Department of Neurology, AZ St-Jan Brugge-Oostende AV, Campus Brugge, Brugge, Belgium.
Department of Neurology, Ghent University Hospital, Ghent, Belgium.
Acta Neurol Belg. 2023 Jun;123(3):939-947. doi: 10.1007/s13760-022-02100-1. Epub 2022 Oct 6.
Safinamide is a recent multimodal antiparkinsonian drug that inhibits monoamine oxidase B and modulates the glutamatergic system with positive effects on motor and nonmotor symptoms of Parkinson's disease (PD). This post-hoc analysis of the European SYNAPSES study provides first-time data on the use of safinamide in routine clinical practice in Belgium.
To describe the efficacy and safety of safinamide in Belgian PD patients in real-life conditions.
Post-hoc analysis of the Belgian cohort from the European SYNAPSES trial, which was an observational, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months. Analyses were performed in the overall population and according to different criteria such as the age limit (> 75 years), presence or absence of relevant comorbidities, presence or absence of psychiatric conditions such as depression and anxiety, patients on levodopa monotherapy or levodopa in combination with other treatments, patients on rasagiline before inclusion or not.
Of the 172 patients included, 29.2% were > 75 years, 58.9% had relevant comorbidities and 32.7% had psychiatric conditions. Almost all the patients reported motor (98.8%) or non-motor (86.3%) symptoms. During the study, 36.3% of patients reported drug-related reactions. The adverse drug reactions were those already described in the patients' information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroups of patients. Almost 35% of the patients demonstrated a clinically significant improvement in the UPDRS and 50% of the patients with wearing-off at baseline, did not report wearing-off anymore after one year of treatment. Patients under levodopa monotherapy compared to patients receiving levodopa combined with other antiparkinsonian treatments benefit more from safinamide treatment. Patients switched from rasagiline to safinamide seemed also to benefit more from safinamide treatment.
The study confirms the excellent safety and efficacy profile of safinamide, particularly in more vulnerable groups of patients such as the elderly and patients with significant comorbidities or psychiatric conditions such as depression or anxiety.
沙芬酰胺是一种新型的多模式抗帕金森病药物，它可以抑制单胺氧化酶 B，并通过调节谷氨酸能系统对帕金森病的运动和非运动症状产生积极影响。本研究对欧洲 SYNAPSES 研究进行了事后分析，首次提供了沙芬酰胺在比利时常规临床实践中的使用数据。
描述沙芬酰胺在比利时帕金森病患者中的疗效和安全性。
对欧洲 SYNAPSES 试验中的比利时队列进行了事后分析，该试验是一项观察性、多中心、回顾性前瞻性队列研究。患者的随访时间为 12 个月。分析在总体人群中进行，并根据不同标准进行分析，如年龄限制（>75 岁）、是否存在相关合并症、是否存在抑郁和焦虑等精神疾病、是否单独使用左旋多巴或与其他治疗联合使用、是否在纳入前使用雷沙吉兰。
在纳入的 172 名患者中，29.2%的患者年龄>75 岁，58.9%的患者有相关合并症，32.7%的患者有精神疾病。几乎所有的患者都报告了运动（98.8%）或非运动（86.3%）症状。在研究期间，36.3%的患者报告了药物相关反应。这些不良反应是患者用药须知中已描述的不良反应。大多数不良反应为轻度或中度，完全缓解，且在不同亚组患者之间未检测到差异。近 35%的患者在 UPDRS 中表现出明显的临床改善，50%的基线时有“开-关”现象的患者在一年的治疗后不再报告“开-关”现象。与接受左旋多巴联合其他抗帕金森病治疗的患者相比，单独接受左旋多巴治疗的患者从沙芬酰胺治疗中获益更多。从雷沙吉兰转为沙芬酰胺治疗的患者似乎也从沙芬酰胺治疗中获益更多。
该研究证实了沙芬酰胺具有良好的安全性和疗效，特别是在更脆弱的患者群体中，如老年人和有显著合并症或抑郁、焦虑等精神疾病的患者。
