Chaudhuri K Ray, Bouchard Manon, Freire-Alvarez Eric, Pahwa Rajesh, Bergmann Lars, Gupta Resmi, Kukreja Pavnit, Shah Megha B, Isaacson Stuart H
Parkinson's Foundation Centre of Excellence, King's College Hospital, London, UK.
Parkinson's Centre of Excellence, King's College Hospital, London, Dubai, UAE.
Clin Park Relat Disord. 2025 Apr 26;12:100330. doi: 10.1016/j.prdoa.2025.100330. eCollection 2025.
Parkinson's disease (PD) non-motor symptom burden, including nocturia and sleep disturbances, worsens with disease progression. Continuous dopaminergic drug delivery with nocturnal infusion in PD demonstrated improvements in sleep and nocturia. Foslevodopa/foscarbidopa (LDp/CDp) provides 24-hour continuous drug delivery of levodopa/carbidopa (LD/CD) prodrugs via continuous subcutaneous infusion (CSCI).
Least-squares mean nocturia changes (measured via Parkinson's Disease Sleep Scale-2 item 8) in patients with PD from a randomized 12-week phase 3 trial of LDp/CDp CSCI versus oral LD/CD (NCT04380142) and a 52-week open-label LDp/CDp CSCI phase 3 trial (NCT03781167) were analyzed post hoc via mixed-effects regression and analysis of covariance. Correlation coefficients at baseline (BL) and in change from BL to week 12 or week 52 (Δ BL-wk 12 or Δ BL-wk 52) for nocturia and quality of life (QoL, measured as Parkinson's Disease Questionnaire [PDQ-39] Summary Index score) were calculated via Spearman's test.
This exploratory analysis demonstrated significant and sustained improvement in nocturia symptoms from BL with LDp/CDp treatment in both the randomized (to week 12; n = 44; nominal p ≤ 0.01) and open-label (to weeks 6, 13, 26, and 52; with n = 176, 149, 107, and 75, respectively; nominal p ≤ 0.001 for all) trials. Nocturia improvement was significantly greater in LDp/CDp- versus oral-treated patients (n = 59; nominal p ≤ 0.05). A significant positive correlation between nocturia and QoL was shown at BL and between Δ BL-wk 12 in the randomized trial (nominal p ≤ 0.05 for both), while open-label results showed no significant correlations.
LDp/CDp-treated patients with PD demonstrated significantly improved nocturia with 24-hour therapy, 12-week nocturia improvements were significantly greater than oral therapy, and patient-reported nocturia may correlate with QoL.
帕金森病（PD）的非运动症状负担，包括夜尿症和睡眠障碍，会随着疾病进展而加重。帕金森病患者夜间输注多巴胺能药物持续给药可改善睡眠和夜尿症。福司左旋多巴/福司卡比多巴（LDp/CDp）通过持续皮下输注（CSCI）提供左旋多巴/卡比多巴（LD/CD）前体药物的24小时持续给药。
对来自一项LDp/CDp CSCI与口服LD/CD的随机12周3期试验（NCT04380142）以及一项52周开放标签LDp/CDp CSCI 3期试验（NCT03781167）的PD患者，通过混合效应回归和协方差分析对夜尿症变化的最小二乘均值（通过帕金森病睡眠量表-2第8项测量）进行事后分析。通过Spearman检验计算夜尿症与生活质量（QoL，以帕金森病问卷[PDQ-39]总结指数评分衡量）在基线（BL）以及从BL到第12周或第52周变化（ΔBL-wk 12或ΔBL-wk 52）时的相关系数。
这项探索性分析表明，在随机试验（至第12周；n = 44；名义p≤0.01）和开放标签试验（至第6、13、26和52周；分别为n = 176、149、107和75；所有名义p≤0.001）中，LDp/CDp治疗均使夜尿症症状从BL开始有显著且持续的改善。LDp/CDp治疗组患者的夜尿症改善明显大于口服治疗组患者（n = 59；名义p≤0.05）。在随机试验中，BL时以及从BL到第12周的变化（ΔBL-wk 12）时，夜尿症与QoL之间显示出显著正相关（两者名义p≤0.05），而开放标签试验结果未显示出显著相关性。
接受LDp/CDp治疗的PD患者在24小时治疗后夜尿症有显著改善，12周时夜尿症改善明显大于口服治疗，且患者报告的夜尿症可能与QoL相关。
