Safety of opicapone use in Parkinson’s disease: review of literature and real-world safety data

Anuj Kumar Burakoti, Ram Kumar Roy, Harikesh Dubey
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Abstract

Parkinson's disease (PD) presents a significant global health concern with increasing prevalence and burden. This review article examines the safety data of drug Opicapone from literature and real-world sources of safety data, highlighting the need for vigilance over anti-parkinsonian drugs. For literature review, the PubMed database was mined which concluded that Opicapone, a selective COMT inhibitor for PD, demonstrated ADR like dyskinesia, nausea, vomiting, headache, and constipation where on the other hand real-world evidence showed no safety alerts or recalls initiated by regulatory authorities for Opicapone, but known risks like dyskinesia and hallucination were identified. However, clinical trial statistics revealed hypertension as the most probable ADR, alongside constipation, dizziness, dyskinesia, headache, somnolence, and hyperhidrosis. Whereas, unlisted events, such as somnolence, hyperhidrosis, pulmonary embolism, and abdominal pain, were also observed. Most ADRs belonged to the nervous system disorders and gastrointestinal disorders class which can be attributed to the pharmacological effect of Opicapone. It was concluded from this review that there is need for continuous safety vigilance for Opicapone use as despite the presence of well-structured safety guidance, new risks can emerge.
阿匹卡朋治疗帕金森病的安全性:文献回顾和现实世界的安全性数据
帕金森氏病(PD)是一个重要的全球卫生问题,其患病率和负担不断增加。这篇综述文章从文献和现实世界的安全数据来源中检查了药物Opicapone的安全性数据,强调了对抗帕金森药物保持警惕的必要性。文献回顾方面,我们从PubMed数据库中得出结论,Opicapone是一种选择性COMT抑制剂,用于帕金森病,存在不良反应,如运动障碍、恶心、呕吐、头痛和便秘,而另一方面,现实世界的证据显示,监管机构没有对Opicapone发出安全警告或召回,但已知的风险如运动障碍和幻觉被确定。然而,临床试验统计显示高血压是最可能的不良反应,除此之外还有便秘、头晕、运动障碍、头痛、嗜睡和多汗症。然而,未列出的事件,如嗜睡、多汗症、肺栓塞和腹痛,也被观察到。大多数不良反应属于神经系统疾病和胃肠道疾病,可归因于Opicapone的药理作用。从这一综述中得出的结论是,尽管存在结构良好的安全指导,但仍有必要对Opicapone的使用保持持续的安全警惕,因为新的风险可能会出现。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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