Real-world implementation of continuous subcutaneous foslevodopa/foscarbidopa in advanced Parkinson's disease: first clinical experience from the Middle East.
Аннотация
BACKGROUND
Continuous subcutaneous foslevodopa/foscarbidopa (FLD/FCD) is the first 24-h levodopa-based subcutaneous infusion therapy for advanced Parkinson's disease (PD). Real-world data from the Middle East region are absent.
OBJECTIVES
To report the first Middle Eastern clinical experience with foslevodopa/foscarbidopa, evaluating motor and non-motor outcomes, safety profile, and treatment continuation rates in routine clinical practice.
DESIGN
Retrospective, single-center, observational cohort study.
METHODS
Twenty-eight consecutive patients with advanced PD underwent inpatient foslevodopa/foscarbidopa initiation between January 2025 and January 2026 at a quaternary academic medical center in Abu Dhabi, United Arab Emirates. Primary outcomes were Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, daily OFF/ON hours, and Hoehn and Yahr stage; secondary outcomes included Non-Motor Symptoms Scale (NMSS) total and domain scores and MDS-UPDRS Parts I and II. Motor assessments were conducted in the practically defined OFF state at baseline and in the ON state at follow-up on stable foslevodopa/foscarbidopa therapy. Safety was assessed by systematic recording of adverse events. Paired comparisons used Wilcoxon signed-rank tests.
RESULTS
Mean age was 61.3 ± 13.5 years; disease duration 10.1 ± 7.4 years; baseline levodopa equivalent daily dose 1018 ± 574 mg. MDS-UPDRS Part III improved from 50.7 ± 14.5 (OFF-state baseline) to 27.1 ± 13.6 (ON-state follow-up; change -23.6 ± 8.3, p < 0.0001), representing elimination of wearing-off disability. Daily OFF time fell from 2.8 ± 1.4 to 0.9 ± 0.6 h (-1.9 ± 1.4 h; p < 0.0001), and good ON time increased by 2.0 ± 1.3 h (p < 0.0001). Hoehn and Yahr stage improved from median 3 (interquartile range (IQR) 3-4) to 2 (IQR 2-3; p < 0.0001). Non-motor symptom burden decreased substantially: MDS-UPDRS Parts I and II fell by 22.7 ± 9.3 points (p = 0.001) and NMSS total score by 29.7 ± 18.7 points (~49% reduction; p = 0.0007). Infusion site reactions occurred in 22 patients (79%) but were generally manageable. Six patients (21%) discontinued therapy (median 4.8 months), primarily because of skin reactions or compliance difficulties.
CONCLUSION
Foslevodopa/foscarbidopa produced clinically meaningful improvements in motor fluctuations and non-motor symptom burden in this first Middle Eastern real-world cohort, supporting its role as an effective and feasible non-surgical device-aided therapy for advanced PD.
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Обработка статьи · этапы, ошибки и управление
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