奥匹卡朋用于治疗左旋多巴治疗帕金森病的早期停药:两项随机开放标签研究的患者水平数据汇总分析。

IF 4.8 2区 医学 Q1 CLINICAL NEUROLOGY
Journal of Neurology Pub Date : 2024-10-01 Epub Date: 2024-08-21 DOI:10.1007/s00415-024-12614-8
Joaquim J Ferreira, Jee-Young Lee, Hyeo-Il Ma, Beomseok Jeon, Werner Poewe, Angelo Antonini, Fabrizio Stocchi, Daniela M Rodrigues, Miguel M Fonseca, Guillermo Castilla-Fernández, Joerg Holenz, José-Francisco Rocha, Olivier Rascol
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引用次数: 0

摘要

背景:对于接受左旋多巴治疗的帕金森病(PD)患者来说,"药效消失 "现象是导致其换药的主要原因。常见的一线方案包括增加左旋多巴剂量或添加儿茶酚-O-甲基转移酶(COMT)抑制剂,但目前还没有比较这些方法疗效的试验。我们利用 2 项随机研究的汇总数据,评估了辅助性阿哌卡朋与额外 100 毫克左旋多巴剂量对早期消退型帕金森病患者的疗效:ADOPTION研究项目包括在韩国(NCT04821687)和欧洲(NCT04990284)进行的两项设计相似的4周开放标签研究。每天接受 3-4 次左旋多巴治疗并有早期失效迹象的帕金森病患者被随机(1:1)分配到阿哌卡蓬 50 毫克或额外剂量左旋多巴 100 毫克的辅助治疗中。对两项研究的患者数据进行了汇总:从基线到第4周的绝对关闭时间(关键终点)的调整后平均值[SE]变化为:阿哌卡朋组-62.8分钟[8.8],左旋多巴100毫克组-33.8分钟[9.0],阿哌卡朋组的差异显著(- 29.0 [- 53.8, - 4.2]分钟,P = 0.02)。运动障碍协会-统一帕金森病评分量表第三部分子评分(阿哌卡朋为-4.1,左旋多巴100毫克为-2.5)的显著差异也有利于阿哌卡朋(-1.7 [- 3.3, - 0.04],p 结论:阿哌卡朋和左旋多巴100毫克组之间的差异显著(-29.0 [- 53.8, - 4.2]分钟,p = 0.02):在这些短期试验中,对于出现早期停药症状的帕金森病患者,辅助使用阿哌卡彭比增加 100 毫克左旋多巴剂量更能有效缩短停药时间。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Opicapone for the treatment of early wearing-off in levodopa-treated Parkinson's disease: pooled analysis of patient level data from two randomized open-label studies.

Opicapone for the treatment of early wearing-off in levodopa-treated Parkinson's disease: pooled analysis of patient level data from two randomized open-label studies.

Background: The wearing-off phenomenon is a key driver of medication change for patients with Parkinson's disease (PD) treated with levodopa. Common first-line options include increasing the levodopa dose or adding a catechol-O-methyltransferase (COMT) inhibitor, but there are no trials comparing the efficacy of these approaches. We evaluated the effectiveness of adjunct opicapone versus an additional 100 mg levodopa dose in PD patients with early wearing-off using pooled data from 2 randomized studies.

Methods: The ADOPTION study program included two similarly designed 4-week, open-label studies conducted in South Korea (NCT04821687) and Europe (NCT04990284). Patients with PD, treated with 3-4 daily doses of levodopa therapy and with signs of early wearing-off were randomized (1:1) to adjunct opicapone 50 mg or an additional dose of levodopa 100 mg. Patient-level data from the two studies were pooled.

Results: The adjusted mean [SE] change from baseline to week 4 in absolute OFF time (key endpoint) was - 62.8 min [8.8] in the opicapone group and - 33.8 min [9.0] in the levodopa 100 mg group, the difference significantly favoring opicapone (- 29.0 [- 53.8, - 4.2] min, p = 0.02). Significant differences in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III subscore (- 4.1 with opicapone vs - 2.5 with levodopa 100 mg), also favored opicapone (- 1.7 [- 3.3, - 0.04], p < 0.05). Dyskinesia was the most frequently reported adverse event (opicapone 7.2% vs. levodopa 100 mg 4.2%).

Conclusions: In these short-term trials, introducing adjunct opicapone was more effective at reducing OFF time than adding another 100 mg levodopa dose in PD patients with early signs of wearing-off.

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来源期刊
Journal of Neurology
Journal of Neurology 医学-临床神经学
CiteScore
10.00
自引率
5.00%
发文量
558
审稿时长
1 months
期刊介绍: The Journal of Neurology is an international peer-reviewed journal which provides a source for publishing original communications and reviews on clinical neurology covering the whole field. In addition, Letters to the Editors serve as a forum for clinical cases and the exchange of ideas which highlight important new findings. A section on Neurological progress serves to summarise the major findings in certain fields of neurology. Commentaries on new developments in clinical neuroscience, which may be commissioned or submitted, are published as editorials. Every neurologist interested in the current diagnosis and treatment of neurological disorders needs access to the information contained in this valuable journal.
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