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.

Authors: Gold R, Comi G
Source: J Neurol. 2013 Nov 13. [Epub ahead of print]
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