1. Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease
- Author
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Francesc Valldeoriola, Esther Cubo, E. Freire, Juan Carlos Parra, Diego Santos García, María José Catalán, Pablo Martinez-Martin, Matilde Calopa, Jesús Olivares, José Matías Arbelo, Gloria Arroyo, Francisco Escamilla-Sevilla, and AbbVie
- Subjects
medicine.medical_specialty ,Parkinson's disease ,Sedation ,Article ,Cellular and Molecular Neuroscience ,Clinical trials ,Quality of life ,Malaltia de Parkinson ,Internal medicine ,medicine ,Clinical endpoint ,Apathy ,Adverse effect ,RC346-429 ,business.industry ,Cuidadors ,Patient satisfaction ,medicine.disease ,Mood ,Caregivers ,Neurology ,Outcomes research ,Satisfacció dels pacients ,Anxiety ,Neurology (clinical) ,Neurology. Diseases of the nervous system ,medicine.symptom ,business ,Assaigs clínics - Abstract
Levodopa-carbidopa intestinal gel (LCIG) has shown to be efficacious in motor and non-motor symptoms (NMS). Nevertheless, studies with patient Quality of Life (QoL) as a primary endpoint are scarce. To assess the effect of LCIG on Advanced Parkinson’s Disease (APD) patients QoL. Secondarily, the impact on motor symptoms and NMS, emotional well-being, treatment satisfaction, and caregiver QoL, stress, disease burden, anxiety, depression, and work impairment were also investigated. In this prospective, 6-month multicenter postmarketing observational study, LCIG was administered to 59 patients with APD. Endpoints were assessed using validated scales and questionnaires. LCIG significantly improved patient QoL (PDQ-39 mean change ± standard deviation from baseline, −12.8 ± 14.6; P P = 0.0002), NMS (NMSS, −35.7 ± 31.1; P P = 0.0297), fatigue (PFS-16, −0.6 ± 1.0; P = 0.0003), depression (BDI-II, −5.1 ± 9.4; P = 0.0002), anxiety (BAI, −6.2 ± 9.6; P P P = 0.0234), but the clinical relevance of this finding is questionable. The serious adverse events reported were similar to those previously described for LCIG. In patients with APD, LCIG improves QoL, motor symptoms and NMS, emotional well-being, and satisfaction with the treatment. Improvement in patient QoL is associated with improvements in motor complications, NMS, anxiety, depression, apathy and fatigue. Improvements in patients’ QoL does not correspond with improvements in caregivers’ QoL or burden.
- Published
- 2021