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PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease

Authors

  • Fabrizio Stocchi MD, PhD,

    Corresponding author
    1. Department of Neurology, Institute of Research and Medical Care, IRCCS San Raffaele Roma, Rome, Italy
    • Department of Neurology, Institute of Research and Medical Care IRCCS San Raffaele Roma, via della Pisana 235, Rome 00163, Italy

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    • 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.

  • Luigi Giorgi MD,

    1. GlaxoSmithKline, Greenford, United Kingdom
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    • 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.

  • Brian Hunter PhD,

    1. GlaxoSmithKline, Harlow, United Kingdom
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    • 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.

  • Anthony HV Schapira MD, DSc

    1. Department of Clinical Neurosciences, Institute of Neurology, Queen Square, University College, London, United Kingdom
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    • 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.


  • This study was supported by GlaxoSmithKline (GSK) Research and Development, Greenford, United Kingdom.

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

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