Improvement in Quality of Life and Non-Motor Symptoms Associated With OFF Episodes in People With Parkinson's Disease Treated With Inhaled Levodopa

IF 4.3 2区 医学 Q1 CLINICAL NEUROLOGY
Diego Santos García, María Cerdán Sánchez, Rosa Yáñez Baña, Iria Cabo, Maria Icíar Cimas Hernando
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Abstract

Background

CVT-301 (Inbrija) has demonstrated its effectiveness in treating OFF periods in people with Parkinson's disease (PwP). However, its effect on non-motor symptoms (NMS) and quality of life has not been researched yet. Our aim was to analyze the change observed in health-related quality of life (HRQoL) and, as a secondary exploratory analysis, NMS associated with OFF episodes in PwP treated with CVT-301.

Methods

INLEVO-LIFE PD (an open-label study of the effect of INhaled LEVOdopa on quality of LIFE and non-motor symptoms in Parkinson's Disease) is a prospective open-label study conducted in five centers in Spain. The change from baseline (V0) to the end of the observational period (12 ± 2 weeks) (V12w) in the 39-item Parkinson's Disease Quality of Life Questionnaire (PDQ-39) total score was the primary efficacy measure.

Results

Forty PD patients (age 62.3 ± 9.2 years; 55% males) were included between March/2024 and November/2025. At 12 weeks, 34 patients were using CVT-301 and completed the follow-up (85%). The PDQ39 total score decreased from 43.6 ± 24.2 at V0 to 31.4 ± 20.6 at V12w (p < 0.0001). A significant decrease was observed in the mean score of 4 domains of the PDQ39. NMS burden was reduced at v12w from the OFF state to 30, 60, and 90 min after using CVT-301 (p < 0.0001). Mean daily OFF time decreased by 1.6 ± 1.9 h (p < 0.0001). Adverse events related to CVT-301 were reported in 35% of the patients.

Conclusion

HRQoL and NMS associated with OFF episodes improved in PwP after 12 weeks using CVT-301.

吸入左旋多巴治疗帕金森病患者OFF发作相关的生活质量和非运动症状的改善
背景:CVT-301 (Inbrija)已证明其治疗帕金森病(PwP)患者OFF期的有效性。然而,其对非运动症状(NMS)和生活质量的影响尚未研究。我们的目的是分析观察到的与健康相关的生活质量(HRQoL)的变化,并作为二次探索性分析,NMS与使用CVT-301治疗的PwP的OFF发作相关。方法:INLEVO-LIFE PD(一项关于吸入左旋多巴对帕金森病患者生活质量和非运动症状影响的开放标签研究)是一项在西班牙五个中心进行的前瞻性开放标签研究。39项帕金森病生活质量问卷(PDQ-39)总分从基线(V0)到观察期结束(12±2周)(V12w)的变化是主要的疗效衡量指标。结果:2024年3月至2025年11月共纳入PD患者40例(年龄62.3±9.2岁,男性55%)。12周时,34例患者使用CVT-301并完成随访(85%)。PDQ39总分从V0时的43.6±24.2降至V12w时的31.4±20.6 (p)。结论:使用CVT-301治疗12周后,PwP患者HRQoL和与OFF发作相关的NMS得到改善。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
European Journal of Neurology
European Journal of Neurology 医学-临床神经学
CiteScore
9.70
自引率
2.00%
发文量
418
审稿时长
1 months
期刊介绍: The European Journal of Neurology is the official journal of the European Academy of Neurology and covers all areas of clinical and basic research in neurology, including pre-clinical research of immediate translational value for new potential treatments. Emphasis is placed on major diseases of large clinical and socio-economic importance (dementia, stroke, epilepsy, headache, multiple sclerosis, movement disorders, and infectious diseases).
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