affiliation></author><author><name sortKey="Lled, Alberto" sort="Lled, Alberto" uniqKey="Lled A" first="Alberto" last="Lled">Alberto Lled</name><affiliation wicri:level="1"><mods:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea></affiliation></author><author><name sortKey="Wood, Andrew" sort="Wood, Andrew" uniqKey="Wood A" first="Andrew" last="Wood">Andrew Wood</name><affiliation wicri:level="1"><mods:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea></affiliation></author><author><name sortKey="Frewer, Paul" sort="Frewer, Paul" uniqKey="Frewer P" first="Paul" last="Frewer">Paul Frewer</name><affiliation wicri:level="1"><mods:affiliation>Eli Lilly and Company, Indianapolis, Indiana, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Eli Lilly and Company, Indianapolis, Indiana</wicri:regionArea></affiliation></author><author><name sortKey="Schwarz, Johannes" sort="Schwarz, Johannes" uniqKey="Schwarz J" first="Johannes" last="Schwarz">Johannes Schwarz</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University Hospital Leipzig, Leipzig, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, University Hospital Leipzig, Leipzig</wicri:regionArea></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></record>Pour manipuler ce document sous Unix (Dilib)
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