dc.contributor.author
Limmroth, Volker
dc.contributor.author
Dechend, Ralf
dc.contributor.author
Haverkamp, Wilhelm [u. v. a.]
dc.date.accessioned
2018-06-08T10:55:12Z
dc.date.available
2017-03-03T10:01:15.584Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/21334
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-24629
dc.description.abstract
Background First 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. Methods START 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. Results Thirty-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. Conclusions Continuous 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 registration NCT01585298; registered April 23, 2012.
en
dc.rights.uri
http://creativecommons.org/licenses/by/4.0/
dc.subject
Electrocardiogram
dc.subject
Cardiac effects
dc.subject
Atrioventricular conduction
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit
dc.title
Electrocardiographic assessments and cardiac events after fingolimod first
dose – a comprehensive monitoring study
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation
BMC Neurology. - 17 (2017), Artikel Nr. 11
dcterms.bibliographicCitation.doi
10.1186/s12883-016-0789-7
dcterms.bibliographicCitation.url
http://bmcneurol.biomedcentral.com/articles/10.1186/s12883-016-0789-7
refubium.affiliation
Charité - Universitätsmedizin Berlin
de
refubium.mycore.fudocsId
FUDOCS_document_000000026533
refubium.note.author
Der Artikel wurde in einer reinen Open-Access-Zeitschrift publiziert.
refubium.resourceType.isindependentpub
no
refubium.mycore.derivateId
FUDOCS_derivate_000000007833
dcterms.accessRights.openaire
open access