Abstract Details

Title Cardiac Effects of Fingolimod after First Dose Administration and Therapy Change in Patients with Multiple Sclerosis

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 170

Objective

Background BACKGROUND: Treatment initiation with fingolimod can induce a transient, generally asymptomatic reduction in heart rate that is maximal by 4 to 6 hours after the first dose and attenuates over the following weeks with continued dosing.

Design/Methods DESIGN/METHODS: Eligible patients for the 6-month, multicenter, phase 4 study to Evaluate Patient OutComes (EPOC; NCT01216072) had relapsing MS, were fingolimod naive, and had received ?6 months' continuous treatment with a standard DMT (interferon ? or glatiramer acetate) before study initiation. Patients with significant cardiac history or poorly controlled hypertension were excluded. Patients were assigned 3:1 to open-label fingolimod 0.5 mg or standard DMT with no washout of prior DMT. First dose observation assessments included a predose electrocardiogram (ECG) and predose (plus hourly postdose) measurements of sitting HR and blood pressure (BP) and a subgroup of patients had a 6 hour post dose ECG.

Results RESULTS: Patients receiving fingolimod (n=783) were mostly women (75.9%) mean age of 46.0 years. Mean predose HR was 74.1 bpm. Nadir heart rate was reached by 5 h postdose (mean change from baseline, -8.3 bpm) and began to recover by 6 h. Eight patients (1%) had symptomatic bradycardia, most frequently dizziness, all spontaneously recovered with no treatment. 139 patients had a post dose ECG with no second degree AV block observed.

Conclusions CONCLUSIONS: Consistent with previous studies, treatment initiation effects were transient and benign in nature.

Authors/Disclosures
Bruce L. Hughes, MD, FAAN (MercyOne) PRESENTER	No disclosure on file
Mark C. Cascione, MD (Tampa Neurology Associates)	No disclosure on file
	No disclosure on file
	No disclosure on file
Lesley Schofield	No disclosure on file
Edward Kim (Novartis Pharmaceuticals Corporation)	No disclosure on file
Luigi M. Barbato, MD (Jazz Pharmaceuticals)	Dr. Barbato has nothing to disclose.
William M. Carroll, MD, MBBS, FRACP, FAAN (SJOG Neurology)	Dr. Carroll has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Carroll has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck.

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