Castro Caldas Ana, Teodoro Tiago, Ferreira Joaquim J
a Neurology Service, Department of Neurosciences , Hospital de Santa Maria , Lisbon , Portugal.
b Neurology Department , Instituto de Medicina Molecular , Lisbon , Portugal.
Expert Opin Drug Saf. 2018 Mar;17(3):331-337. doi: 10.1080/14740338.2018.1433659.
Opicapone is a novel, third generation COMT inhibitor approved for the treatment of Parkinson's disease. Safety and tolerability data is critical to determine the benefit-harm balance and anticipate therapeutic adherence. Areas covered: This review evaluates the tolerability and safety profile of opicapone. These data were extracted from all published clinical trials, including preclinical, phase I, phase II and phase III studies as well as postmarketing data. Opicapone was safe and well tolerated, with frequencies of treatment-emergent adverse events similar to placebo. Expert opinion: Opicapone have shown a good safety and tolerability profile. This adds to its proven efficacy and convenient once-daily administration, supporting a role of opicapone as a first-line therapy for motor complications in Parkinson's disease patients.
奥匹卡朋是一种新型的第三代儿茶酚-O-甲基转移酶（COMT）抑制剂，已被批准用于治疗帕金森病。安全性和耐受性数据对于确定利弊平衡以及预测治疗依从性至关重要。涵盖领域：本综述评估了奥匹卡朋的耐受性和安全性概况。这些数据来自所有已发表的临床试验，包括临床前、I期、II期和III期研究以及上市后数据。奥匹卡朋安全且耐受性良好，治疗中出现的不良事件发生率与安慰剂相似。专家意见：奥匹卡朋已显示出良好的安全性和耐受性概况。这进一步证明了其已证实的疗效和方便的每日一次给药方式，支持奥匹卡朋作为帕金森病患者运动并发症一线治疗药物的作用。
