PMID- 27757552
OWN - NLM
STAT- MEDLINE
DCOM- 20170214
LR  - 20191210
IS  - 1590-3478 (Electronic)
IS  - 1590-1874 (Linking)
VI  - 38
IP  - 1
DP  - 2017 Jan
TI  - Safety and tolerability of fingolimod in patients with relapsing-remitting 
      multiple sclerosis: results of an open-label clinical trial in Italy.
PG  - 53-59
LID - 10.1007/s10072-016-2701-z [doi]
AB  - The safety profile of fingolimod is well established in clinical trials and 
      post-marketing studies. This study aimed to evaluate the safety and tolerability 
      of fingolimod in a cohort of Italian patients with relapsing-remitting multiple 
      sclerosis (RRMS). This is a non-comparative, open-label, multicentre, 
      interventional study conducted in patients with RRMS with no suitable alternative 
      treatment option. Safety and tolerability of fingolimod 0.5 mg were assessed by 
      recording adverse events (AEs) and serious AEs (SAEs). Of the 906 patients 
      enrolled in the study, 91 % of the patients completed the study. AEs and SAEs 
      were reported in 35.4 and 2.9 % of the patients, respectively. Most common AEs 
      reported were headache (4.1 %), influenza (2.1 %), lymphopenia (1.8 %), asthenia 
      (1.8 %) and pyrexia (1.8 %). Increased alanine aminotransferase levels and 
      hypertension were reported as AE in 1.0 and 1.4 % of the patients, respectively. 
      Macular oedema was reported in three patients. These results emphasize the safety 
      of fingolimod in patients representing the real-world clinical practice in the 
      Italian population. Fingolimod was safe and well tolerated in this population, 
      which, compared to those enrolled in pivotal trials in terms of concomitant 
      diseases and used medications, is broader. TRIAL REGISTRATION: EudraCT 
      2011-000770-60.
FAU - Laroni, Alice
AU  - Laroni A
AD  - Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and 
      Child Health, University of Genoa, Largo Daneo 3, 16132, Genoa, Italy.
AD  - IRCCS San Martino-IST, Genova, Italy.
AD  - Center of Excellence for Biomedical Research, Genova, Italy.
FAU - Brogi, Davide
AU  - Brogi D
AD  - Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and 
      Child Health, University of Genoa, Largo Daneo 3, 16132, Genoa, Italy.
FAU - Brescia Morra, Vincenzo
AU  - Brescia Morra V
AD  - Department of Neurological Sciences, University Federico II, Naples, Italy.
FAU - Guidi, Leonello
AU  - Guidi L
AD  - Neurology Unit, S. Giuseppe Hospital, Empoli, Italy.
FAU - Pozzilli, Carlo
AU  - Pozzilli C
AD  - Department of Neurology, University La Sapienza, Rome, Italy.
FAU - Comi, Giancarlo
AU  - Comi G
AD  - Department of Neurology, Scientific Institute, INSPE, Vita-Salute San Raffaele 
      University, Scientific Institute San Raffaele, Milan, Italy.
FAU - Lugaresi, Alessandra
AU  - Lugaresi A
AD  - Department of Neuroscience, Imaging and Clinical Sciences, University G. 
      d'Annunzio, Chieti, Italy.
FAU - Turrini, Renato
AU  - Turrini R
AD  - Novartis Farma, Origgio, Varese, Italy.
FAU - Raimondi, Debora
AU  - Raimondi D
AD  - Novartis Farma, Origgio, Varese, Italy.
FAU - Uccelli, Antonio
AU  - Uccelli A
AD  - Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and 
      Child Health, University of Genoa, Largo Daneo 3, 16132, Genoa, Italy.
AD  - IRCCS San Martino-IST, Genova, Italy.
AD  - Center of Excellence for Biomedical Research, Genova, Italy.
FAU - Mancardi, Giovanni Luigi
AU  - Mancardi GL
AUID- ORCID: 0000-0001-8427-118X
AD  - Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and 
      Child Health, University of Genoa, Largo Daneo 3, 16132, Genoa, Italy. 
      glmancardi@neurologia.unige.it.
AD  - IRCCS San Martino-IST, Genova, Italy. glmancardi@neurologia.unige.it.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20161018
PL  - Italy
TA  - Neurol Sci
JT  - Neurological sciences : official journal of the Italian Neurological Society and 
      of the Italian Society of Clinical Neurophysiology
JID - 100959175
RN  - 0 (Immunosuppressive Agents)
RN  - G926EC510T (Fingolimod Hydrochloride)
SB  - IM
MH  - Adult
MH  - Female
MH  - Fingolimod Hydrochloride/*adverse effects/therapeutic use
MH  - Headache/chemically induced
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects/therapeutic use
MH  - Infections/chemically induced
MH  - Italy
MH  - Macular Edema/chemically induced
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis, Relapsing-Remitting/*drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Fingolimod
OT  - Relapsing-remitting multiple sclerosis
OT  - Safety
OT  - Tolerability
EDAT- 2016/10/21 06:00
MHDA- 2017/02/15 06:00
CRDT- 2016/10/21 06:00
PHST- 2016/05/09 00:00 [received]
PHST- 2016/08/29 00:00 [accepted]
PHST- 2016/10/21 06:00 [pubmed]
PHST- 2017/02/15 06:00 [medline]
PHST- 2016/10/21 06:00 [entrez]
AID - 10.1007/s10072-016-2701-z [pii]
AID - 10.1007/s10072-016-2701-z [doi]
PST - ppublish
SO  - Neurol Sci. 2017 Jan;38(1):53-59. doi: 10.1007/s10072-016-2701-z. Epub 2016 Oct 
      18.