Department of Neurology, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan.
Medical Headquarters, Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan.
J Neurol Sci. 2021 Oct 15;429:118070. doi: 10.1016/j.jns.2021.118070. Epub 2021 Sep 4.
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.
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.
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.
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.
氨磺必利具有非多巴胺能和多巴胺能作用，可能减轻帕金森病（PD）患者的疼痛。我们研究了氨磺必利与左旋多巴联合用于日本 PD 患者的疼痛疗效。
这是一项氨磺必利治疗日本 PD 患者开-关期波动患者的 2/3 期临床研究的事后分析。使用帕金森病评定量表（UPDRS）第二部分“感觉症状”项目 17 及 39 项帕金森病问卷（PDQ-39）“躯体不适”领域评分来评估疼痛，分值为 0-4。还进行了根据基线症状和伴随药物的亚组分析。
安慰剂、氨磺必利 50mg 和 100mg 组在 OFF 期时，LS 均值自基线至 24 周 UPDRS 项目 17 评分的变化分别为 0.08、-0.15（p=0.0133 与安慰剂相比）和-0.18（p=0.0054），在 ON 期时的变化分别为 0.04、-0.08（p=0.0529）和-0.08（p=0.0505）。与安慰剂相比，氨磺必利组在 PDQ-39“躯体不适”评分上自基线至 24 周的变化无显著差异。基线时存在中重度运动徐缓或晨僵时，在 OFF 期时 UPDRS 项目 17 评分的效应大小更大。
氨磺必利 50mg 和 100mg 降低了 PD 患者的 UPDRS 项目 17 评分，尤其是在 OFF 期。中重度运动徐缓和晨僵患者可能从氨磺必利治疗中获益。
