The long-term safety and efficacy of pramipexole in advanced Parkinson's disease
Identifieur interne : 002564 ( Main/Corpus ); précédent : 002563; suivant : 002565The long-term safety and efficacy of pramipexole in advanced Parkinson's disease
Auteurs : W. J Weiner ; S. A Factor ; J. Jankovic ; R. A Hauser ; J. W Tetrud ; C. H Waters ; L. M Shulman ; P. M Glassman ; B. Beck ; D. Paume ; C. DoyleSource :
- Parkinsonism and Related Disorders [ 1353-8020 ] ; 2000.
English descriptors
- KwdEn :
Abstract
Objective: To assess the long-term safety and efficacy of pramipexole in advanced Parkinson's disease over a four year time period. Methods: This study is an open-label extension trial of pramipexole for Parkinson's disease open to patients completing a double-blind placebo controlled safety and efficacy trial of this drug. Three hundred and six patients entered the trial. These patients had moderate to severe PD (stage II–IV Hoehn and Yahr during off time) and were experiencing motor fluctuations. Patients were titrated over a six week period and then entered a maintenance phase which lasted up to 50 months. Patients were evaluated every 3 months using the Unified Parkinson's Disease Rating Scale (UPDRS II, III and IV) and modified Schwab and England scale (S/E). Results: Sixty-four percent (197) of the 306 patients who entered this study completed it. Patients showed steady improvement over the 6 week ascending dose interval when pramipexole was reintroduced into the trial as the open-label study medication. Over the duration of the trial patients slowly returned to their baseline levels. This was true for all measures evaluated except for the UPDRS part IV. On UPDRS part IV patients remained below their baseline score which indicated an improvement for the duration of the study. Patterns similar to the overall scores were seen when the individual components of the UPDRS scale part II for “on” and “off” periods and part III were evaluated. However tremor during “on” periods showed improvement over baseline for the duration of the trial. The most common adverse events secondary to pramipexole occurring in greater than 10% of patients included dyskinesias, asymptomatic orthostatic hypotension, dizziness, insomnia, and hallucinations. Conclusion: Pramipexole was well tolerated for up to 4 years. Pramipexole treatment appeared to show continued efficacy in the treatment of Parkinson's disease for 3 years in this open-label descriptive study. After 3 years there was a gradual return to baseline motor states perhaps suggesting progression of Parkinson's disease.
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DOI: 10.1016/S1353-8020(00)00031-6
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Jankovic</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Hauser, R A" sort="Hauser, R A" uniqKey="Hauser R" first="R. A" last="Hauser">R. A Hauser</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Tetrud, J W" sort="Tetrud, J W" uniqKey="Tetrud J" first="J. W" last="Tetrud">J. W Tetrud</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Waters, C H" sort="Waters, C H" uniqKey="Waters C" first="C. H" last="Waters">C. H Waters</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Shulman, L M" sort="Shulman, L M" uniqKey="Shulman L" first="L. M" last="Shulman">L. M Shulman</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Glassman, P M" sort="Glassman, P M" uniqKey="Glassman P" first="P. M" last="Glassman">P. M Glassman</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Beck, B" sort="Beck, B" uniqKey="Beck B" first="B" last="Beck">B. Beck</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Paume, D" sort="Paume, D" uniqKey="Paume D" first="D" last="Paume">D. Paume</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Doyle, C" sort="Doyle, C" uniqKey="Doyle C" first="C" last="Doyle">C. 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J Weiner</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Factor, S A" sort="Factor, S A" uniqKey="Factor S" first="S. A" last="Factor">S. A Factor</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Jankovic, J" sort="Jankovic, J" uniqKey="Jankovic J" first="J" last="Jankovic">J. Jankovic</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Hauser, R A" sort="Hauser, R A" uniqKey="Hauser R" first="R. A" last="Hauser">R. A Hauser</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Tetrud, J W" sort="Tetrud, J W" uniqKey="Tetrud J" first="J. W" last="Tetrud">J. W Tetrud</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Waters, C H" sort="Waters, C H" uniqKey="Waters C" first="C. H" last="Waters">C. H Waters</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Shulman, L M" sort="Shulman, L M" uniqKey="Shulman L" first="L. M" last="Shulman">L. M Shulman</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Glassman, P M" sort="Glassman, P M" uniqKey="Glassman P" first="P. M" last="Glassman">P. M Glassman</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Beck, B" sort="Beck, B" uniqKey="Beck B" first="B" last="Beck">B. Beck</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Paume, D" sort="Paume, D" uniqKey="Paume D" first="D" last="Paume">D. Paume</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author><author><name sortKey="Doyle, C" sort="Doyle, C" uniqKey="Doyle C" first="C" last="Doyle">C. Doyle</name><affiliation><mods:affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Parkinsonism and Related Disorders</title><title level="j" type="abbrev">PRD</title><idno type="ISSN">1353-8020</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="2000">2000</date><biblScope unit="volume">7</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="115">115</biblScope><biblScope unit="page" to="120">120</biblScope></imprint><idno type="ISSN">1353-8020</idno></series><idno type="istex">0842CF509A52EE9F6DB421C407B58B6A123DA80F</idno><idno type="DOI">10.1016/S1353-8020(00)00031-6</idno><idno type="PII">S1353-8020(00)00031-6</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1353-8020</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Efficacy</term><term>Parkinson's disease</term><term>Pramipexole</term><term>Safety</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objective: To assess the long-term safety and efficacy of pramipexole in advanced Parkinson's disease over a four year time period. Methods: This study is an open-label extension trial of pramipexole for Parkinson's disease open to patients completing a double-blind placebo controlled safety and efficacy trial of this drug. Three hundred and six patients entered the trial. These patients had moderate to severe PD (stage II–IV Hoehn and Yahr during off time) and were experiencing motor fluctuations. Patients were titrated over a six week period and then entered a maintenance phase which lasted up to 50 months. Patients were evaluated every 3 months using the Unified Parkinson's Disease Rating Scale (UPDRS II, III and IV) and modified Schwab and England scale (S/E). Results: Sixty-four percent (197) of the 306 patients who entered this study completed it. Patients showed steady improvement over the 6 week ascending dose interval when pramipexole was reintroduced into the trial as the open-label study medication. Over the duration of the trial patients slowly returned to their baseline levels. This was true for all measures evaluated except for the UPDRS part IV. On UPDRS part IV patients remained below their baseline score which indicated an improvement for the duration of the study. Patterns similar to the overall scores were seen when the individual components of the UPDRS scale part II for “on” and “off” periods and part III were evaluated. However tremor during “on” periods showed improvement over baseline for the duration of the trial. The most common adverse events secondary to pramipexole occurring in greater than 10% of patients included dyskinesias, asymptomatic orthostatic hypotension, dizziness, insomnia, and hallucinations. Conclusion: Pramipexole was well tolerated for up to 4 years. Pramipexole treatment appeared to show continued efficacy in the treatment of Parkinson's disease for 3 years in this open-label descriptive study. After 3 years there was a gradual return to baseline motor states perhaps suggesting progression of Parkinson's disease.</div></front></TEI><istex><corpusName>elsevier</corpusName><author><json:item><name>W.J Weiner</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item><json:item><name>S.A Factor</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item><json:item><name>J Jankovic</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item><json:item><name>R.A Hauser</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item><json:item><name>J.W Tetrud</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item><json:item><name>C.H Waters</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item><json:item><name>L.M Shulman</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item><json:item><name>P.M Glassman</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item><json:item><name>B Beck</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item><json:item><name>D Paume</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item><json:item><name>C Doyle</name><affiliations><json:string>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</json:string></affiliations></json:item></author><subject><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>Pramipexole</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Safety</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Efficacy</value></json:item></subject><language><json:string>eng</json:string></language><abstract>Objective: To assess the long-term safety and efficacy of pramipexole in advanced Parkinson's disease over a four year time period. Methods: This study is an open-label extension trial of pramipexole for Parkinson's disease open to patients completing a double-blind placebo controlled safety and efficacy trial of this drug. Three hundred and six patients entered the trial. These patients had moderate to severe PD (stage II–IV Hoehn and Yahr during off time) and were experiencing motor fluctuations. Patients were titrated over a six week period and then entered a maintenance phase which lasted up to 50 months. Patients were evaluated every 3 months using the Unified Parkinson's Disease Rating Scale (UPDRS II, III and IV) and modified Schwab and England scale (S/E). Results: Sixty-four percent (197) of the 306 patients who entered this study completed it. Patients showed steady improvement over the 6 week ascending dose interval when pramipexole was reintroduced into the trial as the open-label study medication. Over the duration of the trial patients slowly returned to their baseline levels. This was true for all measures evaluated except for the UPDRS part IV. On UPDRS part IV patients remained below their baseline score which indicated an improvement for the duration of the study. Patterns similar to the overall scores were seen when the individual components of the UPDRS scale part II for “on” and “off” periods and part III were evaluated. However tremor during “on” periods showed improvement over baseline for the duration of the trial. The most common adverse events secondary to pramipexole occurring in greater than 10% of patients included dyskinesias, asymptomatic orthostatic hypotension, dizziness, insomnia, and hallucinations. Conclusion: Pramipexole was well tolerated for up to 4 years. Pramipexole treatment appeared to show continued efficacy in the treatment of Parkinson's disease for 3 years in this open-label descriptive study. After 3 years there was a gradual return to baseline motor states perhaps suggesting progression of Parkinson's disease.</abstract><qualityIndicators><score>6.008</score><pdfVersion>1.2</pdfVersion><pdfPageSize>595 x 794 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>4</keywordCount><abstractCharCount>2094</abstractCharCount><pdfWordCount>3008</pdfWordCount><pdfCharCount>20208</pdfCharCount><pdfPageCount>6</pdfPageCount><abstractWordCount>320</abstractWordCount></qualityIndicators><title>The long-term safety and efficacy of pramipexole in advanced Parkinson's disease</title><pii><json:string>S1353-8020(00)00031-6</json:string></pii><genre><json:string>research-article</json:string></genre><host><volume>7</volume><pii><json:string>S1353-8020(00)X0024-7</json:string></pii><pages><last>120</last><first>115</first></pages><issn><json:string>1353-8020</json:string></issn><issue>2</issue><genre><json:string>Journal</json:string></genre><language><json:string>unknown</json:string></language><title>Parkinsonism and Related Disorders</title><publicationDate>2001</publicationDate></host><categories><wos><json:string>CLINICAL NEUROLOGY</json:string></wos></categories><publicationDate>2000</publicationDate><copyrightDate>2001</copyrightDate><doi><json:string>10.1016/S1353-8020(00)00031-6</json:string></doi><id>0842CF509A52EE9F6DB421C407B58B6A123DA80F</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/0842CF509A52EE9F6DB421C407B58B6A123DA80F/fulltext/pdf</uri></json:item><json:item><original>true</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/0842CF509A52EE9F6DB421C407B58B6A123DA80F/fulltext/txt</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/0842CF509A52EE9F6DB421C407B58B6A123DA80F/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/0842CF509A52EE9F6DB421C407B58B6A123DA80F/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">The long-term safety and efficacy of pramipexole in advanced Parkinson's disease</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>ELSEVIER</publisher><availability><p>ELSEVIER</p></availability><date>2001</date></publicationStmt><notesStmt><note type="content">Table 1: Baseline demographics</note><note type="content">Table 2: Baseline PD characteristics at entry</note><note type="content">Table 3: Overall most common (≥10%) adverse events in all patients related to pramipexole</note><note type="content">Table 4: Percent prevalence of adverse events over the duration of treatment</note><note type="content">Table 5: Efficacy endpoints (improvement in UPDRS scores from baseline is indicated by negative numbers; improvement in Schwab and England scale is indicated by positive numbers; and #refers to protocol visit number)</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">The long-term safety and efficacy of pramipexole in advanced Parkinson's disease</title><author><persName><forename type="first">W.J</forename><surname>Weiner</surname></persName><note type="correspondence"><p>Corresponding author. Tel.: +1-305-243-6332; fax: +1-305-243-4678</p></note><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author><author><persName><forename type="first">S.A</forename><surname>Factor</surname></persName><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author><author><persName><forename type="first">J</forename><surname>Jankovic</surname></persName><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author><author><persName><forename type="first">R.A</forename><surname>Hauser</surname></persName><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author><author><persName><forename type="first">J.W</forename><surname>Tetrud</surname></persName><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author><author><persName><forename type="first">C.H</forename><surname>Waters</surname></persName><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author><author><persName><forename type="first">L.M</forename><surname>Shulman</surname></persName><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author><author><persName><forename type="first">P.M</forename><surname>Glassman</surname></persName><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author><author><persName><forename type="first">B</forename><surname>Beck</surname></persName><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author><author><persName><forename type="first">D</forename><surname>Paume</surname></persName><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author><author><persName><forename type="first">C</forename><surname>Doyle</surname></persName><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation></author></analytic><monogr><title level="j">Parkinsonism and Related Disorders</title><title level="j" type="abbrev">PRD</title><idno type="pISSN">1353-8020</idno><idno type="PII">S1353-8020(00)X0024-7</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="2000"></date><biblScope unit="volume">7</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="115">115</biblScope><biblScope unit="page" to="120">120</biblScope></imprint></monogr><idno type="istex">0842CF509A52EE9F6DB421C407B58B6A123DA80F</idno><idno type="DOI">10.1016/S1353-8020(00)00031-6</idno><idno type="PII">S1353-8020(00)00031-6</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2001</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Objective: To assess the long-term safety and efficacy of pramipexole in advanced Parkinson's disease over a four year time period. Methods: This study is an open-label extension trial of pramipexole for Parkinson's disease open to patients completing a double-blind placebo controlled safety and efficacy trial of this drug. Three hundred and six patients entered the trial. These patients had moderate to severe PD (stage II–IV Hoehn and Yahr during off time) and were experiencing motor fluctuations. Patients were titrated over a six week period and then entered a maintenance phase which lasted up to 50 months. Patients were evaluated every 3 months using the Unified Parkinson's Disease Rating Scale (UPDRS II, III and IV) and modified Schwab and England scale (S/E). Results: Sixty-four percent (197) of the 306 patients who entered this study completed it. Patients showed steady improvement over the 6 week ascending dose interval when pramipexole was reintroduced into the trial as the open-label study medication. Over the duration of the trial patients slowly returned to their baseline levels. This was true for all measures evaluated except for the UPDRS part IV. On UPDRS part IV patients remained below their baseline score which indicated an improvement for the duration of the study. Patterns similar to the overall scores were seen when the individual components of the UPDRS scale part II for “on” and “off” periods and part III were evaluated. However tremor during “on” periods showed improvement over baseline for the duration of the trial. The most common adverse events secondary to pramipexole occurring in greater than 10% of patients included dyskinesias, asymptomatic orthostatic hypotension, dizziness, insomnia, and hallucinations. Conclusion: Pramipexole was well tolerated for up to 4 years. Pramipexole treatment appeared to show continued efficacy in the treatment of Parkinson's disease for 3 years in this open-label descriptive study. After 3 years there was a gradual return to baseline motor states perhaps suggesting progression of Parkinson's disease.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Parkinson's disease</term></item><item><term>Pramipexole</term></item><item><term>Safety</term></item><item><term>Efficacy</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2000-05-29">Registration</change><change when="2000-03-17">Modified</change><change when="2000">Published</change></revisionDesc></teiHeader></istex:fulltextTEI></fulltext><metadata><istex:metadataXml wicri:clean="Elsevier, elements deleted: ce:floats; body; tail"><istex:xmlDeclaration>version="1.0" encoding="utf-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//ES//DTD journal article DTD version 4.5.2//EN//XML" URI="art452.dtd" name="istex:docType"></istex:docType><istex:document><converted-article version="4.5.2" docsubtype="fla" xml:lang="en"><item-info><jid>PRD</jid><aid>224</aid><ce:pii>S1353-8020(00)00031-6</ce:pii><ce:doi>10.1016/S1353-8020(00)00031-6</ce:doi><ce:copyright type="full-transfer" year="2001">Elsevier Science Ltd</ce:copyright></item-info><head><ce:title>The long-term safety and efficacy of pramipexole in advanced Parkinson's disease</ce:title><ce:author-group><ce:author><ce:given-name>W.J</ce:given-name><ce:surname>Weiner</ce:surname><ce:cross-ref refid="CORR1">*</ce:cross-ref></ce:author><ce:author><ce:given-name>S.A</ce:given-name><ce:surname>Factor</ce:surname></ce:author><ce:author><ce:given-name>J</ce:given-name><ce:surname>Jankovic</ce:surname></ce:author><ce:author><ce:given-name>R.A</ce:given-name><ce:surname>Hauser</ce:surname></ce:author><ce:author><ce:given-name>J.W</ce:given-name><ce:surname>Tetrud</ce:surname></ce:author><ce:author><ce:given-name>C.H</ce:given-name><ce:surname>Waters</ce:surname></ce:author><ce:author><ce:given-name>L.M</ce:given-name><ce:surname>Shulman</ce:surname></ce:author><ce:author><ce:given-name>P.M</ce:given-name><ce:surname>Glassman</ce:surname></ce:author><ce:author><ce:given-name>B</ce:given-name><ce:surname>Beck</ce:surname></ce:author><ce:author><ce:given-name>D</ce:given-name><ce:surname>Paume</ce:surname></ce:author><ce:author><ce:given-name>C</ce:given-name><ce:surname>Doyle</ce:surname></ce:author><ce:affiliation><ce:textfn>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</ce:textfn></ce:affiliation><ce:correspondence id="CORR1"><ce:label>*</ce:label><ce:text>Corresponding author. Tel.: +1-305-243-6332; fax: +1-305-243-4678</ce:text></ce:correspondence></ce:author-group><ce:date-received day="17" month="3" year="2000"></ce:date-received><ce:date-revised day="17" month="3" year="2000"></ce:date-revised><ce:date-accepted day="29" month="5" year="2000"></ce:date-accepted><ce:abstract><ce:section-title>Abstract</ce:section-title><ce:abstract-sec><ce:simple-para><ce:italic>Objective:</ce:italic> To assess the long-term safety and efficacy of pramipexole in advanced Parkinson's disease over a four year time period.</ce:simple-para><ce:simple-para><ce:italic>Methods:</ce:italic> This study is an open-label extension trial of pramipexole for Parkinson's disease open to patients completing a double-blind placebo controlled safety and efficacy trial of this drug. Three hundred and six patients entered the trial. These patients had moderate to severe PD (stage II–IV Hoehn and Yahr during off time) and were experiencing motor fluctuations. Patients were titrated over a six week period and then entered a maintenance phase which lasted up to 50 months. Patients were evaluated every 3 months using the Unified Parkinson's Disease Rating Scale (UPDRS II, III and IV) and modified Schwab and England scale (S/E).</ce:simple-para><ce:simple-para><ce:italic>Results:</ce:italic> Sixty-four percent (197) of the 306 patients who entered this study completed it. Patients showed steady improvement over the 6 week ascending dose interval when pramipexole was reintroduced into the trial as the open-label study medication. Over the duration of the trial patients slowly returned to their baseline levels. This was true for all measures evaluated except for the UPDRS part IV. On UPDRS part IV patients remained below their baseline score which indicated an improvement for the duration of the study. Patterns similar to the overall scores were seen when the individual components of the UPDRS scale part II for “on” and “off” periods and part III were evaluated. However tremor during “on” periods showed improvement over baseline for the duration of the trial. The most common adverse events secondary to pramipexole occurring in greater than 10% of patients included dyskinesias, asymptomatic orthostatic hypotension, dizziness, insomnia, and hallucinations.</ce:simple-para><ce:simple-para><ce:italic>Conclusion:</ce:italic> Pramipexole was well tolerated for up to 4 years. Pramipexole treatment appeared to show continued efficacy in the treatment of Parkinson's disease for 3 years in this open-label descriptive study. After 3 years there was a gradual return to baseline motor states perhaps suggesting progression of Parkinson's disease.</ce:simple-para></ce:abstract-sec></ce:abstract><ce:keywords class="keyword" xml:lang="en"><ce:section-title>Keywords</ce:section-title><ce:keyword><ce:text>Parkinson's disease</ce:text></ce:keyword><ce:keyword><ce:text>Pramipexole</ce:text></ce:keyword><ce:keyword><ce:text>Safety</ce:text></ce:keyword><ce:keyword><ce:text>Efficacy</ce:text></ce:keyword></ce:keywords></head></converted-article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>The long-term safety and efficacy of pramipexole in advanced Parkinson's disease</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>The long-term safety and efficacy of pramipexole in advanced Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">W.J</namePart><namePart type="family">Weiner</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><description>Corresponding author. Tel.: +1-305-243-6332; fax: +1-305-243-4678</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.A</namePart><namePart type="family">Factor</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J</namePart><namePart type="family">Jankovic</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.A</namePart><namePart type="family">Hauser</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.W</namePart><namePart type="family">Tetrud</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.H</namePart><namePart type="family">Waters</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">L.M</namePart><namePart type="family">Shulman</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.M</namePart><namePart type="family">Glassman</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B</namePart><namePart type="family">Beck</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D</namePart><namePart type="family">Paume</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C</namePart><namePart type="family">Doyle</namePart><affiliation>Department of Neurology, University of Miami School of Medicine, 1501 N.W. 9 Avenue, Miami, FL 33136, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="Full-length article"></genre><originInfo><publisher>ELSEVIER</publisher><dateIssued encoding="w3cdtf">2000</dateIssued><dateValid encoding="w3cdtf">2000-05-29</dateValid><dateModified encoding="w3cdtf">2000-03-17</dateModified><copyrightDate encoding="w3cdtf">2001</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">Objective: To assess the long-term safety and efficacy of pramipexole in advanced Parkinson's disease over a four year time period. Methods: This study is an open-label extension trial of pramipexole for Parkinson's disease open to patients completing a double-blind placebo controlled safety and efficacy trial of this drug. Three hundred and six patients entered the trial. These patients had moderate to severe PD (stage II–IV Hoehn and Yahr during off time) and were experiencing motor fluctuations. Patients were titrated over a six week period and then entered a maintenance phase which lasted up to 50 months. Patients were evaluated every 3 months using the Unified Parkinson's Disease Rating Scale (UPDRS II, III and IV) and modified Schwab and England scale (S/E). Results: Sixty-four percent (197) of the 306 patients who entered this study completed it. Patients showed steady improvement over the 6 week ascending dose interval when pramipexole was reintroduced into the trial as the open-label study medication. Over the duration of the trial patients slowly returned to their baseline levels. This was true for all measures evaluated except for the UPDRS part IV. On UPDRS part IV patients remained below their baseline score which indicated an improvement for the duration of the study. Patterns similar to the overall scores were seen when the individual components of the UPDRS scale part II for “on” and “off” periods and part III were evaluated. However tremor during “on” periods showed improvement over baseline for the duration of the trial. The most common adverse events secondary to pramipexole occurring in greater than 10% of patients included dyskinesias, asymptomatic orthostatic hypotension, dizziness, insomnia, and hallucinations. Conclusion: Pramipexole was well tolerated for up to 4 years. Pramipexole treatment appeared to show continued efficacy in the treatment of Parkinson's disease for 3 years in this open-label descriptive study. After 3 years there was a gradual return to baseline motor states perhaps suggesting progression of Parkinson's disease.</abstract><note type="content">Table 1: Baseline demographics</note><note type="content">Table 2: Baseline PD characteristics at entry</note><note type="content">Table 3: Overall most common (≥10%) adverse events in all patients related to pramipexole</note><note type="content">Table 4: Percent prevalence of adverse events over the duration of treatment</note><note type="content">Table 5: Efficacy endpoints (improvement in UPDRS scores from baseline is indicated by negative numbers; improvement in Schwab and England scale is indicated by positive numbers; and #refers to protocol visit number)</note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>Pramipexole</topic><topic>Safety</topic><topic>Efficacy</topic></subject><relatedItem type="host"><titleInfo><title>Parkinsonism and Related Disorders</title></titleInfo><titleInfo type="abbreviated"><title>PRD</title></titleInfo><genre type="Journal">journal</genre><originInfo><dateIssued encoding="w3cdtf">200104</dateIssued></originInfo><identifier type="ISSN">1353-8020</identifier><identifier type="PII">S1353-8020(00)X0024-7</identifier><part><date>200104</date><detail type="volume"><number>7</number><caption>vol.</caption></detail><detail type="issue"><number>2</number><caption>no.</caption></detail><extent unit="issue pages"><start>81</start><end>162</end></extent><extent unit="pages"><start>115</start><end>120</end></extent></part></relatedItem><identifier type="istex">0842CF509A52EE9F6DB421C407B58B6A123DA80F</identifier><identifier type="DOI">10.1016/S1353-8020(00)00031-6</identifier><identifier type="PII">S1353-8020(00)00031-6</identifier><accessCondition type="use and reproduction" contentType="">© 2001Elsevier Science Ltd</accessCondition><recordInfo><recordContentSource>ELSEVIER</recordContentSource><recordOrigin>Elsevier Science Ltd, ©2001</recordOrigin></recordInfo></mods></metadata><enrichments><istex:catWosTEI uri="https://api.istex.fr/document/0842CF509A52EE9F6DB421C407B58B6A123DA80F/enrichments/catWos"><teiHeader><profileDesc><textClass><classCode scheme="WOS">CLINICAL NEUROLOGY</classCode></textClass></profileDesc></teiHeader></istex:catWosTEI></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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