Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population
This study looked at the short-term safety and tolerability of
fingolimod in patients with RRMS (2,282 (94.4%) completed the study).
Patients with pre-existing cardiac conditions or baseline cardiac
findings (PCCs) as well as those on beta-blockers (BBs) and/or calcium
channel blockers (CCBs) were included.
Using an ECG, heart rate and cardiac conduction was monitored for a
minimum of 6 hours after the first dose. They found that the initiation
of fingolimod was associated with a transient mostly asymptomatic
reduction in heart rate. Bradycardia was seen in 0.6% of patients and it
occurred more frequently in those on BBs or CCBs. Most of the events
were asymptomatic and recovered without pharmacological intervention.
The incidence of Mobitz type I second-degree AV block and 2:1 AV block
was higher in patients with PCCs (4.1% & 2%) compared to those
without any PCCs (0.9% & 0.3%) at 6 hours post dose. At the pre-dose
screening, patients with PCCs had the same incidence of Mobitz type I
second-degree AVB at 4.1%, with a slightly higher incidence of 2:1 AV
block at 0.7% that 6 hours post dose.
These results are similar to previous controlled studies, even after including patients with PCCs.
: Gold R, Comi G
: J Neurol. 2013 Nov 13. [Epub ahead of print]
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