Joe Datt1, Laura Baldock2, Emily Pull3, Bryn Webber4. 1. Novartis Pharmaceuticals, Frimley Business Park, Frimley, Camberley, United Kingdom. Electronic address: joedatt@doctors.org.uk. 2. pH Associates Ltd, Derwent House, Dedmere Road, Marlow, United Kingdom. Electronic address: laurabaldock@phassociates.com. 3. Novartis Pharmaceuticals, Frimley Business Park, Frimley, Camberley, United Kingdom. Electronic address: emily.pull@novartis.com. 4. Regent's Park Heart Clinics (RPHC), 52 Brook Street, Mayfair, London, United Kingdom. Electronic address: bryn.webber@regentsparkhealthcare.com.
Abstract
BACKGROUND: Patients initiated on Gilenya (fingolimod) require cardiovascular monitoring for 6h 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 6h 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 5h (the lowest recorded HR) and 66.1 bpm at 6h 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.
BACKGROUND:Patients initiated on Gilenya (fingolimod) require cardiovascular monitoring for 6h 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 6h 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 5h (the lowest recorded HR) and 66.1 bpm at 6h 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.
Authors: Brandon Brown; Jamie L Weiss; Scott Kolodny; Xiangyi Meng; Ian M Williams; John A Osborne Journal: BMC Neurol Date: 2019-11-15 Impact factor: 2.474