title: A Swiss real world best practice experience in three different clinical settings of the 6 hour fingolimod first dose observation procedure.
abstract: BACKGROUND
  The Swiss label of oral fingolimod (0.5 mg once daily) requires a 6-hour first dose observation (FDO) including an ECG prior to and 6 hours after the first intake but in comparison to other countries such as Austria, Australia and Canada there are no restrictions regarding the clinical settings of the FDO procedure in Switzerland. We present here our real-world experience of the 6 hour FDO procedure in three different clinical settings, following fingolimod treatment initiation. This is the first report on the FDO of fingolimod in these real-world clinical settings in Swiss patients with multiple sclerosis (MS).
  
  
  METHODS
  This was a retrospective, multi-clinic, observational study of 136 patients with relapsing-remitting multiple sclerosis. Summary statistics have been used to present the data.
  
  
  RESULTS
  Only two patients (<1.5% [2/136]) experienced symptoms after the first dose of fingolimod. Atrioventricular conduction abnormalities were reported in 3% (4/136) of patients, which resolved spontaneously within 24 hours of treatment initiation. During the average 6.8 months follow-up, 96% (131/136) of the patients remained on therapy
  
  
  CONCLUSIONS
  These findings support the safety and feasibility of FDO and tolerability of fingolimod in real-world clinical settings.
authors.affiliation: Cantonal Hospital Aarau, Aarau, Switzerland. Simon.Ramseier@ksa.ch.
authors.forename: Simon P
authors.initials: SP
authors.lastname: Ramseier
authors.affiliation: Clinique de Carouge SA, Carouge, Switzerland. serge.roth@latour.ch.
authors.forename: Serge
authors.initials: S
authors.lastname: Roth
authors.affiliation: Neurocentre Bellevue, Theaterstrasse 8, Zurich, CH-8001, Switzerland. mc@neurozentrumbellevue.ch.
authors.forename: Adam
authors.initials: A
authors.lastname: Czaplinski
mesh_terms: D004562:Electrocardiography / Q000706:statistics & numerical data*; D000068876:Fingolimod Hydrochloride / Q000009:adverse effects*; D019983:Guideline Adherence / Q000706:statistics & numerical data; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D013557:Switzerland
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride