title: Early safety and efficacy of fingolimod treatment in Denmark.
abstract: BACKGROUND
  Initiation of fingolimod treatment is associated with a transient decrease of heart rate, and atrioventricular (AV) conduction block may occur.
  
  
  OBJECTIVE
  To evaluate the therapeutic effect and safety of fingolimod treatment in MS patients in Denmark with focus on cardiac and pulmonary side effects at treatment onset.
  
  
  METHODS
  We analysed data from the first 496 fingolimod-treated Danish patients, observed for at least 3 months. In a subset of 204 patients, we monitored cardiac and pulmonary adverse effects following treatment initiation.
  
  
  RESULTS
  The overall annualized relapse rate (ARR) was 0.37 (95% CI 0.31-0.44); 0.22 (95% CI 0.03-0.81) in de novo-treated patients, 0.29 (95% CI; 0.23-0.37) in patients switching from IFN-beta or GA and 0.46 (9 5% CI 0.34-0.60) after natalizumab. In the subset of 204 patients, 8 (3.9%) required prolonged cardiac monitoring due to bradycardia and/or second-degree AV block type I. All patients recovered spontaneously. Two patients discontinued fingolimod. Eleven (5.4%) patients reported respiratory complaints and two of these patients discontinued treatment.
  
  
  CONCLUSIONS
  Fingolimod appears to be safe and effective in MS patients in a clinical setting. Mild cardiac adverse effects occurred at a similar rate as in clinical trials.
authors.affiliation: Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: A
authors.initials: A
authors.lastname: Voldsgaard
authors.affiliation: Department of Clinical Epidemiology, University of Aarhus, Copenhagen, Denmark.|Danish Multiple Sclerosis Registry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: N
authors.initials: N
authors.lastname: Koch-Henriksen
authors.affiliation: Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.|Danish Multiple Sclerosis Registry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Magyari
authors.affiliation: Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.|University of Copenhagen, Copenhagen, Denmark.
authors.forename: F
authors.initials: F
authors.lastname: Sellebjerg
authors.affiliation: Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.|University of Copenhagen, Copenhagen, Denmark.
authors.forename: P S
authors.initials: PS
authors.lastname: Sørensen
authors.affiliation: Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.|University of Copenhagen, Copenhagen, Denmark.
authors.forename: A B
authors.initials: AB
authors.lastname: Oturai
mesh_terms: D000328:Adult; D000368:Aged; D066126:Cardiotoxicity / Q000209:etiology; D003718:Denmark; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000009:adverse effects* / Q000627:therapeutic use; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D012119:Respiration / Q000187:drug effects
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride
keywords: adverse effects; cardiac; fingolimod; first-dose monitoring; multiple sclerosis; respiratory; safety