伊斯拉地夫林对帕金森病左旋多巴剂量递增的影响：ISTRA ADJUST PD 研究：一项多中心、开放标签、随机、平行组对照研究。

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2024-04-01 Epub Date: 2024-01-16 DOI:10.1007/s40120-023-00574-6

Taku Hatano, Renpei Sengoku, Hiroshi Nagayama, Naotake Yanagisawa, Asako Yoritaka, Keisuke Suzuki, Noriko Nishikawa, Yohei Mukai, Kyoichi Nomura, Norihito Yoshida, Morinobu Seki, Miho Kawabe Matsukawa, Hiroo Terashi, Katsuo Kimura, Jun Tashiro, Shigeki Hirano, Hidetomo Murakami, Hideto Joki, Tsuyoshi Uchiyama, Hideki Shimura, Kotaro Ogaki, Jiro Fukae, Yoshio Tsuboi, Kazushi Takahashi, Toshimasa Yamamoto, Kenichi Kaida, Ryoko Ihara, Kazutomi Kanemaru, Osamu Kano

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引用次数: 0

摘要

简介左旋多巴剂量过大是帕金森病（PD）运动并发症的一个风险因素。伊司替福林（IST）可作为左旋多巴的辅助治疗药物，用于帕金森病患者的脱失发作，但其对左旋多巴剂量滴定的影响仍不清楚。本研究旨在探讨 IST 对左旋多巴剂量升级的影响：这是一项多中心、开放标签、随机、平行组对照研究（ISTRA ADJUST PD），在这项研究中，正在接受左旋多巴 300-400 毫克/天治疗的帕金森病患者（n = 114）被随机分配接受 IST 或不接受 IST（对照组）治疗。左旋多巴剂量根据临床严重程度递增。主要终点是累积额外左旋多巴剂量，次要终点是症状评分量表的变化、由可穿戴设备确定的运动活动以及安全性结果：结果：IST组在37周内的累积额外左旋多巴剂量和36周内的剂量增加均显著低于对照组（均为P 结论：IST治疗减少了左旋多巴的剂量，并提高了左旋多巴的疗效：IST 治疗减少了帕金森病患者左旋多巴剂量的增加，从而减少了左旋多巴的累积用量。与增加左旋多巴剂量相比，辅助 IST 可更客观地改善帕金森病患者的运动功能：试验注册：日本临床试验注册中心：jRCTs031180248。

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Impact of Istradefylline on Levodopa Dose Escalation in Parkinson's Disease: ISTRA ADJUST PD Study, a Multicenter, Open-Label, Randomized, Parallel-Group Controlled Study.

Introduction: A higher levodopa dose is a risk factor for motor complications in Parkinson's disease (PD). Istradefylline (IST) is used as adjunctive treatment to levodopa in PD patients with off episodes, but its impact on levodopa dose titration remains unclear. The objective of this study was to investigate the effect of IST on levodopa dose escalation in PD patients with wearing-off.

Methods: This was a multicenter, open-label, randomized, parallel-group controlled study (ISTRA ADJUST PD) in which PD patients experiencing wearing-off (n = 114) who were receiving levodopa 300-400 mg/day were randomized to receive IST or no IST (control). Levodopa dose was escalated according to clinical severity. The primary endpoint was cumulative additional levodopa dose, and secondary endpoints were changes in symptom rating scales, motor activity determined by a wearable device, and safety outcomes.

Results: The cumulative additional levodopa dose throughout 37 weeks and dose increase over 36 weeks were significantly lower in the IST group than in the control group (both p < 0.0001). The Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I and device-evaluated motor activities improved significantly from baseline to 36 weeks in the IST group only (all p < 0.05). Other secondary endpoints were comparable between the groups. Adverse drug reactions (ADRs) occurred in 28.8% and 13.2% of patients in the IST and control groups, respectively, with no serious ADRs in either group.

Conclusion: IST treatment reduced levodopa dose escalation in PD patients, resulting in less cumulative levodopa use. Adjunctive IST may improve motor function more objectively than increased levodopa dose in patients with PD.

Trial registration: Japan Registry of Clinical Trials: jRCTs031180248.

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

期刊介绍： Aims and Scope Neurology and Therapy aims to provide reliable and inclusive, rapid publication for all therapy related research for neurological indications, supporting the timely dissemination of research with a global reach, to help advance scientific discovery and support clinical practice. Neurology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of neurological and psychiatric therapies, (also covering surgery and devices). Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial designs, communications and letters. 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