Abstract
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.
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Acknowledgments
This work was funded by the government as a non-commercial TEVO-funding (grant number 12178).
Conflict of Interest
SS has been the congress representative of Mikkeli Central Hospital and sponsored by industry (BiogenIdec, Boehringer Ingelheim, Genzyme, GlaxoSmithKline, Novartis, OrionPharma, Sanofi, TEVA) and speaker in symposiums sponsored by industry (BiogenIdec, Novartis, TEVA).
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TT: None
JH: None
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ClinicalTrials.gov: NCT01704183
Juha E. K. Hartikainen and Päivi Hartikainen contributed equally to this work.
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Simula, S., Laitinen, T., Laitinen, T.M. et al. Effects of Three Months Fingolimod Therapy on Heart Rate. J Neuroimmune Pharmacol 10, 651–654 (2015). https://doi.org/10.1007/s11481-015-9619-8
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DOI: https://doi.org/10.1007/s11481-015-9619-8