title: The management and outcomes of fingolimod first dose cardiac monitoring in UK patients with relapsing-remitting multiple sclerosis.
abstract: BACKGROUND
  Patients initiated on Gilenya (fingolimod) require cardiovascular monitoring for 6h after the first dose. Novartis has engaged an independent provider (Regent's Park Heart Clinics [RPHC]) to provide a first dose observation (FDO) service to UK neurologists.
  
  
  OBJECTIVE
  To describe routinely-documented clinical observations (heart rate [HR], blood pressure [BP], cardiac rhythm [CR]) and outcomes from the RPHC fingolimod FDO service.
  
  
  METHODS
  Pseudonymised data (clinical observations pre-dose and for 6h after the first dose and any requirement for extended monitoring) were collected retrospectively from RPHC records for the first 850 RPHC FDO episodes (undertaken Jul-2012 to Jan-2015). All episodes involved patients with relapsing-remitting MS who were initiated on fingolimod in routine National Health Service (NHS) clinical practice.
  
  
  RESULTS
  In 78% of FDO episodes the patient was female. Mean age at date of episode was 40.1 years. Mean HR was 72.7 bpm (beats per minute) pre-dose, 64.3 bpm at 5h (the lowest recorded HR) and 66.1 bpm at 6h post-dose. New-onset heart block was observed in 2% of episodes (1.5% first-degree; 0.5% second-degree). The patient was discharged at 6 hours post-dose in 97% of episodes and required extended monitoring in 3%. In 5 episodes overnight monitoring was required. There were no episodes in which the patient required pharmacological intervention or temporary cardiac pacing.
  
  
  CONCLUSIONS
  In this real-world UK population fingolimod initiation was predominantly uneventful; clinical observations were similar to previous clinical trials.
authors: Novartis Pharmaceuticals, Frimley Business Park, Frimley, Camberley, United Kingdom. Electronic address: joedatt@doctors.org.uk.
authors: Joe
authors: J
authors: Datt
authors: pH Associates Ltd, Derwent House, Dedmere Road, Marlow, United Kingdom. Electronic address: laurabaldock@phassociates.com.
authors: Laura
authors: L
authors: Baldock
authors: Novartis Pharmaceuticals, Frimley Business Park, Frimley, Camberley, United Kingdom. Electronic address: emily.pull@novartis.com.
authors: Emily
authors: E
authors: Pull
authors: Regent's Park Heart Clinics (RPHC), 52 Brook Street, Mayfair, London, United Kingdom. Electronic address: bryn.webber@regentsparkhealthcare.com.
authors: Bryn
authors: B
authors: Webber
mesh_terms: D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000139:chemically induced / Q000175:diagnosis* / Q000517:prevention & control*; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000009:adverse effects*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D008297:Male; D008991:Monitoring, Physiologic; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride
keywords: First-dose monitoring; Gilenya (fingolimod); Multiple sclerosis; Observational research; Retrospective chart review; UK