Rocha José-Francisco, Ebersbach Georg, Lees Andrew, Tolosa Eduardo, Ferreira Joaquim J, Poewe Werner, Rascol Olivier, Stocchi Fabrizio, Antonini Angelo, Magalhães Diogo, Gama Helena, Soares-da-Silva Patrício
BIAL - Portela & Ca, S.A., Coronado, Portugal.
Movement Disorders Clinic, Beelitz-Heilstätten, Germany.
Front Neurol. 2021 Nov 5;12:754016. doi: 10.3389/fneur.2021.754016. eCollection 2021.
Opicapone (OPC) was efficacious in reducing OFF-time in two pivotal trials in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations (BIPARK-I and -II). analyses of these trials evaluated the efficacy of OPC following pre-defined segmentation of the wide spectrum of motor fluctuations in PD. Data from matching treatment arms in BIPARK-I and -II were combined for the placebo (PLC) and OPC 50-mg groups, and exploratory analyses were performed to investigate the efficacy of OPC 50 mg vs. PLC in subgroups of patients who were in "earlier" vs. "later" stages of both their disease course (e.g., duration of PD <6 years vs. ≥6 years) and levodopa treatment pathway (e.g., number of daily levodopa intakes <4 vs. ≥4). Efficacy variables included changes from baseline in absolute OFF-time and total ON-time. The Full Analysis Set included 517 patients (PLC, = 255; OPC 50 mg, = 262). OPC 50 mg was significantly more effective than PLC in reducing OFF-time and increasing ON-time in the majority of subgroup analyses ( < 0.05). Moreover, patients in "earlier" stages of both their disease course and levodopa treatment pathway experienced numerically greater efficacy when using OPC 50 mg, in comparison with those in "later" stages. OPC 50 mg was efficacious over the whole trajectory of motor fluctuation evolution in PD patients. There was also a signal for enhanced efficacy in patients who were earlier vs. later in their disease course and levodopa treatment pathway.
奥匹卡朋（OPC）在两项针对帕金森病（PD）和剂末运动波动患者的关键试验（BIPARK-I和-II）中，在减少“关”期时间方面疗效显著。这些试验的分析评估了OPC在对PD广泛运动波动进行预定义细分后的疗效。将BIPARK-I和-II中匹配治疗组的安慰剂（PLC）和OPC 50 mg组的数据合并，并进行探索性分析，以研究OPC 50 mg与PLC在疾病病程（如PD病程<6年与≥6年）和左旋多巴治疗路径（如每日左旋多巴摄入量<4次与≥4次）处于“早期”与“晚期”阶段的患者亚组中的疗效。疗效变量包括绝对“关”期时间和总“开”期时间相对于基线的变化。全分析集包括517名患者（PLC组，n = 255；OPC 50 mg组，n = 262）。在大多数亚组分析中，OPC 50 mg在减少“关”期时间和增加“开”期时间方面比PLC显著更有效（P<0.05）。此外，与处于“晚期”阶段的患者相比，疾病病程和左旋多巴治疗路径均处于“早期”阶段的患者使用OPC 50 mg时在数值上疗效更佳。OPC 50 mg在PD患者运动波动演变的整个过程中均有效。在疾病病程和左旋多巴治疗路径处于早期与晚期的患者中，也有疗效增强的迹象。
