PMID- 25877062
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150417
LR  - 20220331
IS  - 2211-0356 (Electronic)
IS  - 2211-0348 (Linking)
VI  - 3
IP  - 4
DP  - 2014 Jul
TI  - Fingolimod in relapsing multiple sclerosis: An integrated analysis of safety 
      findings.
PG  - 494-504
LID - S2211-0348(14)00031-5 [pii]
LID - 10.1016/j.msard.2014.03.002 [doi]
AB  - BACKGROUND: Fingolimod 0.5mg once daily is the first approved oral therapy for 
      relapsing multiple sclerosis (MS). OBJECTIVE: To report integrated long-term 
      safety data from phase 2/3 fingolimod studies. METHODS: Descriptive safety data 
      are reported from the FTY720 Research Evaluating Effects of Daily Oral Therapy in 
      Multiple Sclerosis (FREEDOMS) study, a 24-month, randomized, double-blind study 
      comparing fingolimod 0.5mg and 1.25mg with placebo, and an All Studies group 
      (patients who received fingolimod 0.5mg (n=1640) or 1.25-0.5mg (n=1776) in phase 
      2/3 studies and associated extensions). Relevant post-marketing experience, up to 
      December 2011, is included. RESULTS: The incidence of adverse events (AEs) and 
      serious AEs (SAEs) was similar with fingolimod and placebo in FREEDOMS. In the 
      All Studies group, fingolimod 0.5mg was associated with transient, rarely 
      symptomatic (0.5%), bradycardia and second-degree atrioventricular block on 
      treatment initiation, minor blood pressure increases, frequent (9%) but generally 
      asymptomatic liver enzyme elevations, and macular oedema (0.4%). The incidences 
      of infections (including serious and herpes infections), malignancies, SAEs and 
      treatment discontinuations due to AEs were similar with fingolimod 0.5mg and 
      placebo. CONCLUSION: The safety profile of fingolimod has been well characterized 
      in this large combined trial population. Although infrequent SAEs can occur, 
      there is no increased risk of infections, malignancies or serious cardiovascular 
      events versus placebo.
CI  - Copyright (c) 2014. Published by Elsevier B.V.
FAU - Kappos, Ludwig
AU  - Kappos L
AD  - Neurology, Department of Medicine, Clinical Research and Biomedicine, University 
      Hospital, Petersgraben 4, CH-4031 Basel, Switzerland. Electronic address: 
      ludwig.kappos@usb.ch.
FAU - Cohen, Jeffrey
AU  - Cohen J
AD  - Neurological Institute, The Mellen Center for Multiple Sclerosis Treatment and 
      Research, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, 
      USA.
FAU - Collins, William
AU  - Collins W
AD  - Novartis Pharma AG, CH-4056 Basel, Switzerland.
FAU - de Vera, Ana
AU  - de Vera A
AD  - Novartis Pharma AG, CH-4056 Basel, Switzerland.
FAU - Zhang-Auberson, Lixin
AU  - Zhang-Auberson L
AD  - Novartis Pharma AG, CH-4056 Basel, Switzerland.
FAU - Ritter, Shannon
AU  - Ritter S
AD  - Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 
      07849-1080, USA.
FAU - von Rosenstiel, Philipp
AU  - von Rosenstiel P
AD  - Novartis Pharma AG, CH-4056 Basel, Switzerland.
FAU - Francis, Gordon
AU  - Francis G
AD  - Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 
      07849-1080, USA.
LA  - eng
PT  - Journal Article
DEP - 20140325
PL  - Netherlands
TA  - Mult Scler Relat Disord
JT  - Multiple sclerosis and related disorders
JID - 101580247
OTO - NOTNLM
OT  - Adverse events
OT  - Cardiovascular events
OT  - Fingolimod
OT  - Multiple sclerosis
OT  - Pooled analysis
OT  - Safety
EDAT- 2015/04/17 06:00
MHDA- 2015/04/17 06:01
CRDT- 2015/04/17 06:00
PHST- 2013/12/05 00:00 [received]
PHST- 2014/02/28 00:00 [revised]
PHST- 2014/03/17 00:00 [accepted]
PHST- 2015/04/17 06:00 [entrez]
PHST- 2015/04/17 06:00 [pubmed]
PHST- 2015/04/17 06:01 [medline]
AID - S2211-0348(14)00031-5 [pii]
AID - 10.1016/j.msard.2014.03.002 [doi]
PST - ppublish
SO  - Mult Scler Relat Disord. 2014 Jul;3(4):494-504. doi: 10.1016/j.msard.2014.03.002. 
      Epub 2014 Mar 25.