Ako, Alona (2026) Safety and Tolerability of Continuous Subcutaneous Foslevodopa Infusion in Advanced Parkinson’s Disease: A Retrospective Cohort Study Insights from Real-World Clinical Practice. thesis, Medicine.
Full text available on request.Abstract
Background: Continuous subcutaneous infusion of foslevodopa/foscarbidopa (LDp/CDp) has emerged as a non-surgical novel treatment option for Parkinson’s disease (PD). Independent real-world data on its safety and tolerability remain limited. Objective: To evaluate the safety, tolerability, discontinuation rate, and predictors of discontinuation of subcutaneous LDp/CDp in routine clinical practice. Methods: This multicenter observational retrospective cohort study included 109 patients with advanced PD treated with continuous subcutaneous LDp/CDp between February 2024 and December 2025 at two Dutch Parkinson care centers: Punt voor Parkinson Twente and Groningen. Adverse events (AEs), serious adverse events (SAEs), treatment discontinuation, and motor outcomes were analyzed. Kaplan -Meier analysis and Cox regression were used to assess time to discontinuation and associated predictors. Results: In our study group (median exposure: 248 days), six patients (5.5%) experienced treatment-related SAEs. Treatment was discontinued in 28.4% of patients, mainly due to skin�related adverse events. The Kaplan- Meier estimated treatment continuation rate at 12 months was 65%. The median time to discontinuation was not reached. In our cohort, 97% of patients reported at least one AE, most commonly infusion site reactions. The majority was mild to moderate. Longer disease duration, younger age at therapy initiation, and absence of prior advanced therapy were associated with higher discontinuation risk. In an analysis of patients with available data on motor symptom control (n = 16), the majority showed improvement in symptoms. Conclusion: In routine clinical practice, continuous subcutaneous foslevodopa infusion is generally safe. Serious adverse events were infrequent, however approximately one-third of patients discontinued treatment, most commonly due to skin reactions (15.6%). Optimized management of infusion site reactions is essential to improve long-term treatment adherence. Keywords: Parkinson’s disease, subcutaneous levodopa infusion, foslevodopa/foscarbidopa, safety and tolerability, adverse events, treatment discontinuation, survival analysis, observational study, retrospective study
| Item Type: | Thesis (UNSPECIFIED) |
|---|---|
| Supervisor name: | Dorresteijn, : Dr. L.D.A. |
| Faculty: | Medical Sciences |
| Date Deposited: | 14 Oct 2026 12:24 |
| Last Modified: | 14 Oct 2026 12:24 |
| URI: | https://umcg.studenttheses.ub.rug.nl/id/eprint/3964 |
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