DataSheet1_Adverse event profiles of adjuvant treatment with opicapone in Parkinson’s disease: A systematic review and meta-analysis.PDF

Background: Opicapone, a novel third-generation catechol-O-methyltransferase inhibitor, has demonstrated efficacy in Parkinson’s Disease (PD) patients with end-of-dose motor fluctuations.
Objective: This study aimed to compare the short-term (<6 months) and long-term (≥6 months) tolerability of opicapone adjuvant treatment in PD patients.
Method: Electronic databases including PubMed, Embase, Web of Science and Cochrane library were searched for randomized controlled trials (RCTs) and observational studies. The end points included any treatment-related adverse events (TEAEs), serious TEAEs (SAEs) and treatment discontinuation. A random-effects model was used to generate overall incidences of TEAE.
Results: Three RCTs, three RCT extension studies and three open-label studies involving 2177 PD patients were evaluated. In the short-term studies, there were reports of TEAEs with an incidence of ≥5% in individuals treated with opicapone 50 mg, including dyskinesia (14.1%), elevated blood creatine phosphokinase levels (8.0%) and urinary tract infection (6.0%). Any TEAEs, SAEs and treatment discontinuation all occurred at rates of 62.9%, 4.8% and 9.3%, respectively. TEAEs with opicapone 50 mg that were reported by more than 5% of patients in long-term studies included dyskinesia (16.1%), dry mouth (12.1%), medication effect decreased (12.1%), PD exacerbated (7.8%), blood creatine phosphokinase level raised (7.4%), nausea (6.1%) and insomnia (5.1%). The incidence of any TEAEs, SAEs and treatment discontinuation were, correspondingly, 73.2%, 8.7% and 8.4%.
Conclusion: These studies demonstrated that opicapone was generally well-tolerated and had a low risk of adverse events, suggesting that it could be a valuable therapeutic choice for people with PD.

研究背景：奥匹卡朋（opicapone）是一种新型第三代儿茶酚-O-甲基转移酶抑制剂（catechol-O-methyltransferase inhibitor），在伴剂末运动波动的帕金森病（Parkinson’s Disease, PD）患者中已展现出治疗疗效。
研究目的：本研究旨在比较奥匹卡朋辅助治疗帕金森病患者的短期（<6个月）与长期（≥6个月）耐受性。
研究方法：检索PubMed、Embase、Web of Science及Cochrane图书馆等电子数据库，筛选随机对照试验（randomized controlled trials, RCTs）与观察性研究。研究终点涵盖任意治疗相关不良事件（treatment-related adverse events, TEAEs）、严重治疗相关不良事件（serious TEAEs, SAEs）以及治疗中止情况。采用随机效应模型计算治疗相关不良事件的总体发生率。
研究结果：共纳入3项随机对照试验、3项随机对照试验延伸研究及3项开放标签研究，涉及2177名帕金森病患者。在短期研究中，接受50mg奥匹卡朋治疗的患者中，发生率≥5%的治疗相关不良事件包括运动障碍（14.1%）、血肌酸磷酸激酶水平升高（8.0%）及尿路感染（6.0%）；任意治疗相关不良事件、严重治疗相关不良事件及治疗中止的发生率分别为62.9%、4.8%与9.3%。在长期研究中，接受50mg奥匹卡朋治疗且发生率超过5%的治疗相关不良事件包括运动障碍（16.1%）、口干（12.1%）、药效减退（12.1%）、帕金森病病情加重（7.8%）、血肌酸磷酸激酶水平升高（7.4%）、恶心（6.1%）及失眠（5.1%）；任意治疗相关不良事件、严重治疗相关不良事件及治疗中止的发生率分别为73.2%、8.7%与8.4%。
研究结论：上述研究结果表明，奥匹卡朋总体耐受性良好，不良事件风险较低，提示其可作为帕金森病患者极具价值的治疗选择。