Background: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disabilityprogression. 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 withRRMS without alternative therapeutic options.Methods: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hoursand 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) followingfingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-andsecond-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricularpremature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoringwas required in 34 patients.Conclusions: These results, in a population who better resembled real-world clinical practice in terms of concomitantdiseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration offingolimod is generally safe and well tolerated.
|Numero di pagine||10|
|Stato di pubblicazione||Published - 2014|