DINOGMI, University of Genoa, Genova, Italy.
Sant Pau Hospital, Universitat Autònoma de Barcelona, CIBERNED, Barcelona, Spain.
J Parkinsons Dis. 2021;11(1):187-198. doi: 10.3233/JPD-202224.
Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson's disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency.
To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions.
The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions.
Of the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events 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 subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in ≥40% of patients, according to the criteria developed by Shulman et al.Conclusion:The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term.
氨磺必利调节多巴胺能和谷氨酸能系统，对帕金森病（PD）的运动和非运动症状均有积极影响。药物利用研究 SYNAPSES 旨在考察氨磺必利在常规临床实践中的应用，这与欧洲药品管理局的建议一致。
描述在现实环境中使用氨磺必利治疗 PD 患者的不良事件发生情况。
SYNAPSES 试验是一项观察性、欧洲、多中心、回顾性前瞻性队列研究。对患者进行了长达 12 个月的随访，对所有患者以及年龄>75 岁、有相关合并症和精神疾病的患者进行了分析。
在纳入的 1610 例患者中，12 个月后可评估的患者有 82.4%，其中 25.1%的患者年龄>75 岁，70.8%有相关合并症，42.4%有精神疾病。在观察期间，45.8%的患者出现了不良事件，27.7%的患者发生了药物不良反应，9.2%的患者发生了严重不良事件。不良事件与患者信息传单中已描述的内容一致。大多数为轻度或中度，且完全缓解，在患者亚组中未发现差异。根据 Shulman 等人制定的标准，≥40%的患者的 UPDRS 运动评分和 UPDRS 总分均有临床意义的改善。
SYNAPSES 研究证实了氨磺必利的良好安全性，即使在特殊患者群体中也是如此。运动并发症和运动评分得到改善，在长期内 UPDRS 量表的评分保持临床显著改善。
