Universität zu Köln

Meissner, Axel and Limmroth, Volker (2016). Update on the cardiovascular profile of fingolimod in the therapy of relapsing-remitting multiple sclerosis (MS). Mult. Scler. Relat. Disord., 8. S. 19 - 27. OXFORD: ELSEVIER SCI LTD. ISSN 2211-0356

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Abstract

Background: Fingolimod (FTY720) has been approved as the first oral representative of the class of sphingosine-1-phosphate (SIP) receptor modulators for the treatment of relapsing-remitting multiple sclerosis (MS). Besides inducing vaso-relaxation, fingolimod can also influence electrical conduction in the myocardium and vascular endothelium by having a transient negative chronotropic effect on the sinus node. Methods: Cardiac safety and tolerability of fingolimod in the cardiac sense were reviewed by analysing the data collected from the FREEDOMS and TRANSFORMS studies-both relevant studies for marketing authorisation, from their extension studies, as well as the clinical data collected from a practice-related MS patient cohort with cardiovascular risk factors and corresponding co-medication (FIRST study). Results: The safety analyses on file gave no indication of any increased cardiovascular risk. The 23 mmHg increase in blood pressure observed after the first dose of fingolimod has no therapeutic consequences. The first dose of 0.5 mg fingolimod resulted in an average decrease in heart rate of 7-8 beats/min. The onset of effect occurred approximately 1-2 h after the first dose and the nadir was reached after approximately 4-5 h. This negative chronotropic effect returned to normal after internalisation of the S1P1 receptors on maintenance therapy. There were no indications that patients with cardiac risk factors required closer observation beyond the monitoring recommended by the EMA following the first dose of fingolimod. Case study observations from the routine clinical setting show that patients accept this method of monitoring, which they assess as being a positive aspect of attentive medical care and concern. (C) 2016 Elsevier B.V. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Meissner, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Limmroth, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-270347
DOI:	10.1016/j.msard.2016.04.002
Journal or Publication Title:	Mult. Scler. Relat. Disord.
Volume:	8
Page Range:	S. 19 - 27
Date:	2016
Publisher:	ELSEVIER SCI LTD
Place of Publication:	OXFORD
ISSN:	2211-0356
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ORAL FINGOLIMOD; FTY720; PHARMACOLOGY; INTERFERON; PHYSIOLOGY; RECEPTORS; EXTENSION; MYOCYTES; DISEASE; SAFETY Multiple languages Clinical Neurology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/27034