Universität zu Köln

Limmroth, Volker, Ziemssen, Tjalf ORCID: 0000-0001-8799-8202, Lang, Michael, Richter, Stephan, Wagner, Bert, Haas, Judith, Schmidt, Stephan, Gerbershagen, Kathrin, Lassek, Christoph, Klotz, Luisa, Hoffmann, Olaf, Albert, Christian, Schuh, Katrin, Baier-Ebert, Monika, Wendt, Guillaume, Schieb, Heinke, Hoyer, Susanne, Dechend, Ralf and Haverkamp, Wilhelm (2017). Electrocardiographic assessments and cardiac events after fingolimod first dose - a comprehensive monitoring study. BMC Neurol., 17. LONDON: BIOMED CENTRAL LTD. ISSN 1471-2377

Full text not available from this repository.

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Limmroth, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED Ziemssen, Tjalf UNSPECIFIED orcid.org/0000-0001-8799-8202 UNSPECIFIED Lang, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Richter, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Wagner, Bert UNSPECIFIED UNSPECIFIED UNSPECIFIED Haas, Judith UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Gerbershagen, Kathrin UNSPECIFIED UNSPECIFIED UNSPECIFIED Lassek, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Klotz, Luisa UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoffmann, Olaf UNSPECIFIED UNSPECIFIED UNSPECIFIED Albert, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Schuh, Katrin UNSPECIFIED UNSPECIFIED UNSPECIFIED Baier-Ebert, Monika UNSPECIFIED UNSPECIFIED UNSPECIFIED Wendt, Guillaume UNSPECIFIED UNSPECIFIED UNSPECIFIED Schieb, Heinke UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoyer, Susanne UNSPECIFIED UNSPECIFIED UNSPECIFIED Dechend, Ralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Haverkamp, Wilhelm UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-242404
DOI:	10.1186/s12883-016-0789-7
Journal or Publication Title:	BMC Neurol.
Volume:	17
Date:	2017
Publisher:	BIOMED CENTRAL LTD
Place of Publication:	LONDON
ISSN:	1471-2377
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language RELAPSING MULTIPLE-SCLEROSIS; INDUCED ATRIOVENTRICULAR-BLOCK; ORAL FINGOLIMOD; FTY720; DRUG; SAFETY; MANAGEMENT; CONDUCTION; INITIATION; RHYTHM Multiple languages Clinical Neurology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/24240