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Abstract

Background:
Patients initiated on Gilenya (fingolimod) require cardiovascular monitoring for 6 h after the first dose. Novartis has engaged an independent provider (Regent's Park Heart Clinics [RPHC]) to provide a first dose observation (FDO) service to UK neurologists.

Objectives:
To describe routinely-documented clinical observations (heart rate [HR], blood pressure [BP], cardiac rhythm [CR]) and outcomes from the RPHC fingolimod FDO service.

Methods:
Pseudonymised data (clinical observations pre-dose and for 6 h after the first dose and any requirement for extended monitoring) were collected retrospectively from RPHC records for the first 850 RPHC FDO episodes (undertaken Jul-2012 to Jan-2015). All episodes involved patients with relapsing-remitting MS who were initiated on fingolimod in routine National Health Service (NHS) clinical practice.

Results:
In 78% of FDO episodes the patient was female. Mean age at date of episode was 40.1 years. Mean HR was 72.7 bpm (beats per minute) pre-dose, 64.3 bpm at 5 h (the lowest recorded HR) and 66.1 bpm at 6 h post-dose. New-onset heart block was observed in 2% of episodes (1.5% first-degree; 0.5% second-degree). The patient was discharged at 6 hours post-dose in 97% of episodes and required extended monitoring in 3%. In 5 episodes overnight monitoring was required. There were no episodes in which the patient required pharmacological intervention or temporary cardiac pacing.

Conclusions:
In this real-world UK population fingolimod initiation was predominantly uneventful; clinical observations were similar to previous clinical trials.

Labels: Study