Dyskinesia and Pain in Advanced Parkinson's Disease: Post Hoc Analysis from the Phase 3b, Open-Label, Randomized DYSCOVER Study.

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2024-04-01 Epub Date: 2024-02-12 DOI:10.1007/s40120-024-00583-z

Eric Freire-Alvarez, Paola Vanni, Egon Kurča, Lydia Lopez-Manzanares, Norbert Kovács, Cleanthe Spanaki, Tianming Gao, Lars Bergmann, Olga Sánchez-Soliño

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引用次数: 0

Abstract

Introduction: The DYSCOVER study was a phase 3b, open-label, randomized trial (NCT02799381) that evaluated levodopa-carbidopa intestinal gel (LCIG) versus optimized medical treatment (OMT) in patients with Parkinson's disease (PD) and a high burden of dyskinesia at baseline (defined as Unified Dyskinesia Rating Scale [UDysRS] total score ≥ 30). At week 12, patients receiving LCIG versus OMT experienced significant improvements in dyskinesia, pain, and health-related outcomes. The objective of this analysis was to examine correlations between dyskinesia, pain, and health-related outcomes in PD.

Methods: This post hoc analysis assessed correlations between UDysRS, King's Parkinson's Disease Pain Scale (KPPS), 8-item Parkinson's Disease Questionnaire (PDQ-8), Unified Parkinson's Disease Rating Scale part II, Clinical Global Impression of Severity (CGI-S) or Change (CGI-C), and "On" time without troublesome dyskinesia at baseline and after 12 weeks of LCIG or OMT. Correlations were assessed by Pearson correlation coefficients (categorization: weak, r = 0.20-0.39; moderate, r = 0.40-0.59; strong, r ≥ 0.60).

Results: Among 61 patients, moderate-to-strong positive and significant correlations were observed between UDysRS and KPPS scores (baseline, r = 0.47; week 12 change from baseline [CFB], r = 0.63; all p < 0.001). UDysRS and KPPS scores had moderate-to-strong positive and highly significant correlations with PDQ-8 scores (baseline, r = 0.45 and 0.46, respectively; CFB, r = 0.54 and 0.64, respectively; all p < 0.001). Moderate positive and significant correlations were observed between UDysRS and CGI-S/CGI-C scores (baseline, r = 0.41; CFB, r = 0.47; all p < 0.001).

Conclusions: In patients with high dyskinesia burden, positive correlations were observed between dyskinesia, pain, and health-related quality of life (HRQoL) at baseline. Improvements in dyskinesia and pain were associated with improvements in HRQoL, demonstrating the clinical burden of troublesome dyskinesia.

Trial registration number: Clinicaltrials.gov identifier NCT02799381.

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晚期帕金森病的运动障碍和疼痛：3b期开放标签随机DYSCOVER研究的事后分析

简介：DYSCOVER研究是一项3b期开放标签随机试验（NCT02799381），该试验评估了左旋多巴-卡比多巴肠道凝胶（LCIG）与优化药物治疗（OMT）在帕金森病（PD）患者中的应用情况，帕金森病患者基线运动障碍负担较重（定义为统一运动障碍评定量表[UDysRS]总分≥30分）。第 12 周时，接受 LCIG 与 OMT 治疗的患者在运动障碍、疼痛和健康相关结果方面均有显著改善。本分析旨在研究运动障碍、疼痛和帕金森病健康相关结果之间的相关性：这项事后分析评估了 UDysRS、King's 帕金森病疼痛量表 (KPPS)、8 项帕金森病问卷 (PDQ-8)、统一帕金森病评定量表第二部分、临床严重性总体印象 (CGI-S) 或变化 (CGI-C) 以及基线和接受 LCIG 或 OMT 治疗 12 周后无运动障碍 "On "时间之间的相关性。相关性通过皮尔逊相关系数进行评估（分类：弱，r = 0.20-0.39；中度，r = 0.40-0.59；强，r ≥ 0.60）：在61名患者中，UDysRS与KPPS评分之间存在中度至高度的显著正相关（基线，r = 0.47；第12周与基线相比的变化[CFB]，r = 0.63；均为p 结论：在高度运动障碍患者中，UDysRS与KPPS评分之间存在显著正相关（基线，r = 0.47；第12周与基线相比的变化[CFB]，r = 0.63；均为p在运动障碍负担较重的患者中，基线时运动障碍、疼痛和健康相关生活质量（HRQoL）之间呈正相关。运动障碍和疼痛的改善与 HRQoL 的改善相关，这表明了麻烦性运动障碍的临床负担：试验注册号：Clinicaltrials.gov 识别码 NCT02799381。

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

期刊介绍： Aims and Scope Neurology and Therapy aims to provide reliable and inclusive, rapid publication for all therapy related research for neurological indications, supporting the timely dissemination of research with a global reach, to help advance scientific discovery and support clinical practice. Neurology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of neurological and psychiatric therapies, (also covering surgery and devices). Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial designs, communications and letters. 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