INTRODUCTION Safinamide, a selective, reversible monoamine oxidase B inhibitor with a sodium channel inhibitory effect, improves symptoms in advanced Parkinson's disease (PD). This study aimed to confirm the long-term safety and efficacy of safinamide in Japanese PD patients with wearing-off. METHODS Japanese PD patients aged ≥30 years with wearing-off were eligible. The primary efficacy endpoint was change from baseline in the mean daily ON-time without troublesome dyskinesias at 52 weeks of treatment. Other efficacy endpoints included changes from baseline in mean daily OFF-time and unified Parkinson's disease rating scale (UPDRS) and PDQ-39 scores. RESULTS In total, 203 patients entered the study, and 142 completed the 52-week treatment. Adverse events (AEs) occurred in 78.3% of patients, with nasopharyngitis (20.7%) and dyskinesias (17.7%) as the most common; serious AEs occurred in 17.2%, causing discontinuation in 10.8%. At Week 52, the mean daily ON-time without troublesome dyskinesias increased from baseline by 1.42 h. Change from baseline in mean daily OFF-time was -1.40 h, and that in the UPDRS Part III score in the ON-phase was -6.20. CONCLUSIONS As adjunctive treatment with levodopa, safinamide was safe, well tolerated, and effective in improving ON-time and other PD symptoms at 52 weeks.

中文翻译：

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Safinamide 作为附加疗法在接受左旋多巴治疗的日本帕金森病患者逐渐消失的长期安全性和有效性：一项开放标签研究的结果

介绍 Safinamide 是一种选择性、可逆的单胺氧化酶 B 抑制剂，具有钠通道抑制作用，可改善晚期帕金森病 (PD) 的症状。本研究旨在确认 safinamide 在日本 PD 患者逐渐消失中的长期安全性和有效性。方法 年龄≥30 岁且逐渐消退的日本 PD 患者符合条件。主要疗效终点是在治疗 52 周时没有麻烦的运动障碍的平均每日 ON 时间从基线的变化。其他疗效终点包括平均每日关断时间和统一帕金森病评分量表 (UPDRS) 和 PDQ-39 分数相对于基线的变化。结果 共有 203 名患者进入研究，142 名完成了 52 周的治疗。78.3% 的患者发生了不良事件 (AE)，包括鼻咽炎 (20.7%) 和运动障碍 (17. 7%) 作为最常见的；17.2% 发生严重 AE，10.8% 导致停药。在第 52 周，没有麻烦的运动障碍的平均每日开启时间从基线增加了 1.42 小时。与基线相比，每日平均关闭时间的变化为 -1.40 小时，开启阶段的 UPDRS 第三部分评分为 -6.20。结论 作为左旋多巴的辅助治疗，safinamide 是安全的、耐受性良好的，并且在 52 周时可有效改善 ON 时间和其他 PD 症状。