title: Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial.
abstract: 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.
  
  
  BACKGROUND
  EudraCT 2011-000770-60.
authors.forename: Alice
authors.initials: A
authors.lastname: Laroni
authors.forename: Davide
authors.initials: D
authors.lastname: Brogi
authors.forename: Vincenzo Brescia
authors.initials: VB
authors.lastname: Morra
authors.forename: Leonello
authors.initials: L
authors.lastname: Guidi
authors.forename: Carlo
authors.initials: C
authors.lastname: Pozzilli
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.forename: Alessandra
authors.initials: A
authors.lastname: Lugaresi
authors.forename: Renato
authors.initials: R
authors.lastname: Turrini
authors.forename: Debora
authors.initials: D
authors.lastname: Raimondi
authors.forename: Antonio
authors.initials: A
authors.lastname: Uccelli
authors.affiliation: Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Largo Daneo 3, 16132 Genoa, Italy. glmancardi@neurologia.unige.it.
authors.forename: Giovanni Luigi
authors.initials: GL
authors.lastname: Mancardi
mesh_terms: D000293:Adolescent; D000328:Adult; D054537:Atrioventricular Block / Q000139:chemically induced / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D000068876:Fingolimod Hydrochloride; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D011409:Propylene Glycols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D013110:Sphingosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D011409:Propylene Glycols; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine