Multiple Sclerosis Clinical Trial
Official title:
FINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis
The current study sought to prolong the observational interval after initiating medication with fingolimod and to measure the long-term effects of fingolimod on HR and HRV as an indicator of autonomic nervous system function in patients with RR-MS.
Fingolimod (Gilenya®; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA) is a novel
oral disease-modifying therapy that acts as a sphingosine-1-phosphate (S1P) receptor agonist
and reduces the recirculation of lymphocytes to blood and peripheral tissues, including
inflammatory lesions.
A critical part of fingolimod therapy still remains in the screening and initiation phases
because of the risk of cardiac events. It is well known that the first dose of fingolimod is
associated with a decrease in heart rate (HR) and slowing of atrioventricular (AV)
conduction. Patients were continuously observed for a minimum of 6 hours after taking
fingolimod. Because resurgence of heart rate began at 6 hours, the actual recommendation for
observation is only 6 hours. Data about the effect of fingolimod after this time period is
lacking.
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