PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease
Identifieur interne : 000802 ( Istex/Corpus ); précédent : 000801; suivant : 000803PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease
Auteurs : Fabrizio Stocchi ; Luigi Giorgi ; Brian Hunter ; Anthony Hv SchapiraSource :
- Movement Disorders [ 0885-3185 ] ; 2011-06.
English descriptors
Abstract
Background: PREPARED was a randomized, parallel‐group, double‐blind, multicenter study to evaluate the efficacy of adjunctive ropinirole prolonged release (PR) versus immediate release (IR) in patients with advanced Parkinson's disease (PD). Methods: Patients received once‐daily PR (2–24 mg/d; n = 177) or three‐times‐daily IR (0.75–24 mg/d; n = 173) for 24 weeks. The primary endpoint was the proportion of patients maintaining ≥20% reduction from baseline in “off” time over two consecutive visits at Week 24 last observation carried forward (LOCF). Results: At Week 24 LOCF, PR significantly increased the proportion of patients maintaining ≥20% reduction in “off” time versus IR (adjusted odds ratio: 1.82; 95% CI: 1.16, 2.86; P = 0.009). Mean (SD) doses at Week 24 LOCF were: PR, 18.6 (6.5) mg/d; IR, 10.4 (6.4) mg/d; mean (SD) reductions from baseline in levodopa (L‐dopa) dose were –162 (226) mg and –113 (138) mg, respectively. Adverse events (AEs) were reported by 72% of patients in the PR group and 61% in the IR group; 12% and 9% of patients, respectively, withdrew from the study due to an AE, and 6% and 5%, respectively, reported serious AEs. Conclusions: Adjunctive PR provided a significantly greater improvement in symptom control in terms of the odds of achieving ≥20% maintained reduction in time spent “off” compared with IR. Interpretation may be confounded by the higher doses of PR versus IR that were achieved, in combination with lower doses of L‐dopa by the study end. Despite dosing differences, the PR titration regimen was generally well tolerated, with an AE profile similar to that of IR. © 2011 Movement Disorder Society
Url:
DOI: 10.1002/mds.23498
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ISTEX:49FDA753190EDFEEB695C4DF604D6BFAA634EB3ELe document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease</title><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation><mods:affiliation>Department of Neurology, Institute of Research and Medical Care, IRCCS San Raffaele Roma, Rome, Italy</mods:affiliation></affiliation></author><author><name sortKey="Giorgi, Luigi" sort="Giorgi, Luigi" uniqKey="Giorgi L" first="Luigi" last="Giorgi">Luigi Giorgi</name><affiliation><mods:affiliation>GlaxoSmithKline, Greenford, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Hunter, Brian" sort="Hunter, Brian" uniqKey="Hunter B" first="Brian" last="Hunter">Brian Hunter</name><affiliation><mods:affiliation>GlaxoSmithKline, Harlow, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Schapira, Anthony Hv" sort="Schapira, Anthony Hv" uniqKey="Schapira A" first="Anthony Hv" last="Schapira">Anthony Hv Schapira</name><affiliation><mods:affiliation>Department of Clinical Neurosciences, Institute of Neurology, Queen Square, University College, London, United Kingdom</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:49FDA753190EDFEEB695C4DF604D6BFAA634EB3E</idno><date when="2011" year="2011">2011</date><idno type="doi">10.1002/mds.23498</idno><idno type="url">https://api.istex.fr/document/49FDA753190EDFEEB695C4DF604D6BFAA634EB3E/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000802</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease</title><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation><mods:affiliation>Department of Neurology, Institute of Research and Medical Care, IRCCS San Raffaele Roma, Rome, Italy</mods:affiliation></affiliation></author><author><name sortKey="Giorgi, Luigi" sort="Giorgi, Luigi" uniqKey="Giorgi L" first="Luigi" last="Giorgi">Luigi Giorgi</name><affiliation><mods:affiliation>GlaxoSmithKline, Greenford, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Hunter, Brian" sort="Hunter, Brian" uniqKey="Hunter B" first="Brian" last="Hunter">Brian Hunter</name><affiliation><mods:affiliation>GlaxoSmithKline, Harlow, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Schapira, Anthony Hv" sort="Schapira, Anthony Hv" uniqKey="Schapira A" first="Anthony Hv" last="Schapira">Anthony Hv Schapira</name><affiliation><mods:affiliation>Department of Clinical Neurosciences, Institute of Neurology, Queen Square, University College, London, United Kingdom</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="2011-06">2011-06</date><biblScope unit="vol">26</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="1259">1259</biblScope><biblScope unit="page" to="1265">1265</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">49FDA753190EDFEEB695C4DF604D6BFAA634EB3E</idno><idno type="DOI">10.1002/mds.23498</idno><idno type="ArticleID">MDS23498</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>motor fluctuations</term><term>once‐daily treatment</term><term>ropinirole</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: PREPARED was a randomized, parallel‐group, double‐blind, multicenter study to evaluate the efficacy of adjunctive ropinirole prolonged release (PR) versus immediate release (IR) in patients with advanced Parkinson's disease (PD). Methods: Patients received once‐daily PR (2–24 mg/d; n = 177) or three‐times‐daily IR (0.75–24 mg/d; n = 173) for 24 weeks. The primary endpoint was the proportion of patients maintaining ≥20% reduction from baseline in “off” time over two consecutive visits at Week 24 last observation carried forward (LOCF). Results: At Week 24 LOCF, PR significantly increased the proportion of patients maintaining ≥20% reduction in “off” time versus IR (adjusted odds ratio: 1.82; 95% CI: 1.16, 2.86; P = 0.009). Mean (SD) doses at Week 24 LOCF were: PR, 18.6 (6.5) mg/d; IR, 10.4 (6.4) mg/d; mean (SD) reductions from baseline in levodopa (L‐dopa) dose were –162 (226) mg and –113 (138) mg, respectively. Adverse events (AEs) were reported by 72% of patients in the PR group and 61% in the IR group; 12% and 9% of patients, respectively, withdrew from the study due to an AE, and 6% and 5%, respectively, reported serious AEs. Conclusions: Adjunctive PR provided a significantly greater improvement in symptom control in terms of the odds of achieving ≥20% maintained reduction in time spent “off” compared with IR. Interpretation may be confounded by the higher doses of PR versus IR that were achieved, in combination with lower doses of L‐dopa by the study end. Despite dosing differences, the PR titration regimen was generally well tolerated, with an AE profile similar to that of IR. © 2011 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Fabrizio Stocchi MD, PhD</name><affiliations><json:string>Department of Neurology, Institute of Research and Medical Care, IRCCS San Raffaele Roma, Rome, Italy</json:string></affiliations></json:item><json:item><name>Luigi Giorgi MD</name><affiliations><json:string>GlaxoSmithKline, Greenford, United Kingdom</json:string></affiliations></json:item><json:item><name>Brian Hunter PhD</name><affiliations><json:string>GlaxoSmithKline, Harlow, United Kingdom</json:string></affiliations></json:item><json:item><name>Anthony HV Schapira MD, DSc</name><affiliations><json:string>Department of Clinical Neurosciences, Institute of Neurology, Queen Square, University College, London, United Kingdom</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>once‐daily treatment</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>ropinirole</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>motor fluctuations</value></json:item></subject><language><json:string>eng</json:string></language><abstract>Background: PREPARED was a randomized, parallel‐group, double‐blind, multicenter study to evaluate the efficacy of adjunctive ropinirole prolonged release (PR) versus immediate release (IR) in patients with advanced Parkinson's disease (PD). Methods: Patients received once‐daily PR (2–24 mg/d; n = 177) or three‐times‐daily IR (0.75–24 mg/d; n = 173) for 24 weeks. The primary endpoint was the proportion of patients maintaining ≥20% reduction from baseline in “off” time over two consecutive visits at Week 24 last observation carried forward (LOCF). Results: At Week 24 LOCF, PR significantly increased the proportion of patients maintaining ≥20% reduction in “off” time versus IR (adjusted odds ratio: 1.82; 95% CI: 1.16, 2.86; P = 0.009). Mean (SD) doses at Week 24 LOCF were: PR, 18.6 (6.5) mg/d; IR, 10.4 (6.4) mg/d; mean (SD) reductions from baseline in levodopa (L‐dopa) dose were –162 (226) mg and –113 (138) mg, respectively. Adverse events (AEs) were reported by 72% of patients in the PR group and 61% in the IR group; 12% and 9% of patients, respectively, withdrew from the study due to an AE, and 6% and 5%, respectively, reported serious AEs. Conclusions: Adjunctive PR provided a significantly greater improvement in symptom control in terms of the odds of achieving ≥20% maintained reduction in time spent “off” compared with IR. Interpretation may be confounded by the higher doses of PR versus IR that were achieved, in combination with lower doses of L‐dopa by the study end. Despite dosing differences, the PR titration regimen was generally well tolerated, with an AE profile similar to that of IR. © 2011 Movement Disorder Society</abstract><qualityIndicators><score>7.286</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1654</abstractCharCount><pdfWordCount>4286</pdfWordCount><pdfCharCount>26777</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>264</abstractWordCount></qualityIndicators><title>PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease</title><genre><json:string>Serial article</json:string></genre><host><volume>26</volume><pages><total>7</total><last>1265</last><first>1259</first></pages><issn><json:string>0885-3185</json:string></issn><issue>7</issue><subject><json:item><value>Research Article</value></json:item></subject><genre></genre><language><json:string>unknown</json:string></language><title>Movement Disorders</title><doi><json:string>10.1002/(ISSN)1531-8257</json:string></doi></host><publicationDate>2011</publicationDate><copyrightDate>2011</copyrightDate><doi><json:string>10.1002/mds.23498</json:string></doi><id>49FDA753190EDFEEB695C4DF604D6BFAA634EB3E</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/49FDA753190EDFEEB695C4DF604D6BFAA634EB3E/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/49FDA753190EDFEEB695C4DF604D6BFAA634EB3E/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/49FDA753190EDFEEB695C4DF604D6BFAA634EB3E/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>Wiley Subscription Services, Inc., A Wiley Company</p></availability><date>2011</date></publicationStmt><notesStmt><note type="content">*This study was supported by GlaxoSmithKline (GSK) Research and Development, Greenford, United Kingdom.</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease</title><author><persName><forename type="first">Fabrizio</forename><surname>Stocchi</surname><roleName type="degree">MD, PhD</roleName></persName><note type="biography">Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</note><affiliation>Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</affiliation><note type="correspondence"><p>Correspondence: Department of Neurology, Institute of Research and Medical Care IRCCS San Raffaele Roma, via della Pisana 235, Rome 00163, Italy</p></note><affiliation>Department of Neurology, Institute of Research and Medical Care, IRCCS San Raffaele Roma, Rome, Italy</affiliation></author><author><persName><forename type="first">Luigi</forename><surname>Giorgi</surname><roleName type="degree">MD</roleName></persName><note type="biography">Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</note><affiliation>Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</affiliation><affiliation>GlaxoSmithKline, Greenford, United Kingdom</affiliation></author><author><persName><forename type="first">Brian</forename><surname>Hunter</surname><roleName type="degree">PhD</roleName></persName><note type="biography">Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</note><affiliation>Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</affiliation><affiliation>GlaxoSmithKline, Harlow, United Kingdom</affiliation></author><author><persName><forename type="first">Anthony HV</forename><surname>Schapira</surname><roleName type="degree">MD, DSc</roleName></persName><note type="biography">Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</note><affiliation>Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</affiliation><affiliation>Department of Clinical Neurosciences, Institute of Neurology, Queen Square, University College, London, United Kingdom</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="2011-06"></date><biblScope unit="vol">26</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="1259">1259</biblScope><biblScope unit="page" to="1265">1265</biblScope></imprint></monogr><idno type="istex">49FDA753190EDFEEB695C4DF604D6BFAA634EB3E</idno><idno type="DOI">10.1002/mds.23498</idno><idno type="ArticleID">MDS23498</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2011</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Background: PREPARED was a randomized, parallel‐group, double‐blind, multicenter study to evaluate the efficacy of adjunctive ropinirole prolonged release (PR) versus immediate release (IR) in patients with advanced Parkinson's disease (PD). Methods: Patients received once‐daily PR (2–24 mg/d; n = 177) or three‐times‐daily IR (0.75–24 mg/d; n = 173) for 24 weeks. The primary endpoint was the proportion of patients maintaining ≥20% reduction from baseline in “off” time over two consecutive visits at Week 24 last observation carried forward (LOCF). Results: At Week 24 LOCF, PR significantly increased the proportion of patients maintaining ≥20% reduction in “off” time versus IR (adjusted odds ratio: 1.82; 95% CI: 1.16, 2.86; P = 0.009). Mean (SD) doses at Week 24 LOCF were: PR, 18.6 (6.5) mg/d; IR, 10.4 (6.4) mg/d; mean (SD) reductions from baseline in levodopa (L‐dopa) dose were –162 (226) mg and –113 (138) mg, respectively. Adverse events (AEs) were reported by 72% of patients in the PR group and 61% in the IR group; 12% and 9% of patients, respectively, withdrew from the study due to an AE, and 6% and 5%, respectively, reported serious AEs. Conclusions: Adjunctive PR provided a significantly greater improvement in symptom control in terms of the odds of achieving ≥20% maintained reduction in time spent “off” compared with IR. Interpretation may be confounded by the higher doses of PR versus IR that were achieved, in combination with lower doses of L‐dopa by the study end. Despite dosing differences, the PR titration regimen was generally well tolerated, with an AE profile similar to that of IR. © 2011 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>once‐daily treatment</term></item><item><term>ropinirole</term></item><item><term>Parkinson's disease</term></item><item><term>motor fluctuations</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="2010-05-19">Received</change><change when="2010-09-29">Registration</change><change when="2011-06">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/49FDA753190EDFEEB695C4DF604D6BFAA634EB3E/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="70"><doi origin="wiley" registered="yes">10.1002/mds.v26.7</doi><numberingGroup><numbering type="journalVolume" number="26">26</numbering><numbering type="journalIssue">7</numbering></numberingGroup><coverDate startDate="2011-06">June 2011</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="150" status="forIssue"><doi origin="wiley" registered="yes">10.1002/mds.23498</doi><idGroup><id type="unit" value="MDS23498"></id></idGroup><countGroup><count type="pageTotal" number="7"></count></countGroup><titleGroup><title type="articleCategory">Research Article</title><title type="tocHeading1">Research Articles</title></titleGroup><copyright ownership="thirdParty">Copyright © 2011 Movement Disorder Society</copyright><eventGroup><event type="manuscriptReceived" date="2010-05-19"></event><event type="manuscriptRevised" date="2010-08-11"></event><event type="manuscriptAccepted" date="2010-09-29"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:3.0.1 mode:FullText" date="2011-12-15"></event><event type="publishedOnlineEarlyUnpaginated" date="2011-04-05"></event><event type="publishedOnlineFinalForm" date="2011-06-20"></event><event type="firstOnline" date="2011-04-05"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-02-02"></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">1259</numbering><numbering type="pageLast">1265</numbering></numberingGroup><correspondenceTo>Department of Neurology, Institute of Research and Medical Care IRCCS San Raffaele Roma, via della Pisana 235, Rome 00163, Italy</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS23498.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="10"></count><count type="wordTotal" number="5944"></count></countGroup><titleGroup><title type="main" xml:lang="en">PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease<link href="#fn10"></link></title><title type="short" xml:lang="en">Ropinirole PR Versus IR: The Prepared Study</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes" noteRef="#fn7"><personName><givenNames>Fabrizio</givenNames><familyName>Stocchi</familyName><degrees>MD, PhD</degrees></personName><contactDetails><email>fabrizio.stocchi@fastwebnet.it</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2" noteRef="#fn7"><personName><givenNames>Luigi</givenNames><familyName>Giorgi</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3" noteRef="#fn7"><personName><givenNames>Brian</givenNames><familyName>Hunter</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4" noteRef="#fn7"><personName><givenNames>Anthony HV</givenNames><familyName>Schapira</familyName><degrees>MD, DSc</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="IT" type="organization"><unparsedAffiliation>Department of Neurology, Institute of Research and Medical Care, IRCCS San Raffaele Roma, Rome, Italy</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="GB" type="organization"><unparsedAffiliation>GlaxoSmithKline, Greenford, United Kingdom</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="GB" type="organization"><unparsedAffiliation>GlaxoSmithKline, Harlow, United Kingdom</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="GB" type="organization"><unparsedAffiliation>Department of Clinical Neurosciences, Institute of Neurology, Queen Square, University College, London, United Kingdom</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">once‐daily treatment</keyword><keyword xml:id="kwd2">ropinirole</keyword><keyword xml:id="kwd3">Parkinson's disease</keyword><keyword xml:id="kwd4">motor fluctuations</keyword></keywordGroup><supportingInformation><p> Additional Supporting Information may be found in the online version of this article. </p><supportingInfoItem><mediaResource alt="supporting information" href="urn-x:wiley:08853185:media:mds23498:MDS_23498_sm_suppfig1"></mediaResource><caption>Supporting Figure 1</caption></supportingInfoItem><supportingInfoItem><mediaResource alt="supporting information" href="urn-x:wiley:08853185:media:mds23498:MDS_23498_sm_suppfig2"></mediaResource><caption>Supporting Figure 2</caption></supportingInfoItem></supportingInformation><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Background: PREPARED was a randomized, parallel‐group, double‐blind, multicenter study to evaluate the efficacy of adjunctive ropinirole prolonged release (PR) versus immediate release (IR) in patients with advanced Parkinson's disease (PD). Methods: Patients received once‐daily PR (2–24 mg/d; n = 177) or three‐times‐daily IR (0.75–24 mg/d; n = 173) for 24 weeks. The primary endpoint was the proportion of patients maintaining ≥20% reduction from baseline in “off” time over two consecutive visits at Week 24 last observation carried forward (LOCF). Results: At Week 24 LOCF, PR significantly increased the proportion of patients maintaining ≥20% reduction in “off” time versus IR (adjusted odds ratio: 1.82; 95% CI: 1.16, 2.86; <i>P</i> = 0.009). Mean (SD) doses at Week 24 LOCF were: PR, 18.6 (6.5) mg/d; IR, 10.4 (6.4) mg/d; mean (SD) reductions from baseline in levodopa (<sc>L</sc>‐dopa) dose were –162 (226) mg and –113 (138) mg, respectively. Adverse events (AEs) were reported by 72% of patients in the PR group and 61% in the IR group; 12% and 9% of patients, respectively, withdrew from the study due to an AE, and 6% and 5%, respectively, reported serious AEs. Conclusions: Adjunctive PR provided a significantly greater improvement in symptom control in terms of the odds of achieving ≥20% maintained reduction in time spent “off” compared with IR. Interpretation may be confounded by the higher doses of PR versus IR that were achieved, in combination with lower doses of <sc>L</sc>‐dopa by the study end. Despite dosing differences, the PR titration regimen was generally well tolerated, with an AE profile similar to that of IR. © 2011 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn10"><p>This study was supported by GlaxoSmithKline (GSK) Research and Development, Greenford, United Kingdom.</p></note><note xml:id="fn7"><p><b>Potential conflicts of interest:</b> Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (<i>BMJ</i> 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 3-12-2015--><mods version="3.6"><titleInfo lang="en"><title>PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Ropinirole PR Versus IR: The Prepared Study</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Fabrizio</namePart><namePart type="family">Stocchi</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Department of Neurology, Institute of Research and Medical Care, IRCCS San Raffaele Roma, Rome, Italy</affiliation><description>Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</description><description>Correspondence: Department of Neurology, Institute of Research and Medical Care IRCCS San Raffaele Roma, via della Pisana 235, Rome 00163, Italy</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Luigi</namePart><namePart type="family">Giorgi</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>GlaxoSmithKline, Greenford, United Kingdom</affiliation><description>Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Brian</namePart><namePart type="family">Hunter</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>GlaxoSmithKline, Harlow, United Kingdom</affiliation><description>Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Anthony HV</namePart><namePart type="family">Schapira</namePart><namePart type="termsOfAddress">MD, DSc</namePart><affiliation>Department of Clinical Neurosciences, Institute of Neurology, Queen Square, University College, London, United Kingdom</affiliation><description>Potential conflicts of interest: Fabrizio Stocchi has received honoraria for educational symposia and consultancy to GlaxoSmithKline. Fabrizio Stocchi and all the other participants of the clinical study received payment according to the number of patients included in the trial. Brian Hunter and Luigi Giorgi were employees of GlaxoSmithKline at the time of the study. Anthony HV Schapira has received honoraria for educational symposia and consultancy to GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Medical writing assistance was provided by Caudex Medical (Sarah Brown, MaiLee Wong and Joanna Brown) and was funded by GlaxoSmithKline. Assistance was provided from the outset of the manuscript, with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339 b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the Acknowledgments section of the manuscript.</description><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2011-06</dateIssued><dateCaptured encoding="w3cdtf">2010-05-19</dateCaptured><dateValid encoding="w3cdtf">2010-09-29</dateValid><copyrightDate encoding="w3cdtf">2011</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">2</extent><extent unit="tables">3</extent><extent unit="references">10</extent><extent unit="words">5944</extent></physicalDescription><abstract lang="en">Background: PREPARED was a randomized, parallel‐group, double‐blind, multicenter study to evaluate the efficacy of adjunctive ropinirole prolonged release (PR) versus immediate release (IR) in patients with advanced Parkinson's disease (PD). Methods: Patients received once‐daily PR (2–24 mg/d; n = 177) or three‐times‐daily IR (0.75–24 mg/d; n = 173) for 24 weeks. The primary endpoint was the proportion of patients maintaining ≥20% reduction from baseline in “off” time over two consecutive visits at Week 24 last observation carried forward (LOCF). Results: At Week 24 LOCF, PR significantly increased the proportion of patients maintaining ≥20% reduction in “off” time versus IR (adjusted odds ratio: 1.82; 95% CI: 1.16, 2.86; P = 0.009). Mean (SD) doses at Week 24 LOCF were: PR, 18.6 (6.5) mg/d; IR, 10.4 (6.4) mg/d; mean (SD) reductions from baseline in levodopa (L‐dopa) dose were –162 (226) mg and –113 (138) mg, respectively. Adverse events (AEs) were reported by 72% of patients in the PR group and 61% in the IR group; 12% and 9% of patients, respectively, withdrew from the study due to an AE, and 6% and 5%, respectively, reported serious AEs. Conclusions: Adjunctive PR provided a significantly greater improvement in symptom control in terms of the odds of achieving ≥20% maintained reduction in time spent “off” compared with IR. Interpretation may be confounded by the higher doses of PR versus IR that were achieved, in combination with lower doses of L‐dopa by the study end. Despite dosing differences, the PR titration regimen was generally well tolerated, with an AE profile similar to that of IR. © 2011 Movement Disorder Society</abstract><note type="content">*This study was supported by GlaxoSmithKline (GSK) Research and Development, Greenford, United Kingdom.</note><subject lang="en"><genre>Keywords</genre><topic>once‐daily treatment</topic><topic>ropinirole</topic><topic>Parkinson's disease</topic><topic>motor fluctuations</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. 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