Effect of fingolimod on cardiac autonomic regulation in patients with multiple sclerosis

Mult Scler. 2016 Jul;22(8):1080-5. doi: 10.1177/1352458515604384. Epub 2015 Sep 11.

Abstract

Background: Fingolimod modulates sphingosine-1-phosphate receptors that are also found in cardiovascular tissue.

Objective: To investigate the effects of fingolimod on cardiac autonomic regulation prospectively.

Methods: Twenty-seven relapsing-remitting multiple sclerosis patients underwent 24-hour electrocardiogram recording before, at the first day of fingolimod treatment (1d) and after three months of continuous dosing (3mo). The time interval between two consecutive R-peaks (RR-interval) was measured. Cardiac autonomic regulation was assessed by the various parameters of heart rate variability. Parasympathetic stimulation prolongs the RR-interval and increases heart rate variability while the effects of sympathetic stimulation are mainly the opposite. The low frequency/high frequency ratio reflects sympathovagal balance.

Results: From baseline to 1d, a prolongation of the RR-interval (P<0.001), an increase in the values of various heart rate variability parameters (P<0.05 to P<0.001) and a decrease in the low frequency/high frequency ratio (P<0.05) were demonstrated. At 3mo, although the RR-interval remained longer (P<0.01), the values of various heart rate variability parameters were lower (P<0.01 to P<0.001) as compared to baseline. At 3mo, the low frequency/high frequency ratio (P<0.05) was higher in men than in women although no such difference was found at baseline or at 1d.

Conclusions: After an initial increase in parasympathetic regulation, continuous fingolimod dosing shifts cardiac autonomic regulation towards sympathetic predominance, especially in men. Careful follow-up of fingolimod-treated relapsing-remitting multiple sclerosis patients is warranted as sympathetic predominance associates generally with impaired outcome.ClinicalTrials.cov: NCT01704183.

Keywords: Cardiac autonomic regulation; fingolimod; heart rate variability; multiple sclerosis.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Electrocardiography, Ambulatory
  • Female
  • Fingolimod Hydrochloride / therapeutic use*
  • Heart / innervation*
  • Heart Rate / drug effects*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / diagnosis
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Multiple Sclerosis, Relapsing-Remitting / physiopathology
  • Parasympathetic Nervous System / drug effects*
  • Parasympathetic Nervous System / physiopathology
  • Prospective Studies
  • Sex Factors
  • Sympathetic Nervous System / drug effects*
  • Sympathetic Nervous System / physiopathology
  • Time Factors
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Fingolimod Hydrochloride

Associated data

  • ClinicalTrials.gov/NCT01704183