Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

Giuseppe Salemi, Giovanni L. Mancardi, Alice Laroni, Luciano Deotto, Appendino, Davide Brogi, Bonaventura Ardito, Cavallo, Rosati, Lenzi, Bosco, Batocchi, Cottone, Benedetti, Bergamaschi, Luca Massacesi, Dotta, Renato Turrini, Mario Guidotti, Tinebra AstiIudice, Debora Raimondi, Vecchio, Centonze, Danni, Gallo, Patrizia Sola, Francia, Scarpini, Schoenhuber, Sinisi, Bellantonio, Maria Buccafusca, Bortolon, Malentacchi, Alessandra Protti, Serrati, Daniele Spitaleri, Avolio, Provera, Lus, Leonardo Sinisi, Ulivelli, Francesca De Robertis, Tezzon, Cavalla, Vincenzo B. Morra, Lorenzo Lorusso, Maimone, Zimatore, Florio, Giometto, Schoenhuber, Coniglio, Patrizia Perrone, Galgani, Salemi, Totaro, Antonio Uccelli, Fabio Bandini, Millefiorini, Alessandra Lugaresi, Sarchielli, Trojano, Leonello Guidi, Ghezzi, Rovaris, Gianfranco Costantino, Carlo Pozzilli, Melato, Di Battista, Tola, Montanari, Luigi M.E. Grimaldi, Patti, Mantegazza, Giuliani, Giulio Rosati, Aldo Quattrone, Gioacchino Tedeschi, Maria Pia Amato, Giancarlo Comi, Filippi, Cargnelutti, Francesco Saccà, Rasi

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Abstract

Background: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disabilityprogression. First dose administration of fingolimod is associated with a transient, dose-dependent decrease in heart rate(HR) in the 6 hours after drug intake.The aim of the study is to to assess safety and tolerability of the first dose of fingolimod in a cohort of Italian patients withRRMS without alternative therapeutic options.Methods: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hoursand had their vital signs monitored hourly. Extended on-site monitoring was provided when required.Results: Of the 906 patients enrolled in the study, most (95.2%) did not experience any adverse event (AE) followingfingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-andsecond-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricularpremature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoringwas required in 34 patients.Conclusions: These results, in a population who better resembled real-world clinical practice in terms of concomitantdiseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration offingolimod is generally safe and well tolerated.
Lingua originaleEnglish
pagine (da-a)65-74
Numero di pagine10
RivistaBMC Neurology
Volume14
Stato di pubblicazionePublished - 2014

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All Science Journal Classification (ASJC) codes

  • Clinical Neurology

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Salemi, G., Mancardi, G. L., Laroni, A., Deotto, L., Appendino, Brogi, D., Ardito, B., Cavallo, Rosati, Lenzi, Bosco, Batocchi, Cottone, Benedetti, Bergamaschi, Massacesi, L., Dotta, Turrini, R., Guidotti, M., ... Rasi (2014). Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial. BMC Neurology, 14, 65-74.