Boyd James T, Zadikoff Cindy, Benesh Janet A, Zamudio Jorge, Robieson Weining Z, Kukreja Pavnit, Yokoyama Masayuki, Siddiqui Mustafa S
Department of Neurological Sciences, University of Vermont Larner College of Medicine, 1 South Prospect Street, UHC - Arnold 2, Burlington, VT 05401, USA.
AbbVie, Inc., 1 Waukegan Rd, North Chicago, IL 60064, USA.
Clin Park Relat Disord. 2019 Dec 11;2:25-34. doi: 10.1016/j.prdoa.2019.12.001. eCollection 2020.
As Parkinson's disease (PD) progresses, the number/frequency of PD medications tend to increase, which is correlated with decreased patient compliance and suboptimal control of PD symptoms. We investigated efficacy and safety of levodopa-carbidopa intestinal gel (LCIG) daytime monotherapy (with or without nighttime oral levodopa-carbidopa) compared with polytherapy (LCIG with ≥1 adjunctive PD therapy) in advanced PD patients.
This post hoc descriptive study compared LCIG stable daytime monotherapy with LCIG stable polytherapy in all six phase 3/3b open-label studies from both US and international sites; because of study design variability, pooling data for comparison was not appropriate. Efficacy assessments included PD diary data (mean change from baseline in "Off" time and "On" time with or without troublesome dyskinesia), mean Unified PD Rating Scale scores (Parts II and III), and 39-item Parkinson's Disease Questionnaire (PDQ-39) summary index. Adverse events were also assessed.
Overall, LCIG daytime monotherapy and polytherapy demonstrated similar efficacy/safety profiles in advanced PD patients, regardless of treatment duration or population. LCIG monotherapy vs. polytherapy groups experienced similar mean decreases in "Off" time (4.6 vs. 4.1 h/day) and similar increases in "On" time without troublesome dyskinesia (4.6 vs. 4.1 h/day). In most studies, PDQ-39 summary index scores were reduced from baseline by ≥5 points, regardless of patient population or study duration. Adverse events not related to the procedure/device were similar in both groups.
Our data suggest that, for appropriate patients, LCIG monotherapy can provide a more simplified treatment option with similar efficacy and safety.
随着帕金森病（PD）病情进展，PD药物的数量/服用频率往往会增加，这与患者依从性降低及PD症状控制欠佳相关。我们比较了左旋多巴-卡比多巴肠凝胶（LCIG）日间单一疗法（联合或不联合夜间口服左旋多巴-卡比多巴）与多药联合疗法（LCIG联合≥1种辅助PD治疗药物）在晚期PD患者中的疗效和安全性。
这项事后描述性研究在美国和国际多个研究点开展的6项3期/3b期开放标签研究中，比较了LCIG稳定的日间单一疗法与LCIG稳定的多药联合疗法；由于研究设计存在差异，合并数据进行比较并不合适。疗效评估包括PD日记数据（“关”期时间和“开”期时间较基线的平均变化，“开”期有无麻烦的异动症）、统一PD评定量表平均得分（第二部分和第三部分）以及39项帕金森病问卷（PDQ-39）汇总指数。同时对不良事件进行评估。
总体而言，无论治疗持续时间或研究人群如何，LCIG日间单一疗法和多药联合疗法在晚期PD患者中显示出相似的疗效/安全性。LCIG单一疗法组与多药联合疗法组的“关”期时间平均减少量相似（分别为4.6小时/天和4.1小时/天），“开”期且无麻烦异动症的时间平均增加量也相似（分别为4.6小时/天和4.1小时/天）。在大多数研究中，无论患者人群或研究持续时间如何，PDQ-39汇总指数得分较基线均降低了≥5分。两组中与手术/器械无关的不良事件相似。
我们的数据表明，对于合适的患者，LCIG单一疗法可提供一种疗效和安全性相似但更为简化的治疗选择。
