Edmond J Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada.
Krembil Research Institute, Toronto, Ontario, Canada.
Mov Disord. 2021 Aug;36(8):1853-1862. doi: 10.1002/mds.28596. Epub 2021 Apr 28.
Levodopa-carbidopa intestinal gel (LCIG) is administered directly to the small intestine of patients with advanced Parkinson's disease (APD) to help maintain stable plasma levodopa levels.
The objective of this study was to investigate the effect of LCIG in reducing polypharmacy for the treatment of APD.
The COmedication Study assessing Mono- and cOmbination therapy with levodopa-carbidopa inteStinal gel (COSMOS) is a large, real-world, multinational observational study investigating comedication use with LCIG. All enrolled patients had used LCIG for ≥12 months and data were collected cross-sectionally (study visit) and retrospectively. The primary endpoint was the percentage of patients using LCIG as monotherapy (without add-on PD medications) at initiation and at 3, 6, 9, and 12 months thereafter.
Overall, 409 patients were enrolled from 14 countries and were treated with LCIG for a mean of 35.8 ± 23.2 months. A total of 15.2% of patients initiated LCIG as monotherapy and 31.7% were receiving monotherapy at 12 months after initiation. The mean duration of LCIG monotherapy was 39.3 ± 25.6 months. Use of add-on medications decreased over time with all LCIG regimens. From LCIG initiation to the patient visit, mean off time decreased by 3.8, 4.6, and 3.9 hours/day for LCIG monotherapy, LCIG daytime monotherapy, and LCIG polytherapy groups, respectively, while duration of dyskinesia decreased by 1.7, 2.0, and 1.9 hours/day, respectively. Adverse events likely related to study treatment occurred in 112 patients (27.4%) during LCIG treatment.
LCIG is an effective long-term monotherapy option with a positive risk-benefit profile and contributes to reduced polypharmacy for patients with APD. © 2021 The AbbVie Inc. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
左旋多巴-卡比多巴肠凝胶（LCIG）直接施用于晚期帕金森病（APD）患者的小肠，以帮助维持稳定的血浆左旋多巴水平。
本研究旨在探讨 LCIG 对减少 APD 治疗中的多药治疗的影响。
COmedication Study assessing Mono- and cOmbination therapy with levodopa-carbidopa inteStinal gel（COSMOS）是一项大型、真实世界、多国观察性研究，研究了 LCIG 联合用药的使用情况。所有入组患者均使用 LCIG 治疗≥12 个月，数据采用横断面（研究访视）和回顾性收集。主要终点是起始时和起始后 3、6、9 和 12 个月时使用 LCIG 作为单药治疗（无附加 PD 药物）的患者比例。
总体而言，来自 14 个国家的 409 名患者入组，并接受 LCIG 治疗，平均 35.8±23.2 个月。15.2%的患者起始时接受 LCIG 单药治疗，12 个月后有 31.7%的患者接受单药治疗。LCIG 单药治疗的平均持续时间为 39.3±25.6 个月。随着时间的推移，所有 LCIG 方案的附加药物使用均减少。从 LCIG 起始到患者就诊，LCIG 单药治疗、LCIG 白天单药治疗和 LCIG 多药治疗组的平均无运动时间分别减少 3.8、4.6 和 3.9 小时/天，而运动障碍持续时间分别减少 1.7、2.0 和 1.9 小时/天。112 名患者（27.4%）在 LCIG 治疗期间发生了可能与研究治疗相关的不良事件。
LCIG 是一种有效的长期单药治疗选择，具有积极的风险效益比，并有助于减少 APD 患者的多药治疗。© 2021 艾伯维公司。由 Wiley Periodicals LLC 代表国际帕金森病和运动障碍学会出版的《运动障碍》。
