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阿扑吗啡酮:治疗帕金森病的药物评价。

Opicapone: A Review in Parkinson's Disease.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

CNS Drugs. 2021 Jan;35(1):121-131. doi: 10.1007/s40263-020-00778-6. Epub 2021 Jan 11.

Abstract

Oral opicapone (Ongentys), a potent third-generation, peripheral catechol-O-methyltransferase (COMT) inhibitor, is approved as adjunctive therapy to preparations of levodopa/dopa-decarboxylase inhibitor (L-dopa/DDCI) in adults with Parkinson's disease (PD) and end-of dose (EoD) motor fluctuations. In pivotal global trials (BIPARK 1 and BIPARK 2; 14-15 weeks' duration), open-label extensions (OLEs) of BIPARK, and in the real-world setting (OPTIPARK; 3-6 months), opicapone 50 mg once daily was an effective and generally well tolerated adjunctive therapy to L-dopa/DDCI plus other PD therapy in adults with PD and EoD motor fluctuations. Adjunctive opicapone provided better efficacy than placebo for improvements in ON- and OFF-state time and fulfilled noninferiority to adjunctive entacapone for improvements in OFF time in BIPARK 1. These beneficial effects of adjunctive opicapone on motor fluctuations were maintained during 1 year of treatment in OLE studies. Given its efficacy and safety profile, adjunctive opicapone remains an important option in the management of adults with PD and EoD motor fluctuations who cannot be stabilized on preparations of L-dopa/DDCI.

摘要

口服恩他卡朋(Ongentys),一种强效的第三代外周儿茶酚-O-甲基转移酶(COMT)抑制剂,被批准作为左旋多巴/多巴脱羧酶抑制剂(L-dopa/DDCI)的附加疗法,用于治疗帕金森病(PD)和末剂(EoD)运动波动的成人患者。在关键性全球试验(BIPARK 1 和 BIPARK 2;持续 14-15 周)、BIPARK 的开放标签扩展(OLE)以及真实世界环境(OPTIPARK;持续 3-6 个月)中,每日一次口服 50mg 的恩他卡朋是一种有效的且通常耐受性良好的附加疗法,可与左旋多巴/DDCI 加其他 PD 疗法联合用于有 EoD 运动波动的 PD 成人患者。与安慰剂相比,恩他卡朋附加疗法可显著改善 ON 和 OFF 状态时间,在 BIPARK 1 中也显著改善 OFF 时间,与恩他卡朋附加疗法相比具有非劣效性。在 OLE 研究中,恩他卡朋附加疗法对运动波动的有益作用在 1 年的治疗期间得以维持。鉴于其疗效和安全性特征,对于不能用左旋多巴/DDCI 制剂稳定的 EoD 运动波动的 PD 成人患者,恩他卡朋附加疗法仍然是一种重要的治疗选择。

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