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Riluzole use in presence of contraindications in adults affected by amyotrophic lateral sclerosis and its off-label use in other motor neuron diseases: Findings from an Italian multicentre study (the CAESAR project)

Affiliation
Department of Neurosciences, Psychology, Drug Research and Child Health ,Section of Pharmacology and Toxicology ,University of Florence ,Florence ,Italy
Crescioli, Giada;
Affiliation
Department of Epidemiology ,Latium Regional Health Service ,Rome ,Italy
Finocchietti, Marco;
Affiliation
Department of Epidemiology ,Latium Regional Health Service ,Rome ,Italy
Cascini, Silvia;
Affiliation
Regional Health Agency of Tuscany ,Pharmacoepidemiology Unit ,Florence ,Italy
Paoletti, Olga;
Affiliation
Health ICT Service ,Regional Health Authority of Umbria ,Perugia ,Italy
Franchini, David;
Affiliation
Department of Clinical and Experimental Medicine ,Unit of Pharmacology and Pharmacovigilance ,University of Pisa ,Pisa ,Italy
Cappello, Emiliano;
Affiliation
Department of Clinical and Experimental Medicine ,Unit of Pharmacology and Pharmacovigilance ,University of Pisa ,Pisa ,Italy
Valdiserra, Giulia;
Affiliation
National Center for Disease Prevention and Health Promotion ,Italian National Institute of Health ,Rome ,Italy
Sciancalepore, Francesco;
Affiliation
Neurophysiopathology Unit ,Perugia Hospital ,Perugia ,Italy
Celani, Maria Grazia;
Affiliation
Department of Clinical and Experimental Medicine ,Unit of Pharmacology and Pharmacovigilance ,University of Pisa ,Pisa ,Italy
Tuccori, Marco;
Affiliation
Department of Neurosciences, Psychology, Drug Research and Child Health ,Section of Pharmacology and Toxicology ,University of Florence ,Florence ,Italy
Vannacci, Alfredo;
Affiliation
Department of Neurosciences, Psychology, Drug Research and Child Health ,Section of Pharmacology and Toxicology ,University of Florence ,Florence ,Italy
Lombardi, Niccolò;
Affiliation
Department of Epidemiology ,Latium Regional Health Service ,Rome ,Italy
Kirchmayer, Ursula; Addis, Antonio; Ancidoni, Antonio; Bacigalupo, Ilaria; Bargagli, Anna Maria; Belleudi, Valeria; Bonaiuti, Roberto; Brunori, Paola; Bucaneve, Giampaolo; Cantisani, Teresa Anna; Cascini, Silvia; Celani, Maria Grazia; Convertino, Irma; Crescioli, Giada; Finocchietti, Marco; Gini, Rosa; Hyeraci, Giulia; Kirchmayer, Ursula; Lombardi, Niccolò; Paoletti, Olga; Rocchi, Rosalba Elisabetta; Rossi, Mariangela; Sciancalepore, Francesco; Tuccori, Marco; Vanacore, Nicola; Vannacci, Alfredo

Background: This analysis describes the use of riluzole in amyotrophic lateral sclerosis (ALS) individuals with contraindications and off-label use for subjects with other motor neuron diseases (o-MND) in the Italian regions of Latium, Tuscany and Umbria. Methods: A cohort of adults with ALS prescribed with riluzole during the years 2016–2019 was enrolled from administrative healthcare databases, excluding subjects with o-MND in the preceding 5 years. Being affected by ALS for more than 5 years, presence of tracheostomy, renal or hepatic failure were considered as contraindications to the use of riluzole. A cohort of adults with o-MND was enrolled in 2016–2019 for whom off-label use of riluzole was retrieved up to 4 years, analysing over the time differences related to sex. Results: Among 206 ALS individuals prescribed with riluzole in Latium, 336 in Tuscany and 60 in Umbria, less than 1% were diagnosed with ALS for more than 5 years. Less than 2% were tracheotomised or affected by hepatic failure. Renal failure was documented for 1.9%, 2.7%, and 5.0% of ALS individuals in Latium, Tuscany and Umbria. The o-MND cohort comprised 264 subjects in Latium, 222 in Tuscany, and 66 in Umbria. Non-negligible off-label riluzole use was observed: 8.5%, 33.0%, and 4.2% in females, and 19.9%, 26.5% and 2.4% in males in Latium, Tuscany and Umbria. Discussion: Riluzole use in ALS individuals in the presence of contraindications is rare, with slightly higher numbers in presence of renal failure. Off-label use in o-MND was found to be non-negligible, with variations between sexes.

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License Holder: Copyright © 2022 Crescioli, Finocchietti, Cascini, Paoletti, Franchini, Cappello, Valdiserra, Sciancalepore, Celani, Tuccori, Vannacci, Lombardi, Kirchmayer and the CAESAR Study Group.

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