Stocchi Fabrizio, Antonini Angelo, Berg Daniela, Bergmans Bruno, Jost Wolfgang, Katzenschlager Regina, Kulisevsky Jaime, Odin Per, Valldeoriola Francesc, Ray Chaudhuri K
Department of Neurology, University and IRCCS San Raffaele Pisana, Rome, Italy.
Parkinson and Movement Disorders Unit, Center for Rare Neurological Diseases (ERN-RND), Tübingen, Germany.
NPJ Parkinsons Dis. 2022 Feb 21;8(1):17. doi: 10.1038/s41531-022-00277-z.
Safinamide is a highly selective, reversible MAO B-inhibitor recently marketed in European and North American countries. To better define clinical indications regarding motor and non-motor symptoms, targeted population and safety of this compound, ten movement disorders specialists, experts in their field, convened and developed a panel of statements on: the role of glutamate in Parkinson's disease, introduction to fluctuations, efficacy of safinamide on motor symptoms, motor complications and non-motor symptoms, quality of life, safety of safinamide and target population for use. Strong consensus was reached for all the statements on the efficacy of safinamide on motor symptoms, motor fluctuations, quality of life and safety. Among non-motor symptoms, a positive consensus was reached for the symptoms sleep/fatigue, mood, and pain while there was a lack of consensus for the statements regarding the efficacy of safinamide in improving cognition, urinary and sexual functions. The statement on orthostatic hypotension obtained a negative consensus. The consistent and large agreement reached in this Delphi panel perfectly reflects the perception of efficacy, safety and tolerability of safinamide as evident from pivotal trials and clinical practice and shows how these findings may guide movement disorders specialists in their clinical therapeutic approach. The impact of non-motor symptoms in PD is considerable, and management remains an unmet need. In this context, the ability of safinamide to impact some non-motor symptoms may represent the most promising and distinctive feature of this compound and deserves further investigations.
沙芬酰胺是一种高选择性、可逆的单胺氧化酶B抑制剂，最近在欧洲和北美国家上市。为了更好地明确该化合物在运动和非运动症状、目标人群及安全性方面的临床适应症，十位该领域的运动障碍专家齐聚并制定了一组关于以下方面的声明：谷氨酸在帕金森病中的作用、波动的介绍、沙芬酰胺对运动症状的疗效、运动并发症和非运动症状、生活质量、沙芬酰胺的安全性以及适用的目标人群。对于沙芬酰胺在运动症状、运动波动、生活质量和安全性方面的疗效，所有声明均达成了强烈共识。在非运动症状方面，对于睡眠/疲劳、情绪和疼痛症状达成了积极共识，而对于沙芬酰胺在改善认知、泌尿和性功能方面的疗效声明则未达成共识。关于体位性低血压的声明获得了负面共识。在这个德尔菲小组中达成的一致且广泛的共识完美地反映了从关键试验和临床实践中所体现出的对沙芬酰胺疗效、安全性和耐受性的认识，并展示了这些发现如何指导运动障碍专家的临床治疗方法。帕金森病中非运动症状的影响相当大，其管理仍然是一项未满足的需求。在这种背景下，沙芬酰胺影响某些非运动症状的能力可能代表了该化合物最有前景和独特的特征，值得进一步研究。
