Fingolimod is a novel disease-modifying drug for relapsing-remitting multiple sclerosis (RRMS). Fingolimod initiation associates with a decrease in heart rate (HR). However, the long-term effects of fingolimod on HR are not known. The aim of this study was prospectively investigate the effect of 3-month fingolimod therapy on HR. Twenty-seven RRMS patients underwent 24-h ambulatory electrocardiogram recording 20 ± 16 days before (baseline) and at the day of fingolimod initiation (1 day). Twenty-four patients completed 3 months follow-up (3 months). The average HR over 24-h and the average HR for daytime and nighttime were assessed at baseline, 1 day and 3 months. Fingolimod initiation resulted in slowing of HR from 82 ± 11 1/min at baseline to 63 ± 9.5 1/min at 5 h after the initiation of the therapy. The average HR during 24-h was lower at 1d (66 ± 7.8 1/min;p < 0.001) and also at 3 months (69 ± 8.3 1/min;p < 0.001) as compared to baseline (74 ± 10 1/min). The average daytime HR at 1 day (68 ± 8.4 1/min) was lower as compared to baseline (78 ± 11 1/min, p < 0.001), whereas no difference was found between the average daytime HR at baseline and at 3 months (79 ± 10 1/min). The average nighttime HR at 1 day (59 ± 8.8 1/min;p < 0.001) and at 3 months (60 ± 9.2 1/min;p < 0.05) both were lower than at baseline (64 ± 9.9 1/min). In conclusion, fingolimod resulted in HR decrease reaching the nadir at 5 h after the first dose. HR remained lower after 3 months fingolimod treatment as compared to baseline. Particularly, HR at daytime recovered whereas the nighttime HR showed not recovery as compared to the day of fingolimod initiation.
Trial registration: ClinicalTrials.gov NCT01704183.
Keywords: Disease modifying therapies; Fingolimod; Heart rate; Multiple sclerosis.