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

AbstractBACKGROUND:
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.
AuthorsFabrizio Stocchi, Luigi Giorgi, Brian Hunter, Anthony H V Schapira
JournalMovement disorders : official journal of the Movement Disorder Society (Mov Disord) Vol. 26 Issue 7 Pg. 1259-65 (Jun 2011) ISSN: 1531-8257 [Electronic] United States
PMID21469195 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2011 Movement Disorder Society.
Chemical References
  • Antiparkinson Agents
  • Delayed-Action Preparations
  • Indoles
  • ropinirole
  • Levodopa
Topics
  • Aged
  • Antiparkinson Agents (administration & dosage, adverse effects)
  • Delayed-Action Preparations (administration & dosage, adverse effects)
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Indoles (administration & dosage, adverse effects)
  • Levodopa (administration & dosage)
  • Male
  • Middle Aged
  • Parkinson Disease (drug therapy)
  • Severity of Illness Index
  • Treatment Outcome

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