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

Fabrizio Stocchi, Luigi Giorgi, Brian Hunter, Anthony Hv Schapira

Research output: Contribution to journalArticle

49 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1259-1265
Number of pages7
JournalMovement Disorders
Volume26
Issue number7
DOIs
Publication statusPublished - Jun 2011

Fingerprint

Parkinson Disease
Observation
Levodopa
Double-Blind Method
Multicenter Studies
ropinirole
Odds Ratio

Keywords

  • Motor fluctuations
  • Once-daily treatment
  • Parkinson's disease
  • Ropinirole

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

PREPARED : Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease. / Stocchi, Fabrizio; Giorgi, Luigi; Hunter, Brian; Schapira, Anthony Hv.

In: Movement Disorders, Vol. 26, No. 7, 06.2011, p. 1259-1265.

Research output: Contribution to journalArticle

Stocchi, Fabrizio ; Giorgi, Luigi ; Hunter, Brian ; Schapira, Anthony Hv. / PREPARED : Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease. In: Movement Disorders. 2011 ; Vol. 26, No. 7. pp. 1259-1265.
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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.",
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