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
Links to Exploration step
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<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>
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<notesStmt><note type="content">*This study was supported by GlaxoSmithKline (GSK) Research and Development, Greenford, United Kingdom.</note>
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<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>
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<affiliation>Department of Neurology, Institute of Research and Medical Care, IRCCS San Raffaele Roma, Rome, Italy</affiliation>
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<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>
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<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>
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<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>
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<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>
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<titleGroup><title type="articleCategory">Research Article</title>
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<copyright ownership="thirdParty">Copyright © 2011 Movement Disorder Society</copyright>
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<correspondenceTo>Department of Neurology, Institute of Research and Medical Care IRCCS San Raffaele Roma, via della Pisana 235, Rome 00163, Italy</correspondenceTo>
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<titleGroup><title type="main" xml:lang="en">PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease<link href="#fn10"></link>
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<title type="short" xml:lang="en">Ropinirole PR Versus IR: The Prepared Study</title>
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<creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes" noteRef="#fn7"><personName><givenNames>Fabrizio</givenNames>
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<creator xml:id="au2" creatorRole="author" affiliationRef="#af2" noteRef="#fn7"><personName><givenNames>Luigi</givenNames>
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<creator xml:id="au3" creatorRole="author" affiliationRef="#af3" noteRef="#fn7"><personName><givenNames>Brian</givenNames>
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<creator xml:id="au4" creatorRole="author" affiliationRef="#af4" noteRef="#fn7"><personName><givenNames>Anthony HV</givenNames>
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<affiliation xml:id="af2" countryCode="GB" type="organization"><unparsedAffiliation>GlaxoSmithKline, Greenford, United Kingdom</unparsedAffiliation>
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<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>
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<supportingInformation><p> Additional Supporting Information may be found in the online version of this article. </p>
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<caption>Supporting Figure 1</caption>
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<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>
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<noteGroup><note xml:id="fn10"><p>This study was supported by GlaxoSmithKline (GSK) Research and Development, Greenford, United Kingdom.</p>
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<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>
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<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>
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