Duration of “Good On” time per dose: Immediate-release carbidopa-levodopa vs. extended-release carbidopa-levodopa (IPX203, CREXONT®)

IF 3.1 3区医学 Q2 CLINICAL NEUROLOGY Parkinsonism & related disorders Pub Date : 2025-02-01 DOI:10.1016/j.parkreldis.2024.107239

R.A. Hauser , H.H. Fernandez , J. Jimenez-Shahed , S. Allard , G. Banisadr , S. Fisher , R. D'Souza

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Abstract

Background

For Parkinson's disease patients with motor fluctuations, the duration of benefit per levodopa dose is a key metric that reflects a patient's clinical response.

Objective

Determine the difference in mean durations of “Good On” time per dose of subjects randomized to extended-release carbidopa-levodopa (ER CD-LD; IPX203; CREXONT®) vs. immediate-release (IR) CD-LD in the RISE-PD trial.

Methods

“Good On” time per dose was assessed at the end of the IR CD-LD dose adjustment phase (Visit 2/Week 3) and compared to End of Study (Visit 7/EOS) between IPX203 and IR CD-LD groups. In addition, to understand if “Good On” time per dose for IR CD-LD before conversion to IPX203 could impact the magnitude of change in “Good On” time per dose of IPX203 vs. IR CD-LD after conversion, subjects were rank-ordered and divided into quartiles based on their initial “Good On” time per dose optimized IR CD-LD values. Changes in “Good On” time per dose between IPX203 and IR CD-LD groups were then compared for each quartile from Visit 2 to EOS.

Results

IPX203 increased “Good On” time per dose compared to IR CD-LD by a mean of 1.6 h (p < 0.0001). The mean differences in “Good On” time per dose between IPX203 and IR CD-LD were 1.53h for quartile one, 1.39h for quartile two, 1.83h for quartile three, and 1.56h for quartile four (p < 0.0001 for all quartiles).

Conclusion

IPX203 significantly increased “Good On” time per dose regardless of the duration of “Good On” time per dose observed with IR CD-LD.

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每次给药的“有效”时间：卡比多巴-左旋多巴速释与卡比多巴-左旋多巴缓释（IPX203, CREXONT®）

背景：对于运动波动的帕金森病患者，每次左旋多巴剂量的获益持续时间是反映患者临床反应的关键指标。目的：确定随机分配给卡比多巴-左旋多巴缓释片（ER CD-LD）的受试者每次剂量的平均“开启”时间的差异；IPX203;CREXONT®)与即刻释放（IR） CD-LD在RISE-PD试验中的对比。方法：在IR CD-LD剂量调整阶段（第2次访问/第3周）结束时评估每次剂量的“良好开启”时间，并与IPX203组和IR CD-LD组的研究结束（第7次访问/EOS）进行比较。此外，为了了解转换为IPX203前IR CD-LD的每剂量“良好开启”时间是否会影响转换后IPX203与IR CD-LD的每剂量“良好开启”时间的变化程度，根据受试者初始的每剂量优化IR CD-LD值的“良好开启”时间对受试者进行排序并分为四分位数。然后比较IPX203组和IR CD-LD组从第2次访问到EOS的每个四分位数之间的每次剂量“良好启动”时间的变化。结果：与IR CD-LD相比，IPX203使每次剂量的“良好启动”时间平均增加1.6 h (p)。结论：IPX203显著增加了每次剂量的“良好启动”时间，与IR CD-LD观察到的每次剂量“良好启动”时间的持续时间无关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Parkinsonism & related disorders 医学-临床神经学

CiteScore

6.20

自引率

4.90%

发文量

292

审稿时长

39 days

期刊介绍： Parkinsonism & Related Disorders publishes the results of basic and clinical research contributing to the understanding, diagnosis and treatment of all neurodegenerative syndromes in which Parkinsonism, Essential Tremor or related movement disorders may be a feature. Regular features will include: Review Articles, Point of View articles, Full-length Articles, Short Communications, Case Reports and Letter to the Editor.