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

Alice Laroni, Davide Brogi, Vincenzo B. Morra, Leonello Guidi, Carlo Pozzilli, Giancarlo Comi, Alessandra Lugaresi, Renato Turrini, Debora Raimondi, Antonio Uccelli, Giovanni L. Mancardi, M. P. Amato, L. Appendino, B. Ardito, C. Avolio, F. Bandini, A. P. Batocchi, P. Bellantonio, M. D. Benedetti, R. BergamaschiF. Bortolon, A. Bosco, M. Buccafusca, D. Cargnelutti, P. Cavalla, R. Cavallo, D. Centonze, M. G. Coniglio, G. Costantino, S. Cottone, M. C. Danni, F. De Robertis, L. Deotto, M. Dotta, G. Di Battista, M. M. Filippi, C. Florio, A. Francia, S. Galgani, P. Gallo, A. Ghezzi, B. Giometto, G. Giuliani, L. M E Grimaldi, M. Guidotti, A. Iudice, G. L. Lenzi, L. Lorusso, G. Lus, D. Maimone, G. M. Malentacchi, R. E. Mantegazza, L. Massacesi, M. Melato, E. Millefiorini, E. Montanari, F. Patti, P. S M Perrone, A. Protti, P. Provera, A. Quattrone, F. Rasi, G. Rosati, M. Rovaris, F. Saccà, G. Salemi, P. Sarchielli, E. A. Scarpini, R. Schoenhuber, C. Serrati, L. Sinisi, P. Sola, D. L A Spitaleri, G. Tedeschi, F. Tezzon, M. C. Tinebra Asti, M. R. Tola, R. Totaro, M. Trojano, M. Ulivelli, M. M. Vecchio, G. B. Zimatore

Research output: Contribution to journalArticlepeer-review


Background: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. 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 with RRMS without alternative therapeutic options. Methods: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and 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) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. Conclusions: These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated.

Original languageEnglish
Article number65
JournalBMC Neurology
Issue number1
Publication statusPublished - Apr 1 2014


  • Atrioventricular block
  • Bradycardia
  • Fingolimod
  • Multiple sclerosis
  • Safety
  • Tolerability

ASJC Scopus subject areas

  • Clinical Neurology
  • Medicine(all)


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