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BMC Neurology

, 17:11

Demyelinating diseases

Abstract

BackgroundFirst dose observation for cardiac effects is required for fingolimod, but recommendations on the extent vary. This study aims to assess cardiac safety of fingolimod first dose. Individual bradyarrhythmic episodes were evaluated to assess the relevance of continuous electrocardiogram ECG monitoring.

MethodsSTART is an ongoing open-label, multi-center study. At the time of analysis 3951 patients were enrolled. The primary endpoints are the incidence of bradycardia heart rate < 45 bpm and second-third-degree AV blocks during treatment initiation. The relevance of Holter was assessed by matching ECG findings with the occurrence of clinical symptoms as well as by rigorous analysis of AV blocks with regard to the duration of pauses and the minimal heart rate recorded during AV block.

ResultsThirty-one patients 0.8% developed bradycardia <45 bpm, 62 patients 1.6% had second-degree Mobitz I and-or 2:1 AV blocks with a lowest reading i.e. mean of ten consecutive beats of 35 bpm and the longest pause lasting for 2.6 s. No Mobitz II or third-degree AV blocks were observed. Only one patient complained about mild chest discomfort and fatigue. After 1 week, there was no second-third-degree AV block.

ConclusionsContinuous Holter ECG monitoring in this large real-life cohort revealed that bradycardia and AV conduction abnormalities were rare, transient and benign. No further unexpected abnormalities were detected. The data presented here give an indication that continuous Holter ECG monitoring does not add clinically relevant value to patients’ safety.

Trial registrationNCT01585298; registered April 23, 2012.

KeywordsFingolimod First dose Electrocardiogram Cardiac effects Bradycardia Atrioventricular conduction AbbreviationsAEAdverse event

AVAtrioventricular conduction

DSMBData Safety Monitoring Board

ECGElectrocardiogram

EDSSExpanded Disability Status Scale

EUEuropean Union

EUDRACTEuropean Clinical Trials Database

FTY720Fingolimod

RRMSRelapsing remitting multiple sclerosis

S1PSphingosine-1-phosphate

SAESerious adverse event

SDStandard deviation

USUnited States

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Autor: Volker Limmroth - Tjalf Ziemssen - Michael Lang - Stephan Richter - Bert Wagner - Judith Haas - Stephan Schmidt - Kathrin 

Fuente: https://link.springer.com/



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