title: Fingolimod effects on left ventricular function in multiple sclerosis.
abstract: BACKGROUND
  Cardiovascular side effects such as bradycardia and atrioventricular block were observed during the early clinical trials of fingolimod in multiple sclerosis, and one cardiovascular- linked death has been reported in the post-marketing period.
  
  
  OBJECTIVE
  To investigate the medium-term effects of fingolimod on heart function in order to obtain further insights into its cardiac safety profile.
  
  
  METHODS
  The study involved 53 patients starting treatment with fingolimod 0.5 mg daily and 25 patients treated with natalizumab 300 mg monthly. Cardiac function was assessed by means of echocardiography at baseline (T0), and after one (T1), six (T6), and (in the case of the fingolimod group) 12 months (T12).
  
  
  RESULTS
  Mean left ventricular ejection fraction significantly decreased and end-systolic volume increased from T0 to T1 (p=0.005) and T6 (p=0.0001) in the fingolimod but not the natalizumab group, although a slight increase was observed at T12. A similar decrease in ejection fraction was also observed after six months in nine patients switched from natalizumab to fingolimod.
  
  
  CONCLUSIONS
  Fingolimod significantly reduces left ventricular systolic function in MS patients. This effect has no clinical consequences in subjects without previous cardiac disorders, but suggests that more caution is required in patients with current or previous heart failure.
authors.affiliation: Cardiology Rehabilitation Department, Santa Maria Nascente Institute IRCCS, Don Carlo Gnocchi Foundation, Italy vracca@dongnocchi.it.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Racca
authors.affiliation: Technology Centre, Santa Maria Nascente Institute IRCCS, Don Carlo Gnocchi Foundation, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Di Rienzo
authors.affiliation: Multiple Sclerosis Centre, Santa Maria Nascente Institute IRCCS, Don Carlo Gnocchi Foundation, Italy.
authors.forename: Rosella
authors.initials: R
authors.lastname: Cavarretta
authors.affiliation: Cardiology Rehabilitation Department, Santa Maria Nascente Institute IRCCS, Don Carlo Gnocchi Foundation, Italy.
authors.forename: Anastasia
authors.initials: A
authors.lastname: Toccafondi
authors.affiliation: Technology Centre, Santa Maria Nascente Institute IRCCS, Don Carlo Gnocchi Foundation, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Vaini
authors.affiliation: Cardiology Rehabilitation Department, Santa Maria Nascente Institute IRCCS, Don Carlo Gnocchi Foundation, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Ferratini
authors.affiliation: Multiple Sclerosis Centre, Santa Maria Nascente Institute IRCCS, Don Carlo Gnocchi Foundation, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Rovaris
mesh_terms: D000328:Adult; D016022:Case-Control Studies; D004452:Echocardiography; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000627:therapeutic use*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D000069442:Natalizumab / Q000627:therapeutic use; D011446:Prospective Studies; D013318:Stroke Volume; D013599:Systole; D016277:Ventricular Function, Left / Q000187:drug effects* / Q000502:physiology
chemical_list: D007155:Immunologic Factors; D007166:Immunosuppressive Agents; D000069442:Natalizumab; D000068876:Fingolimod Hydrochloride
keywords: Fingolimod; cardiotoxicity; drug safety; drug side effects; left ventricular systolic function; multiple sclerosis; ventricular ejection fraction