Abstract:
Safinamide is a new add-on drug to levodopa for the treatment of Parkinson\'s disease (PD) with motor fluctuations. Due to the recent incorporation of safinamide into routine clinical practice, no post-authorisation phase IV studies on the safety of safinamide have been conducted to date. This study provides clinical management guidelines for safinamide based on the opinion of a group of experts in movement disorders. This project was developed in 2 phases: 16 local meetings in phase 1 and a national meeting in phase 2. The meetings followed a pre-established agenda. The present clinical practice guidelines are based on the main conclusions reached during the national meeting. The group concluded that safinamide is effective in reducing motor and non-motor fluctuations. PD patients with mild-to-moderate fluctuations benefit most from treatment, although the drug may also improve the clinical status of patients with advanced PD. The dose of other dopaminergic drugs may be reduced after introducing safinamide, which would contribute to reducing such adverse reactions as impulse control disorder. At doses higher than those usually prescribed, safinamide may also improve dyskinesia. The experts agreed that safinamide is well tolerated and causes few adverse reactions when compared with placebo.
摘要:
Safinamide是左旋多巴的一种新型附加药物,用于治疗具有运动波动的帕金森病(PD)。由于沙芬酰胺最近被纳入常规临床实践,迄今为止,尚未进行关于沙芬酰胺安全性的授权后IV期研究.本研究根据一组运动障碍专家的意见,提供了safinamide的临床管理指南。该项目分两个阶段进行:第一阶段的16次地方会议和第二阶段的一次全国会议。会议遵循了预先确定的议程。目前的临床实践指南是基于全国会议期间得出的主要结论。该小组得出结论,沙芬酰胺可有效减少运动和非运动波动。轻度至中度波动的PD患者从治疗中获益最多,尽管该药物也可能改善晚期PD患者的临床状况。其他多巴胺能药物的剂量可能会减少后引入safinamide,这将有助于减少冲动控制障碍等不良反应。在高于通常处方的剂量下,safinamide也可以改善运动障碍。专家们一致认为,与安慰剂相比,沙芬酰胺耐受性良好,不良反应少。