Fingolimod first-dose effects in patients with relapsing multiple sclerosis concomitantly receiving selective serotonin-reuptake inhibitors

Publication date: Available online 13 April 2015 Source:Multiple Sclerosis and Related Disorders Author(s): R. Bermel , R. Hashmonay , X. Meng , S. Randhawa , P. von Rosenstiel , N. Sfikas , D. Kantor Selective serotonin-reuptake inhibitors (SSRIs), commonly administered for depression and anxiety in patients with multiple sclerosis, are associated with QT interval prolongation. Fingolimod (FTY720; Gilenya®, Novartis Pharma AG) is a first-in-class sphingosine 1-phosphate receptor modulator approved for relapsing forms of multiple sclerosis. Fingolimod first-dose administration is associated with a transient, generally asymptomatic, slowing of heart rate, which may also prolong QT interval. This post hoc analysis compared cardiac outcomes in over 3300 patients with relapsing multiple sclerosis who were or were not receiving SSRIs during fingolimod treatment initiation, including a subset of patients receiving citalopram or escitalopram. Vital signs were recorded hourly for 6h, and electrocardiograms were obtained pre-dose and 6h post-dose. Changes in mean hourly heart rate from baseline (pre-dose) to 6h post-dose were similar among patients not receiving an SSRIs (fingolimod 0.5mg, –7.5bpm; placebo, 0.0bpm) and those receiving SSRIs (fingolimod 0.5mg, –6.6bpm; placebo, 0.3bpm). In patients treated with fingolimod 0.5mg, the mean change in corrected QT interval from baseline to 6h after treatment initiation was under 10ms, and few patients had absolute corrected...
Source: Multiple Sclerosis and Related Disorders - Category: Neurology Source Type: research