Early institution of bromocriptine in Parkinson's disease inhibits the emergence of levodopa-associated motor side effects. Long-term results of the PRADO study
Identifieur interne : 000B96 ( Main/Corpus ); précédent : 000B95; suivant : 000B97Early institution of bromocriptine in Parkinson's disease inhibits the emergence of levodopa-associated motor side effects. Long-term results of the PRADO study
Auteurs : H. Przuntek ; D. Welzel ; M. Gerlach ; E. Blümner ; W. Danielczyk ; -J. Kaiser ; H. Kraus ; H. Letzel ; P. Riederer ; K. ÜberlaSource :
- Journal of Neural Transmission [ 0300-9564 ] ; 1996-06-01.
Abstract
Summary: Long-term levodopa treatment in Parkinson's disease is typically associated with “motor side effects” consisting in dyskinesias and/or fluctuations in motility referred to as the on-off phenomena. The main objective of this prospective, randomized, multi-centre study was to determine to what extent the development of such complications could be prevented by partial substitution of levodopa monotherapy (L-DOPA/benserazide) by bromocriptine in patients with early symptoms of the disease. The basic trial population included 674 newly diagnosed Parkinsonian patients that were randomly allocated to monotherapy with levodopa or a combination therapy based upon a nearly 40% replacement of levodopa by bromocriptine. The two target regimens had to be consistently maintained for 42 months. Parkinsonian symptoms were assessed by means of the Webster rating scale, the Hoehn and Yahr scale, and the Zung Self-Rating Depression scale. Motor side effects and adverse events were recorded at each regular clinic visit. Neurological symptoms improved and stabilized in a similar manner during treatment with both regimens throughout the study period. Motor side effects were observed in more patients on levodopa alone than on combination therapy (28.8 vs 20%; p=0.008). According to Kaplan-Meier estimates the cumulative probability of experiencing motor side effects was 0.43 on monotherapy, compared to 0.28 on combination therapy, which was equal to a one third reduction of risk (p=0.025). In regard to motor side effects, the degree of substitution of levodopa proved relevant: patients with >50% substitution by bromocriptine exhibited half the risk observed in those with <30% (p=0.045). The overall burden of motor side effects, as reflected by a sum score based upon the relevance, the severity and the extent of motor dysfunction, was also significantly less on combination therapy (p=0.046). In conclusion, partial substitution of levodopa by bromocriptine (>30%) as first-line treatment of Parkinson's disease proves active in the prophylaxis of levodopa associated motor side effects. Early combination therapy therefore extends the period of optimal disease control.
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DOI: 10.1007/BF01271230
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Early institution of bromocriptine in Parkinson's disease inhibits the emergence of levodopa-associated motor side effects. Long-term results of the PRADO study</title><author><name sortKey="Przuntek, H" sort="Przuntek, H" uniqKey="Przuntek H" first="H." last="Przuntek">H. Przuntek</name><affiliation><mods:affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</mods:affiliation></affiliation></author><author><name sortKey="Welzel, D" sort="Welzel, D" uniqKey="Welzel D" first="D." last="Welzel">D. Welzel</name><affiliation><mods:affiliation>Institut für Pharmakologie, Universität Regensburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Gerlach, M" sort="Gerlach, M" uniqKey="Gerlach M" first="M." last="Gerlach">M. Gerlach</name><affiliation><mods:affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</mods:affiliation></affiliation><affiliation><mods:affiliation>Klinische Neurochemie, Universitäts-Nervenklinik, Würzburg</mods:affiliation></affiliation></author><author><name sortKey="Blumner, E" sort="Blumner, E" uniqKey="Blumner E" first="E." last="Blümner">E. Blümner</name><affiliation><mods:affiliation>Staticon, Medizinische Forschungsgesellschaft mbH, Planegg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Danielczyk, W" sort="Danielczyk, W" uniqKey="Danielczyk W" first="W." last="Danielczyk">W. Danielczyk</name><affiliation><mods:affiliation>Neurologische Abteilung, Pflegeheim der Stadt Wien-Lainz, Ludwig-Boltzmann-Institut für Altersforschung, Vienna, Austria</mods:affiliation></affiliation></author><author><name sortKey="Kaiser, J" sort="Kaiser, J" uniqKey="Kaiser " first="-J." last="Kaiser">-J. 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Przuntek</name><affiliation><mods:affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</mods:affiliation></affiliation></author><author><name sortKey="Welzel, D" sort="Welzel, D" uniqKey="Welzel D" first="D." last="Welzel">D. Welzel</name><affiliation><mods:affiliation>Institut für Pharmakologie, Universität Regensburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Gerlach, M" sort="Gerlach, M" uniqKey="Gerlach M" first="M." last="Gerlach">M. Gerlach</name><affiliation><mods:affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</mods:affiliation></affiliation><affiliation><mods:affiliation>Klinische Neurochemie, Universitäts-Nervenklinik, Würzburg</mods:affiliation></affiliation></author><author><name sortKey="Blumner, E" sort="Blumner, E" uniqKey="Blumner E" first="E." last="Blümner">E. Blümner</name><affiliation><mods:affiliation>Staticon, Medizinische Forschungsgesellschaft mbH, Planegg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Danielczyk, W" sort="Danielczyk, W" uniqKey="Danielczyk W" first="W." last="Danielczyk">W. Danielczyk</name><affiliation><mods:affiliation>Neurologische Abteilung, Pflegeheim der Stadt Wien-Lainz, Ludwig-Boltzmann-Institut für Altersforschung, Vienna, Austria</mods:affiliation></affiliation></author><author><name sortKey="Kaiser, J" sort="Kaiser, J" uniqKey="Kaiser " first="-J." last="Kaiser">-J. Kaiser</name><affiliation><mods:affiliation>Sandoz AG, Nuremberg</mods:affiliation></affiliation></author><author><name sortKey="Kraus, H" sort="Kraus, H" uniqKey="Kraus H" first="H." last="Kraus">H. Kraus</name><affiliation><mods:affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</mods:affiliation></affiliation></author><author><name sortKey="Letzel, H" sort="Letzel, H" uniqKey="Letzel H" first="H." last="Letzel">H. Letzel</name><affiliation><mods:affiliation>Staticon, Medizinische Forschungsgesellschaft mbH, Planegg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Riederer, P" sort="Riederer, P" uniqKey="Riederer P" first="P." last="Riederer">P. Riederer</name><affiliation><mods:affiliation>Klinische Neurochemie, Universitäts-Nervenklinik, Würzburg</mods:affiliation></affiliation></author><author><name sortKey="Uberla, K" sort="Uberla, K" uniqKey="Uberla K" first="K." last="Überla">K. 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Neural Transmission</title><idno type="ISSN">0300-9564</idno><idno type="eISSN">1435-1463</idno><imprint><publisher>Springer-Verlag</publisher><pubPlace>Vienna</pubPlace><date type="published" when="1996-06-01">1996-06-01</date><biblScope unit="volume">103</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="699">699</biblScope><biblScope unit="page" to="715">715</biblScope></imprint><idno type="ISSN">0300-9564</idno></series><idno type="istex">C1B49CBEEDEF204DF74573AD4429D84F056BF7FC</idno><idno type="DOI">10.1007/BF01271230</idno><idno type="ArticleID">Art6</idno><idno type="ArticleID">BF01271230</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0300-9564</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Summary: Long-term levodopa treatment in Parkinson's disease is typically associated with “motor side effects” consisting in dyskinesias and/or fluctuations in motility referred to as the on-off phenomena. The main objective of this prospective, randomized, multi-centre study was to determine to what extent the development of such complications could be prevented by partial substitution of levodopa monotherapy (L-DOPA/benserazide) by bromocriptine in patients with early symptoms of the disease. The basic trial population included 674 newly diagnosed Parkinsonian patients that were randomly allocated to monotherapy with levodopa or a combination therapy based upon a nearly 40% replacement of levodopa by bromocriptine. The two target regimens had to be consistently maintained for 42 months. Parkinsonian symptoms were assessed by means of the Webster rating scale, the Hoehn and Yahr scale, and the Zung Self-Rating Depression scale. Motor side effects and adverse events were recorded at each regular clinic visit. Neurological symptoms improved and stabilized in a similar manner during treatment with both regimens throughout the study period. Motor side effects were observed in more patients on levodopa alone than on combination therapy (28.8 vs 20%; p=0.008). According to Kaplan-Meier estimates the cumulative probability of experiencing motor side effects was 0.43 on monotherapy, compared to 0.28 on combination therapy, which was equal to a one third reduction of risk (p=0.025). In regard to motor side effects, the degree of substitution of levodopa proved relevant: patients with >50% substitution by bromocriptine exhibited half the risk observed in those with <30% (p=0.045). The overall burden of motor side effects, as reflected by a sum score based upon the relevance, the severity and the extent of motor dysfunction, was also significantly less on combination therapy (p=0.046). In conclusion, partial substitution of levodopa by bromocriptine (>30%) as first-line treatment of Parkinson's disease proves active in the prophylaxis of levodopa associated motor side effects. Early combination therapy therefore extends the period of optimal disease control.</div></front></TEI><istex><corpusName>springer</corpusName><author><json:item><name>H. Przuntek</name><affiliations><json:string>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</json:string></affiliations></json:item><json:item><name>D. Welzel</name><affiliations><json:string>Institut für Pharmakologie, Universität Regensburg, Germany</json:string></affiliations></json:item><json:item><name>M. Gerlach</name><affiliations><json:string>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</json:string><json:string>Klinische Neurochemie, Universitäts-Nervenklinik, Würzburg</json:string></affiliations></json:item><json:item><name>E. Blümner</name><affiliations><json:string>Staticon, Medizinische Forschungsgesellschaft mbH, Planegg, Germany</json:string></affiliations></json:item><json:item><name>W. Danielczyk</name><affiliations><json:string>Neurologische Abteilung, Pflegeheim der Stadt Wien-Lainz, Ludwig-Boltzmann-Institut für Altersforschung, Vienna, Austria</json:string></affiliations></json:item><json:item><name>H. -J. Kaiser</name><affiliations><json:string>Sandoz AG, Nuremberg</json:string></affiliations></json:item><json:item><name>P. H. Kraus</name><affiliations><json:string>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</json:string></affiliations></json:item><json:item><name>H. Letzel</name><affiliations><json:string>Staticon, Medizinische Forschungsgesellschaft mbH, Planegg, Germany</json:string></affiliations></json:item><json:item><name>P. Riederer</name><affiliations><json:string>Klinische Neurochemie, Universitäts-Nervenklinik, Würzburg</json:string></affiliations></json:item><json:item><name>K. Überla</name><affiliations><json:string>Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Universität München, Germany</json:string></affiliations></json:item></author><articleId><json:string>Art6</json:string><json:string>BF01271230</json:string></articleId><language><json:string>eng</json:string></language><abstract>Summary: Long-term levodopa treatment in Parkinson's disease is typically associated with “motor side effects” consisting in dyskinesias and/or fluctuations in motility referred to as the on-off phenomena. The main objective of this prospective, randomized, multi-centre study was to determine to what extent the development of such complications could be prevented by partial substitution of levodopa monotherapy (L-DOPA/benserazide) by bromocriptine in patients with early symptoms of the disease. The basic trial population included 674 newly diagnosed Parkinsonian patients that were randomly allocated to monotherapy with levodopa or a combination therapy based upon a nearly 40% replacement of levodopa by bromocriptine. The two target regimens had to be consistently maintained for 42 months. Parkinsonian symptoms were assessed by means of the Webster rating scale, the Hoehn and Yahr scale, and the Zung Self-Rating Depression scale. Motor side effects and adverse events were recorded at each regular clinic visit. Neurological symptoms improved and stabilized in a similar manner during treatment with both regimens throughout the study period. Motor side effects were observed in more patients on levodopa alone than on combination therapy (28.8 vs 20%; p=0.008). According to Kaplan-Meier estimates the cumulative probability of experiencing motor side effects was 0.43 on monotherapy, compared to 0.28 on combination therapy, which was equal to a one third reduction of risk (p=0.025). In regard to motor side effects, the degree of substitution of levodopa proved relevant: patients with >50% substitution by bromocriptine exhibited half the risk observed in those with >30% (p=0.045). The overall burden of motor side effects, as reflected by a sum score based upon the relevance, the severity and the extent of motor dysfunction, was also significantly less on combination therapy (p=0.046). In conclusion, partial substitution of levodopa by bromocriptine (>30%) as first-line treatment of Parkinson's disease proves active in the prophylaxis of levodopa associated motor side effects. Early combination therapy therefore extends the period of optimal disease control.</abstract><qualityIndicators><score>8</score><pdfVersion>1.3</pdfVersion><pdfPageSize>576 x 774 pts</pdfPageSize><refBibsNative>false</refBibsNative><keywordCount>0</keywordCount><abstractCharCount>2186</abstractCharCount><pdfWordCount>6823</pdfWordCount><pdfCharCount>38348</pdfCharCount><pdfPageCount>17</pdfPageCount><abstractWordCount>316</abstractWordCount></qualityIndicators><title>Early institution of bromocriptine in Parkinson's disease inhibits the emergence of levodopa-associated motor side effects. Long-term results of the PRADO study</title><genre><json:string>research-article</json:string></genre><host><volume>103</volume><pages><last>715</last><first>699</first></pages><issn><json:string>0300-9564</json:string></issn><issue>6</issue><subject><json:item><value>Pharmacology/Toxicology</value></json:item><json:item><value>Neurology</value></json:item><json:item><value>Psychiatry</value></json:item></subject><journalId><json:string>702</json:string></journalId><genre><json:string>Journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1435-1463</json:string></eissn><title>Journal of Neural Transmission</title><publicationDate>1996</publicationDate><copyrightDate>1996</copyrightDate></host><publicationDate>1996</publicationDate><copyrightDate>1996</copyrightDate><doi><json:string>10.1007/BF01271230</json:string></doi><id>C1B49CBEEDEF204DF74573AD4429D84F056BF7FC</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/C1B49CBEEDEF204DF74573AD4429D84F056BF7FC/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/C1B49CBEEDEF204DF74573AD4429D84F056BF7FC/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/C1B49CBEEDEF204DF74573AD4429D84F056BF7FC/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Early institution of bromocriptine in Parkinson's disease inhibits the emergence of levodopa-associated motor side effects. Long-term results of the PRADO study</title><respStmt xml:id="ISTEX-API" resp="Références bibliographiques récupérées via GROBID" name="ISTEX-API (INIST-CNRS)"></respStmt></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Springer-Verlag</publisher><pubPlace>Vienna</pubPlace><availability><p>SPRINGER</p></availability><date>1995-05-25</date></publicationStmt><notesStmt><note>Dedicated to Dr. H. Bühlmann on the occasion of his 80th birthday</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Early institution of bromocriptine in Parkinson's disease inhibits the emergence of levodopa-associated motor side effects. Long-term results of the PRADO study</title><author><persName><forename type="first">H.</forename><surname>Przuntek</surname></persName><affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</affiliation></author><author><persName><forename type="first">D.</forename><surname>Welzel</surname></persName><affiliation>Institut für Pharmakologie, Universität Regensburg, Germany</affiliation></author><author><persName><forename type="first">M.</forename><surname>Gerlach</surname></persName><affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</affiliation><affiliation>Klinische Neurochemie, Universitäts-Nervenklinik, Würzburg</affiliation></author><author><persName><forename type="first">E.</forename><surname>Blümner</surname></persName><affiliation>Staticon, Medizinische Forschungsgesellschaft mbH, Planegg, Germany</affiliation></author><author><persName><forename type="first">W.</forename><surname>Danielczyk</surname></persName><affiliation>Neurologische Abteilung, Pflegeheim der Stadt Wien-Lainz, Ludwig-Boltzmann-Institut für Altersforschung, Vienna, Austria</affiliation></author><author><persName><forename type="first">H.</forename><surname>Kaiser</surname></persName><affiliation>Sandoz AG, Nuremberg</affiliation></author><author><persName><forename type="first">P.</forename><surname>Kraus</surname></persName><affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</affiliation></author><author><persName><forename type="first">H.</forename><surname>Letzel</surname></persName><affiliation>Staticon, Medizinische Forschungsgesellschaft mbH, Planegg, Germany</affiliation></author><author><persName><forename type="first">P.</forename><surname>Riederer</surname></persName><affiliation>Klinische Neurochemie, Universitäts-Nervenklinik, Würzburg</affiliation></author><author><persName><forename type="first">K.</forename><surname>Überla</surname></persName><affiliation>Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Universität München, Germany</affiliation></author></analytic><monogr><title level="j">Journal of Neural Transmission</title><title level="j" type="sub">Basic neurosciences and genetics, Parkinson's disease and allied conditions, Alzheimer's disease and related disorders, biological psychiatry</title><title level="j" type="abbrev">J. Neural Transmission</title><idno type="JournalID">702</idno><idno type="pISSN">0300-9564</idno><idno type="eISSN">1435-1463</idno><idno type="IssueArticleCount">12</idno><idno type="VolumeIssueCount">12</idno><imprint><publisher>Springer-Verlag</publisher><pubPlace>Vienna</pubPlace><date type="published" when="1996-06-01"></date><biblScope unit="volume">103</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="699">699</biblScope><biblScope unit="page" to="715">715</biblScope></imprint></monogr><idno type="istex">C1B49CBEEDEF204DF74573AD4429D84F056BF7FC</idno><idno type="DOI">10.1007/BF01271230</idno><idno type="ArticleID">Art6</idno><idno type="ArticleID">BF01271230</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>1995-05-25</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Summary: Long-term levodopa treatment in Parkinson's disease is typically associated with “motor side effects” consisting in dyskinesias and/or fluctuations in motility referred to as the on-off phenomena. The main objective of this prospective, randomized, multi-centre study was to determine to what extent the development of such complications could be prevented by partial substitution of levodopa monotherapy (L-DOPA/benserazide) by bromocriptine in patients with early symptoms of the disease. The basic trial population included 674 newly diagnosed Parkinsonian patients that were randomly allocated to monotherapy with levodopa or a combination therapy based upon a nearly 40% replacement of levodopa by bromocriptine. The two target regimens had to be consistently maintained for 42 months. Parkinsonian symptoms were assessed by means of the Webster rating scale, the Hoehn and Yahr scale, and the Zung Self-Rating Depression scale. Motor side effects and adverse events were recorded at each regular clinic visit. Neurological symptoms improved and stabilized in a similar manner during treatment with both regimens throughout the study period. Motor side effects were observed in more patients on levodopa alone than on combination therapy (28.8 vs 20%; p=0.008). According to Kaplan-Meier estimates the cumulative probability of experiencing motor side effects was 0.43 on monotherapy, compared to 0.28 on combination therapy, which was equal to a one third reduction of risk (p=0.025). In regard to motor side effects, the degree of substitution of levodopa proved relevant: patients with >50% substitution by bromocriptine exhibited half the risk observed in those with <30% (p=0.045). The overall burden of motor side effects, as reflected by a sum score based upon the relevance, the severity and the extent of motor dysfunction, was also significantly less on combination therapy (p=0.046). In conclusion, partial substitution of levodopa by bromocriptine (>30%) as first-line treatment of Parkinson's disease proves active in the prophylaxis of levodopa associated motor side effects. Early combination therapy therefore extends the period of optimal disease control.</p></abstract><textClass><keywords scheme="Journal Subject"><list><head>Medicine & Public Health</head><item><term>Pharmacology/Toxicology</term></item><item><term>Neurology</term></item><item><term>Psychiatry</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="1995-05-25">Created</change><change when="1996-06-01">Published</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2016-3-2">References added</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/C1B49CBEEDEF204DF74573AD4429D84F056BF7FC/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Springer, Publisher found" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//Springer-Verlag//DTD A++ V2.4//EN" URI="http://devel.springer.de/A++/V2.4/DTD/A++V2.4.dtd" name="istex:docType"></istex:docType><istex:document><Publisher><PublisherInfo><PublisherName>Springer-Verlag</PublisherName><PublisherLocation>Vienna</PublisherLocation></PublisherInfo><Journal><JournalInfo JournalProductType="ArchiveJournal" NumberingStyle="Unnumbered"><JournalID>702</JournalID><JournalPrintISSN>0300-9564</JournalPrintISSN><JournalElectronicISSN>1435-1463</JournalElectronicISSN><JournalTitle>Journal of Neural Transmission</JournalTitle><JournalSubTitle>Basic neurosciences and genetics, Parkinson's disease and allied conditions, Alzheimer's disease and related disorders, biological psychiatry</JournalSubTitle><JournalAbbreviatedTitle>J. Neural Transmission</JournalAbbreviatedTitle><JournalSubjectGroup><JournalSubject Type="Primary">Medicine & Public Health</JournalSubject><JournalSubject Type="Secondary">Pharmacology/Toxicology</JournalSubject><JournalSubject Type="Secondary">Neurology</JournalSubject><JournalSubject Type="Secondary">Psychiatry</JournalSubject></JournalSubjectGroup></JournalInfo><Volume><VolumeInfo VolumeType="Regular" TocLevels="0"><VolumeIDStart>103</VolumeIDStart><VolumeIDEnd>103</VolumeIDEnd><VolumeIssueCount>12</VolumeIssueCount></VolumeInfo><Issue IssueType="Regular"><IssueInfo TocLevels="0"><IssueIDStart>6</IssueIDStart><IssueIDEnd>6</IssueIDEnd><IssueArticleCount>12</IssueArticleCount><IssueHistory><CoverDate><DateString>1996</DateString><Year>1996</Year><Month>6</Month></CoverDate></IssueHistory><IssueCopyright><CopyrightHolderName>Springer-Verlag</CopyrightHolderName><CopyrightYear>1996</CopyrightYear></IssueCopyright></IssueInfo><Article ID="Art6"><ArticleInfo Language="En" ArticleType="OriginalPaper" NumberingStyle="Unnumbered" TocLevels="0" ContainsESM="No"><ArticleID>BF01271230</ArticleID><ArticleDOI>10.1007/BF01271230</ArticleDOI><ArticleSequenceNumber>6</ArticleSequenceNumber><ArticleTitle Language="En">Early institution of bromocriptine in Parkinson's disease inhibits the emergence of levodopa-associated motor side effects. Long-term results of the PRADO study</ArticleTitle><ArticleSubCategory>Parkinson's Disease and Allied Conditions</ArticleSubCategory><ArticleFirstPage>699</ArticleFirstPage><ArticleLastPage>715</ArticleLastPage><ArticleHistory><RegistrationDate><Year>2005</Year><Month>2</Month><Day>21</Day></RegistrationDate><Received><Year>1995</Year><Month>5</Month><Day>25</Day></Received><Accepted><Year>1996</Year><Month>3</Month><Day>4</Day></Accepted></ArticleHistory><ArticleCopyright><CopyrightHolderName>Springer-Verlag</CopyrightHolderName><CopyrightYear>1996</CopyrightYear></ArticleCopyright><ArticleGrants Type="Regular"><MetadataGrant Grant="OpenAccess"></MetadataGrant><AbstractGrant Grant="OpenAccess"></AbstractGrant><BodyPDFGrant Grant="Restricted"></BodyPDFGrant><BodyHTMLGrant Grant="Restricted"></BodyHTMLGrant><BibliographyGrant Grant="Restricted"></BibliographyGrant><ESMGrant Grant="Restricted"></ESMGrant></ArticleGrants><ArticleContext><JournalID>702</JournalID><VolumeIDStart>103</VolumeIDStart><VolumeIDEnd>103</VolumeIDEnd><IssueIDStart>6</IssueIDStart><IssueIDEnd>6</IssueIDEnd></ArticleContext></ArticleInfo><ArticleHeader><AuthorGroup><Author AffiliationIDS="Aff1" PresentAffiliationID="Aff1"><AuthorName DisplayOrder="Western"><GivenName>H.</GivenName><FamilyName>Przuntek</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff2"><AuthorName DisplayOrder="Western"><GivenName>D.</GivenName><FamilyName>Welzel</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff1 Aff3"><AuthorName DisplayOrder="Western"><GivenName>M.</GivenName><FamilyName>Gerlach</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff4"><AuthorName DisplayOrder="Western"><GivenName>E.</GivenName><FamilyName>Blümner</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff5"><AuthorName DisplayOrder="Western"><GivenName>W.</GivenName><FamilyName>Danielczyk</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff6"><AuthorName DisplayOrder="Western"><GivenName>H.</GivenName><GivenName>-J.</GivenName><FamilyName>Kaiser</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff1"><AuthorName DisplayOrder="Western"><GivenName>P.</GivenName><GivenName>H.</GivenName><FamilyName>Kraus</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff4"><AuthorName DisplayOrder="Western"><GivenName>H.</GivenName><FamilyName>Letzel</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff3"><AuthorName DisplayOrder="Western"><GivenName>P.</GivenName><FamilyName>Riederer</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff7"><AuthorName DisplayOrder="Western"><GivenName>K.</GivenName><FamilyName>Überla</FamilyName></AuthorName></Author><Affiliation ID="Aff1"><OrgDivision>Neurologische Klinik</OrgDivision><OrgName>Ruhr-Universität, St. Josef-Hospital</OrgName><OrgAddress><City>Bochum</City></OrgAddress></Affiliation><Affiliation ID="Aff2"><OrgDivision>Institut für Pharmakologie</OrgDivision><OrgName>Universität Regensburg</OrgName><OrgAddress><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff6"><OrgName>Sandoz AG</OrgName><OrgAddress><City>Nuremberg</City></OrgAddress></Affiliation><Affiliation ID="Aff3"><OrgDivision>Klinische Neurochemie</OrgDivision><OrgName>Universitäts-Nervenklinik</OrgName><OrgAddress><City>Würzburg</City></OrgAddress></Affiliation><Affiliation ID="Aff4"><OrgName>Staticon, Medizinische Forschungsgesellschaft mbH</OrgName><OrgAddress><City>Planegg</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff5"><OrgDivision>Neurologische Abteilung</OrgDivision><OrgName>Pflegeheim der Stadt Wien-Lainz, Ludwig-Boltzmann-Institut für Altersforschung</OrgName><OrgAddress><City>Vienna</City><Country>Austria</Country></OrgAddress></Affiliation><Affiliation ID="Aff7"><OrgDivision>Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie</OrgDivision><OrgName>Universität München</OrgName><OrgAddress><Country>Germany</Country></OrgAddress></Affiliation></AuthorGroup><Abstract ID="Abs1" Language="En"><Heading>Summary</Heading><Para>Long-term levodopa treatment in Parkinson's disease is typically associated with “motor side effects” consisting in dyskinesias and/or fluctuations in motility referred to as the on-off phenomena. The main objective of this prospective, randomized, multi-centre study was to determine to what extent the development of such complications could be prevented by partial substitution of levodopa monotherapy (L-DOPA/benserazide) by bromocriptine in patients with early symptoms of the disease. The basic trial population included 674 newly diagnosed Parkinsonian patients that were randomly allocated to monotherapy with levodopa or a combination therapy based upon a nearly 40% replacement of levodopa by bromocriptine. The two target regimens had to be consistently maintained for 42 months. Parkinsonian symptoms were assessed by means of the Webster rating scale, the Hoehn and Yahr scale, and the Zung Self-Rating Depression scale. Motor side effects and adverse events were recorded at each regular clinic visit.</Para><Para>Neurological symptoms improved and stabilized in a similar manner during treatment with both regimens throughout the study period. Motor side effects were observed in more patients on levodopa alone than on combination therapy (28.8 vs 20%; p=0.008). According to Kaplan-Meier estimates the cumulative probability of experiencing motor side effects was 0.43 on monotherapy, compared to 0.28 on combination therapy, which was equal to a one third reduction of risk (p=0.025). In regard to motor side effects, the degree of substitution of levodopa proved relevant: patients with >50% substitution by bromocriptine exhibited half the risk observed in those with <30% (p=0.045). The overall burden of motor side effects, as reflected by a sum score based upon the relevance, the severity and the extent of motor dysfunction, was also significantly less on combination therapy (p=0.046).</Para><Para>In conclusion, partial substitution of levodopa by bromocriptine (>30%) as first-line treatment of Parkinson's disease proves active in the prophylaxis of levodopa associated motor side effects. Early combination therapy therefore extends the period of optimal disease control.</Para></Abstract><KeywordGroup Language="En"><Heading>Keywords</Heading><Keyword>Parkinson's disease</Keyword><Keyword>bromocriptine</Keyword><Keyword>L-DOPA</Keyword><Keyword>levodopa</Keyword><Keyword>motor fluctuations</Keyword><Keyword>adverse effects</Keyword><Keyword>early combination therapy</Keyword><Keyword>long-term treatment</Keyword></KeywordGroup><ArticleNote Type="Dedication"><SimplePara>Dedicated to Dr. H. Bühlmann on the occasion of his 80th birthday</SimplePara></ArticleNote></ArticleHeader><NoBody></NoBody></Article></Issue></Volume></Journal></Publisher></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Early institution of bromocriptine in Parkinson's disease inhibits the emergence of levodopa-associated motor side effects. Long-term results of the PRADO study</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Early institution of bromocriptine in Parkinson's disease inhibits the emergence of levodopa-associated motor side effects. Long-term results of the PRADO study</title></titleInfo><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Przuntek</namePart><affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Welzel</namePart><affiliation>Institut für Pharmakologie, Universität Regensburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Gerlach</namePart><affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</affiliation><affiliation>Klinische Neurochemie, Universitäts-Nervenklinik, Würzburg</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E.</namePart><namePart type="family">Blümner</namePart><affiliation>Staticon, Medizinische Forschungsgesellschaft mbH, Planegg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Danielczyk</namePart><affiliation>Neurologische Abteilung, Pflegeheim der Stadt Wien-Lainz, Ludwig-Boltzmann-Institut für Altersforschung, Vienna, Austria</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="given">-J.</namePart><namePart type="family">Kaiser</namePart><affiliation>Sandoz AG, Nuremberg</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="given">H.</namePart><namePart type="family">Kraus</namePart><affiliation>Neurologische Klinik, Ruhr-Universität, St. Josef-Hospital, Bochum</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Letzel</namePart><affiliation>Staticon, Medizinische Forschungsgesellschaft mbH, Planegg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="family">Riederer</namePart><affiliation>Klinische Neurochemie, Universitäts-Nervenklinik, Würzburg</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K.</namePart><namePart type="family">Überla</namePart><affiliation>Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Universität München, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="OriginalPaper"></genre><originInfo><publisher>Springer-Verlag</publisher><place><placeTerm type="text">Vienna</placeTerm></place><dateCreated encoding="w3cdtf">1995-05-25</dateCreated><dateIssued encoding="w3cdtf">1996-06-01</dateIssued><copyrightDate encoding="w3cdtf">1996</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">Summary: Long-term levodopa treatment in Parkinson's disease is typically associated with “motor side effects” consisting in dyskinesias and/or fluctuations in motility referred to as the on-off phenomena. The main objective of this prospective, randomized, multi-centre study was to determine to what extent the development of such complications could be prevented by partial substitution of levodopa monotherapy (L-DOPA/benserazide) by bromocriptine in patients with early symptoms of the disease. The basic trial population included 674 newly diagnosed Parkinsonian patients that were randomly allocated to monotherapy with levodopa or a combination therapy based upon a nearly 40% replacement of levodopa by bromocriptine. The two target regimens had to be consistently maintained for 42 months. Parkinsonian symptoms were assessed by means of the Webster rating scale, the Hoehn and Yahr scale, and the Zung Self-Rating Depression scale. Motor side effects and adverse events were recorded at each regular clinic visit. Neurological symptoms improved and stabilized in a similar manner during treatment with both regimens throughout the study period. Motor side effects were observed in more patients on levodopa alone than on combination therapy (28.8 vs 20%; p=0.008). According to Kaplan-Meier estimates the cumulative probability of experiencing motor side effects was 0.43 on monotherapy, compared to 0.28 on combination therapy, which was equal to a one third reduction of risk (p=0.025). In regard to motor side effects, the degree of substitution of levodopa proved relevant: patients with >50% substitution by bromocriptine exhibited half the risk observed in those with <30% (p=0.045). The overall burden of motor side effects, as reflected by a sum score based upon the relevance, the severity and the extent of motor dysfunction, was also significantly less on combination therapy (p=0.046). In conclusion, partial substitution of levodopa by bromocriptine (>30%) as first-line treatment of Parkinson's disease proves active in the prophylaxis of levodopa associated motor side effects. Early combination therapy therefore extends the period of optimal disease control.</abstract><note>Dedicated to Dr. H. Bühlmann on the occasion of his 80th birthday</note><relatedItem type="host"><titleInfo><title>Journal of Neural Transmission</title><subTitle>Basic neurosciences and genetics, Parkinson's disease and allied conditions, Alzheimer's disease and related disorders, biological psychiatry</subTitle></titleInfo><titleInfo type="abbreviated"><title>J. 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