Xie Luwen, Qi Xiaoyi, Wang Xuan, He Bing, Wang Yu, Zhang Wei, Yu Zehui, Deng Mingming, Liang Sicheng, Lü Muhan
Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.
Department of Dermatology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.
Front Pharmacol. 2022 Nov 24;13:1042992. doi: 10.3389/fphar.2022.1042992. eCollection 2022.
Opicapone, a novel third-generation catechol-O-methyltransferase inhibitor, has demonstrated efficacy in Parkinson's Disease (PD) patients with end-of-dose motor fluctuations. This study aimed to compare the short-term (<6 months) and long-term (≥6 months) tolerability of opicapone adjuvant treatment in PD patients. 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. 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%. 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.
奥匹卡朋是一种新型的第三代儿茶酚-O-甲基转移酶抑制剂，已在帕金森病（PD）伴剂末运动波动的患者中显示出疗效。本研究旨在比较奥匹卡朋辅助治疗在PD患者中的短期（<6个月）和长期（≥6个月）耐受性。检索了包括PubMed、Embase、Web of Science和Cochrane图书馆在内的电子数据库，以查找随机对照试验（RCT）和观察性研究。终点包括任何与治疗相关的不良事件（TEAE）、严重TEAE（SAE）和治疗中断。采用随机效应模型生成TEAE的总体发生率。评估了涉及2177例PD患者的三项RCT、三项RCT扩展研究和三项开放标签研究。在短期研究中，有报告称接受50mg奥匹卡朋治疗的个体中TEAE发生率≥5%，包括运动障碍（14.1%）、血肌酸磷酸激酶水平升高（8.0%）和尿路感染（6.0%）。任何TEAE、SAE和治疗中断的发生率分别为62.9%、4.8%和9.3%。长期研究中，超过5%的患者报告的50mg奥匹卡朋相关TEAE包括运动障碍（16.1%）、口干（12.1%）、药物效果降低（12.1%）、PD加重（7.8%）、血肌酸磷酸激酶水平升高（7.4%）、恶心（6.1%）和失眠（5.1%）。相应地，任何TEAE、SAE和治疗中断的发生率分别为73.2%、8.7%和8.4%。这些研究表明，奥匹卡朋总体耐受性良好，不良事件风险较低，表明它可能是PD患者的一种有价值的治疗选择。
