Hospital de la Santa Creu i Sant Pau, 08025 Barcelona, España.
CIBERNED. Centro de Investigación Biomédica en Red Enfermedades Neurodegenerativas, Madrid, España.
Rev Neurol. 2023 Oct 15;77(s02):1-12. doi: 10.33588/rn.77s02.2023217.
Parkinson's Disease (PD) is a progressive age-related neurodegenerative condition requiring new therapeutic alternatives. Safinamide, a novel levodopa add-on therapy, positively affects disease fluctuations by modulating both dopaminergic and glutamatergic systems. To further investigate the use of safinamide in European routine clinical practice, the present post-hoc analysis aimed to understand safinamide's safety profile within the Spanish study population.
Five hundred eleven Spanish patients with PD were evaluated at baseline, four (±1), eight (±1), and 12 (±1) months after initiating safinamide treatment. Unified Parkinson's Disease Rating Scale (UPDRS) total score and UPDRS part III score during on time were used to measure the overall severity of PD and motor complications, respectively, while the severity of adverse events was evaluated following the investigators' criteria.
Safinamide showed a favourable safety profile within the Spanish study population, although prescription to patients with psychiatric conditions and off-label use were more frequent than in the European study population. In Spain, clinically meaningful improvements were observed in UPDRS scores when safinamide was used as the only add-on therapy to levodopa (57.4% and 53.7% of patients) and when switching from rasagiline (55.1% of patients). Motor complications were reduced from 83.2% to 63.3% after the study period. Increased safety concerns were undetected in any patient subgroup, although patients with cognitive impairment showed a slightly higher frequency of adverse events.
This subanalysis further supports safinamide use as a safe and efficacious option for the management of motor fluctuations in different subgroups of levodopa-treated patients. However, safinamide should be used with caution in patients with cognitive impairment.
帕金森病（PD）是一种进行性、与年龄相关的神经退行性疾病，需要新的治疗选择。沙芬酰胺是一种新型的左旋多巴附加治疗药物，通过调节多巴胺能和谷氨酸能系统，对疾病波动产生积极影响。为了进一步研究沙芬酰胺在欧洲常规临床实践中的应用，本事后分析旨在了解沙芬酰胺在西班牙研究人群中的安全性概况。
511 名西班牙 PD 患者在开始沙芬酰胺治疗前、治疗后 4（±1）、8（±1）和 12（±1）个月时进行评估。统一帕金森病评定量表（UPDRS）总分和 UPDRS 第三部分评分（ON）用于评估 PD 的总体严重程度和运动并发症，而根据研究者的标准评估不良事件的严重程度。
沙芬酰胺在西班牙研究人群中表现出良好的安全性概况，尽管处方给有精神疾病的患者和标签外使用的情况比欧洲研究人群更为常见。在西班牙，当沙芬酰胺作为左旋多巴的唯一附加治疗药物（57.4%和 53.7%的患者）和从雷沙吉兰转换时（55.1%的患者），观察到 UPDRS 评分有临床意义的改善。研究期间，运动并发症从 83.2%减少到 63.3%。在任何亚组患者中均未发现安全性担忧增加，尽管认知障碍患者的不良反应频率略高。
本亚分析进一步支持沙芬酰胺作为治疗左旋多巴治疗患者不同亚组运动波动的安全有效的选择。然而，沙芬酰胺在认知障碍患者中应谨慎使用。
