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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Authors | Fabrizio Stocchi, Luigi Giorgi, Brian Hunter, Anthony H V Schapira |
Journal | Movement 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 |
PMID | 21469195
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2011 Movement Disorder Society. |
Chemical References |
- Antiparkinson Agents
- Delayed-Action Preparations
- Indoles
- ropinirole
- Levodopa
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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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