Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson's disease

Francesc Valldeoriola; María José Catalán; Francisco Escamilla-Sevilla; Eric Freire; Jesús Olivares; Esther Cubo; Diego Santos García; Matilde Calopa; Pablo Martínez-Martín; Juan Carlos Parra; Gloria Arroyo; José Matías Arbelo

doi:10.1038/s41531-021-00246-y

Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson's disease

NPJ Parkinsons Dis. 2021 Nov 30;7(1):108. doi: 10.1038/s41531-021-00246-y.

Affiliations

¹ Movement Disorders Unit, Neurology Service, Clínic Hospital, 170, Villarroel St., 08036, Barcelona, Spain. fvallde@clinic.cat.
² Neurology Service, Clínico San Carlos Hospital, Profesor Martín Lagos St., 28040, Madrid, Spain.
³ Movement Disorders Unit. Neurology Service, Virgen de las Nieves University Hospital, "Biohealth Investigation Institute. Ibs, Granada, Spain.
⁴ Neurology Service, Elche University General Hospital, 11, Camino Almazara St., 03203, Elche, Alicante, Spain.
⁵ Neurology Service, Torrecárdenas Hospital Center, Hermandad de Donantes de Sangre St., 04009, Almería, Spain.
⁶ Neurology Service, Burgos University Hospital, 3, Islas Baleares Av., 09006, Burgos, Spain.
⁷ Department of Neurology, A Coruña University Hospital Center (CHUAC), A Coruña, Spain.
⁸ Neurology Service, Bellvitge University Hospital, Feixa Llarga St., 08907L'Hospitalet de Llobregat, Barcelona, Spain.
⁹ National Center of Epidemiology and Center for Networked Biomedical Research in Neurodegenerative Diseases (CIBERNED), Carlos III Institute of Health, 5, Monforte de Lemos Av., 28029, Madrid, Spain.
¹⁰ AbbVie Spain, S.L.U., 91, De Burgos Av., 28050, Madrid, Spain.
¹¹ Neurology Service, Insular of Gran Canaria University Hospital, Marítima del Sur Av., 35016, Las Palmas, de Gran Canaria, Spain.

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 < 0.0001), motor symptoms (UPDRS-III in "On," -6.5 ± 11.8; P = 0.0002), NMS (NMSS, -35.7 ± 31.1; P < 0.0001), mood (Norris/Bond-Lader VAS, -6.6 ± 21.1; 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 < 0.0001), and patient treatment satisfaction (SATMED-Q, 16.1 ± 16.8; P < 0.0001). There were significant correlations between the change from baseline to 6 months between PDQ-39 and UPDRS-IV, NMSS, BAI, BDI-II, AS, and PFS-16 scores, and Norris/Bond-Lader alertness/sedation factor. Caregiver anxiety also improved (Goldberg anxiety scale, -1.1 ± 1.0; 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.