Introduction

The non-dopaminergic and dopaminergic actions of safinamide may alleviate pain in patients with Parkinson's disease (PD). We investigated the efficacy of safinamide for pain when administered as an adjunct to levodopa in Japanese patients with PD.

Methods

This was a post hoc analysis of a phase 2/3 clinical study of safinamide in Japanese patients with PD who were experiencing wearing-off. Pain was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) Part II ‘sensory symptoms’ item 17, on a scale of 0–4, and the 39-item Parkinson's Disease Questionnaire (PDQ-39) ‘bodily discomfort’ domain score. Subgroup analyses, according to baseline symptoms and concomitant medications, were also performed.

Results

Least square (LS) mean changes in the UPDRS item 17 score from baseline to Week 24 in the placebo, safinamide 50-mg and safinamide 100-mg groups during the OFF phase were 0.08, −0.15 (p = 0.0133 vs placebo) and −0.18 (p = 0.0054), respectively, and during the ON phase were 0.04, −0.08 (p = 0.0529) and −0.08 (p = 0.0505), respectively. Changes from baseline to Week 24 in PDQ-39 ‘bodily discomfort’ scores were not significantly different in safinamide groups vs placebo. The presence of moderate-to-severe bradykinesia or early-morning dystonia at baseline resulted in numerically greater effect sizes in UPDRS item 17 scores during the OFF phase.

Conclusions

Safinamide 50 mg and 100 mg reduced the UPDRS item 17 score in patients with PD, especially during the OFF phase. Patients with moderate-to-severe bradykinesia and early-morning dystonia may benefit from safinamide treatment.

中文翻译：

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Safinamide 辅助治疗对帕金森病患者疼痛的影响：日本 2/3 期研究的事后分析

介绍

Safinamide 的非多巴胺能和多巴胺能作用可减轻帕金森病 (PD) 患者的疼痛。我们研究了在日本 PD 患者中作为左旋多巴的辅助给药时，safinamide 对疼痛的疗效。

方法

这是对正在经历消退的日本 PD 患者进行的 safinamide 2/3 期临床研究的事后分析。使用统一帕金森病评定量表 (UPDRS) 第二部分“感觉症状”第 17 项（0-4 分）和 39 项帕金森病问卷 (PDQ-39)“身体不适”领域评分评估疼痛。还根据基线症状和伴随药物进行了亚组分析。

结果

安慰剂、safinamide 50-mg 和 safinamide 100-mg 组在 OFF 阶段从基线到第 24 周 UPDRS 项目 17 评分的最小二乘 (LS) 平均变化为 0.08、-0.15（p  = 0.0133 与安慰剂相比）和 - 0.18 ( p  = 0.0054) 和在 ON 阶段分别为 0.04、-0.08 ( p  = 0.0529) 和 -0.08 ( p  = 0.0505)。safinamide 组与安慰剂组的 PDQ-39“身体不适”评分从基线到第 24 周的变化没有显着差异。基线时中度至重度运动迟缓或清晨肌张力障碍的存在导致在 OFF 阶段期间 UPDRS 第 17 项评分在数值上的影响大小更大。

结论

Safinamide 50 mg 和 100 mg 降低了 PD 患者的 UPDRS 项目 17 评分，尤其是在 OFF 阶段。有中度至重度运动迟缓和清晨肌张力障碍的患者可能受益于 safinamide 治疗。