1. Opicapone to Treat Early Wearing-off in Parkinson's Disease Patients: The Korean ADOPTION Trial.
- Author
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Lee JY, Ma HI, Ferreira JJ, Rocha JF, Sung YH, Song IU, Ahn TB, Kwon DY, Cheon SM, Kim JM, Lee CS, Lee PH, Park JH, Lee JH, Park MY, Kim SJ, Baik JS, Choi SM, Shin HW, Lee HW, Kang SY, and Jeon B
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Catechol O-Methyltransferase Inhibitors therapeutic use, Catechol O-Methyltransferase Inhibitors pharmacology, Catechol O-Methyltransferase Inhibitors administration & dosage, Republic of Korea, Treatment Outcome, Parkinson Disease drug therapy, Levodopa therapeutic use, Levodopa administration & dosage, Antiparkinson Agents therapeutic use, Antiparkinson Agents administration & dosage, Oxadiazoles therapeutic use, Oxadiazoles administration & dosage
- Abstract
Background: Increasing levodopa (L-dopa)/dopa decarboxylase inhibitor (DDCI) daily dose or adding a catechol-O-methyltransferase (COMT) inhibitor to levodopa/DDCI therapy are strategies used to manage wearing-off symptoms in Parkinson's disease (PD) patients., Objectives: To evaluate the COMT inhibitor opicapone versus an additional dose of levodopa to treat early wearing-off in PD patients., Methods: ADOPTION was a randomized, parallel-group, open-label, Phase 4 study conducted in Korea. At baseline, eligible patients were randomized (1:1) to opicapone 50 mg (n = 87) or L-dopa 100 mg (n = 81) (added to current L-dopa/DDCI therapy) for 4 weeks. The main efficacy endpoint was change from baseline to end of study in absolute off time. Other endpoints included changes in on time, in Movement Disorder Society-Unified Parkinson's Disease Rating Scale and 8-item PD Questionnaire scores, and the Clinical and Patient Global Impression of Improvement/Change., Results: The adjusted mean in absolute off time was significantly greater for opicapone 50 mg than for L-dopa 100 mg (-62.1 vs. -16.7 minutes; P = 0.0015). Opicapone-treated patients also reported a greater reduction in the percentage of off time (P = 0.0015), a greater increase in absolute on time (P = 0.0338) and a greater increase in the percentage of on time (P = 0.0015). There were no significant differences in other secondary endpoints. The L-dopa equivalent daily dose was significantly higher in the opicapone group (750.9 vs. 690.0 mg; P = 0.0247), when a 0.5 conversion factor is applied., Conclusions: Opicapone 50 mg was more effective than an additional 100 mg L-dopa dose at decreasing off time in patients with PD and early wearing-off., (© 2024 The Authors. Movement Disorders Clinical Practice published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)
- Published
- 2024
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