Neuropsychiatric Adverse Events Associated With Foslevodopa/Foscarbidopa Continuous Subcutaneous Infusion in Clinical Practice: A Multicenter Study.
Neuropsychiatric Adverse Events Associated With Foslevodopa/Foscarbidopa Continuous Subcutaneous Infusion in Clinical Practice: A Multicenter Study.
Where did the research take place?
The study site has not been established. Author addresses may differ from where the research occurred.
ES · Author affiliation · country only
Department of Neurology, Movement Disorders Unit, Hospital Universitario Donostia, San Sebastián, Spain.Location evidence
Centro, ES · Author affiliation
Centro de Investigación Biomédica en Red-Enfermedades Neurodegenerativas (CIBERNED), Madrid, Spain.Location evidence
Madrid, ES · Author affiliation
Centro de Investigación Biomédica en Red-Enfermedades Neurodegenerativas (CIBERNED), Madrid, Spain.Location evidence
Barcelona, ES · Author affiliation
Medicine Department, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.Location evidence
Toledo, ES · Author affiliation
Unidad Trastornos del Movimiento, Complejo Hospitalario Universitario de Toledo, Toledo, Spain.Location evidence
Sant Joan Despí, ES · Author affiliation
Consorci Sanitari Integral, Hospital Moisés Broggi, Sant Joan Despí, Spain.Location evidence
Móstoles, ES · Author affiliation
Hospital Universitario de Móstoles, Madrid, Spain.Location evidence
Pontevedra, ES · Author affiliation
Complejo Hospitalario Universitario de Pontevedra (CHOP), Pontevedra, Spain.Location evidence
Palma, ES · Author affiliation
Hospital Universitario Son Espases, Palma de Mallorca, Spain.Location evidence
Oviedo, ES · Author affiliation
Hospital Universitario Central de Asturias (HUCA), Oviedo, Spain.Location evidence
Majadahonda, ES · Author affiliation
Unidad Trastornos del Movimiento, Servicio de Neurología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain.Location evidence
Sevilla, ES · Author affiliation
Unidad de Trastornos del Movimiento, Servicio de Neurología y Neurofisiología Clínica, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Sevilla, Spain.Location evidence
Universidad, ES · Author affiliation
Unidad de Trastornos del Movimiento, Servicio de Neurología y Neurofisiología Clínica, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Sevilla, Spain.Location evidence
Granada, ES · Author affiliation
Hospital Universitario Virgen de Las Nieves, Granada, Spain.Location evidence
Alicante, ES · Author affiliation
Hospital General Universitario Dr Balmis, Alicante, Spain.Location evidence
Elche, ES · Author affiliation
Hospital General Universitario de Elche, Alicante, Spain.Location evidence
A Coruña, ES · Author affiliation
CHUAC, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.Location evidence
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Original abstract
BACKGROUND: Foslevodopa/foscarbidopa continuous subcutaneous infusion (LDp/CDp CSI) has emerged as an effective and well-tolerated therapy for reducing OFF and increasing non-troublesome ON in advanced Parkinson's disease (PD). Neuropsychiatric adverse events (AEs) have been reported in both clinical trials and real-world studies, with some real-world cohorts suggesting higher rates among patients with prior hallucinations or cognitive impairment. The present study aimed to determine the incidence and risk factors of neuropsychiatric AEs in a large prospective real-world cohort. METHODS: We analyzed data from the DATs-PD GETM Spanish Registry, an observational, prospective, multicenter, open-label study. RESULTS: 214 patients treated with LDp/CDp CSI were included. Median age was 69 years, and median disease duration was 12 years. At baseline, 35% had cognitive impairment, 25.7% hallucinations/psychosis, and 26.2% impulse control disorders (ICDs). During follow-up after initiation (median 163 days), 19.2% developed at least one neuropsychiatric AE, mostly mild-moderate, and only 2.3% required device removal. Most events occurred more than 1 month after treatment initiation. In adjusted Cox, none of the evaluated variables were associated with the development of hallucinations/psychosis/confusion. The presence of ICD at baseline was associated with an increased risk of ICD-related AEs. CONCLUSION: Neuropsychiatric AEs, mainly hallucinations/psychosis, occurred in a clinically relevant proportion of patients treated with LDp/CDp CSI. However, they were generally mild-to-moderate and rarely led to treatment discontinuation. Except for ICD, baseline cognitive and psychotic features were not associated with higher incidence. These findings support its use in appropriately selected patients while highlighting the importance of individualized careful clinical monitoring.