Neuropsychiatric Adverse Events Associated With Foslevodopa/Foscarbidopa Continuous Subcutaneous Infusion in Clinical
David Campo-Caballero1,2,3,4, Jon Rodriguez-Antiguedad4,5,6,7, Arnau Puig-Davi4,5,6,7
1Department of Neurology, Movement Disorders Unit, Hospital Universitario Donostia, San Sebastián, Spain.
Foslevodopa/foscarbidopa continuous subcutaneous infusion (LDp/CDp CSI) can cause neuropsychiatric adverse events (AEs) in Parkinson's disease patients. Most AEs were mild-to-moderate and rarely led to treatment discontinuation.
Area of Science:
- Neurology
- Pharmacology
Background:
- Foslevodopa/foscarbidopa continuous subcutaneous infusion (LDp/CDp CSI) is effective for advanced Parkinson's disease (PD).
- Neuropsychiatric adverse events (AEs) have been reported with LDp/CDp CSI, with potential links to prior hallucinations or cognitive impairment.
Purpose of the Study:
- To determine the incidence and risk factors of neuropsychiatric AEs in a large, prospective, real-world cohort of PD patients treated with LDp/CDp CSI.
Main Methods:
- Analysis of data from the DATs-PD GETM Spanish Registry, an observational, prospective, multicenter, open-label study.
- Inclusion of 214 patients treated with LDp/CDp CSI, with assessment of baseline characteristics and follow-up for neuropsychiatric AEs.
Main Results:
- 19.2% of patients developed at least one neuropsychiatric AE during follow-up (median 163 days), mostly mild-to-moderate.
- Baseline impulse control disorders (ICDs) were associated with an increased risk of ICD-related AEs.
- No significant association was found between baseline cognitive impairment or psychotic features and the development of hallucinations/psychosis/confusion.
Conclusions:
- Neuropsychiatric AEs, primarily hallucinations/psychosis, occur in a relevant proportion of patients on LDp/CDp CSI but are generally mild and rarely lead to discontinuation.
- Baseline cognitive and psychotic features, apart from ICDs, did not increase the incidence of these AEs.
- LDp/CDp CSI can be used in appropriately selected patients with careful clinical monitoring.
Related Concept Videos
Drug Accumulation During Multiple Dosing: Intermittent IV Infusions
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Therapeutic Drug Monitoring: Affecting Factors
Chemotherapy-Induced Nausea and Vomiting: Dopamine Receptor Antagonists
Phenothiazines, such as prochlorperazine...
Bioavailability Study Design: Healthy Subjects Versus Patients
Clinical Trials: Overview

