Safinamide in Clinical Practice: A Spanish Multicenter Cohort Study
Safinamide in Clinical Practice: A Spanish Multicenter Cohort Study
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DOI：
10.3390/brainsci9100272
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发表时间：
2019-10-01
期刊：
影响因子：
3.3
通讯作者：
Rosario Luquin, Ma
中科院分区：
文献类型：
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作者：
Marti-Andres, Gloria;Jimenez-Bolanos, Rayco;Rosario Luquin, Ma
背景：沙芬酰胺是一种批准的药物，用于治疗帕金森病（PD）患者的运动波动，对非运动症状（NMS）具有潜在益处。方法：进行回顾性多中心队列研究，通过临床总体印象变化量表评估沙芬酰胺对运动和 NMS 的临床效果。此外，我们评估了不良事件 (AE) 的出现及其对运动障碍的影响，这些不良事件也在非波动性 PD 患者和既往接受雷沙吉兰治疗的患者中进行了记录。结果：我们纳入了 213 名 PD 患者，他们在常规左旋多巴治疗的基础上接受了沙芬酰胺治疗。 35 人过早退出沙芬酰胺，主要是因为 AE。在 178 名患者中，运动和 NMS 的临床改善分别为 76.4% 和 26.2%。总共报告了 44 起轻度 AE。在比较之前服用或未服用单胺氧化酶 B 抑制剂 (MAOB-I) 的患者或有或没有运动并发症的患者之间，我们没有发现临床获益或 AE 存在差异。结论：沙芬酰胺是一种有效且安全的左旋多巴药物治疗 PD 患者的辅助药物。此外，沙芬酰胺可以使先前接受其他 MAOB-I 治疗的 PD 患者以及运动控制不佳的非波动患者获得额外的临床改善。
Background: Safinamide is an approved drug for the treatment of motor fluctuations of Parkinson's Disease (PD) patients with a potential benefit on non-motor symptoms (NMS). Methods: A retrospective multicenter cohort study was conducted, in which the clinical effect of safinamide on both motor and NMS was assessed by the Clinical Global Impression of Change scale. Furthermore, we assessed the appearance of adverse events (AEs) and its effect on dyskinesia, that were also recorded in non-fluctuating PD patients and in those previously treated with rasagiline. Results: We included 213 PD patients who received safinamide in addition to their regular levodopa therapy. Thirty-five withdrew prematurely from safinamide, mainly because of AEs. Out of 178, clinical improvement on motor and NMS was found in 76.4% and 26.2%, respectively. A total of 44 reported AEs of mild intensity. We did not find a difference concerning the clinical benefit or AEs when comparing either patients who had or had not been taking Monoamine Oxidase B Inhibitor (MAOB-I) previously or between patients with and without motor complications. Conclusions: Safinamide is an effective and safe add-on to levodopa drug for PD patients. Moreover, safinamide could elicit an additional clinical improvement in PD patients previously treated with other MAOB-I and in non- fluctuating patients with suboptimal motor control.