Τίτλος:
A Prospective, Observational, Cohort Study to Assess the Efficacy and Safety of Prolonged-Release Fampridine in Cognition, Fatigue, Depression, and Quality of Life in Multiple Sclerosis Patients: The FAMILY Study
Περίληψη:
Introduction: The efficacy of prolonged-release fampridine (PR-FAM) may extend in multiple sclerosis (MS) beyond walking ability. The objective of this study was to evaluate the effect of PR-FAM treatment on cognition, fatigue, depression, and quality of life (QoL) in adult patients with MS in a real-world setting. Methods: FAMILY was a multi-center, prospective, observational, real-world cohort study of MS patients receiving PR-FAM in the outpatient setting. Patients were treated as per PR-FAM’s local prescribing information for 6 months. Standardized protocols and questionnaires were used to evaluate changes in cognition (PASAT; Paced Auditory Serial Addition Test), fatigue (MFIS; Modified Fatigue Impact Scale), depression (BDI-II; Beck Depression Inventory-II) and QoL (MusiQoL; MS International Quality-of-Life questionnaire, MSIS-29; Multiple Sclerosis Impact Scale: PHYS and PSYCH subscales) at 3 and 6 months compared to baseline. Results: In total, 102 eligible patients from 8 sites in Greece were analysed, of whom 92 completed the study and 10 discontinued. At 6 months, PR-FAM treatment resulted in improvements from baseline in PASAT-3′′ (p = 0.044), MFIS (p < 0.001), BDI-II (p < 0.001), MusiQoL (p < 0.001) and MSIS-29-PHYS (p = 0.012) and MSIS-PSYCH (p < 0.001). A positive effect was evident already at 3 months in PASAT-3′′ (ns), MFIS (p = 0.020), BDI-II (p = 0.034), MusiQoL (p = 0.001), MSIS-29-PHYS (ns) and MSIS-29-PSYCH (p < 0.001). Conclusions: This observational study provides new data to the current literature in support of PR-FAM’s positive effects in cognition, fatigue, depression, and QoL in a large, heterogeneous group of Greek MS patients in the real-world setting. Trial Registration: ClinicalTrials.gov identifier, NCT03164018. © 2021, The Author(s).
Συγγραφείς:
Mitsikostas, D.D.
Doskas, T.
Gkatzonis, S.
Fakas, N.
Maltezou, M.
Papadopoulos, D.
Gourgioti, R.
Mitsias, P.
Λέξεις-κλειδιά:
alemtuzumab; antidepressant agent; anxiolytic agent; azathioprine; beta1a interferon; beta1b interferon; cyclophosphamide; dimethyl fumarate; fampridine; fingolimod; glatiramer; mitoxantrone; natalizumab; teriflunomide, adult; agitation; Article; asthma; atrial fibrillation; backache; Beck Depression Inventory; clinical assessment; clinical evaluation; clinical practice; cluster headache; cognition; cohort analysis; comparative effectiveness; constipation; controlled study; depression; dizziness; drug effect; drug efficacy; drug safety; dyspnea; fatigue; Fatigue Impact Scale; female; functional status assessment; Greece; headache; human; hyperhidrosis; hypertension; hypesthesia; insomnia; major clinical study; male; middle aged; migraine; Modified Fatigue Impact Scale; multicenter study; multiple sclerosis; Multiple Sclerosis Impact Scale; Multiple Sclerosis International Quality of Life Questionnaire; Multiple Sclerosis Walking Scale; nausea; observational study; outpatient care; paced auditory serial addition test; positional vertigo; prescription; presyncope; prospective study; quality of life; quality of life assessment; questionnaire; respiratory tract infection; restlessness; sleep disorder; social psychology; somnolence; tachycardia; upper abdominal pain; upper respiratory tract infection; urinary tract infection; walking speed; cognition; depression; fatigue, Adult; Cognition; Cohort Studies; Depression; Fatigue; Greece; Humans; Multiple Sclerosis; Prospective Studies; Quality of Life
