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A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis
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A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis
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A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis
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Journal Article
A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis
2010
Overview
In this 24-month, randomized trial involving patients with relapsing–remitting multiple sclerosis, oral fingolimod reduced the rates of relapse and disability progression, as compared with placebo. Adverse events reported in patients treated with fingolimod included bradycardia, atrioventricular conduction block, macular edema, elevations in liver-enzyme levels, and mild hypertension.
In patients with relapsing–remitting multiple sclerosis, oral fingolimod reduced the rates of relapse and disability progression, as compared with placebo. Adverse events included bradycardia, atrioventricular conduction block, macular edema, elevations in liver-enzyme levels, and mild hypertension.
Fingolimod (FTY720) is an oral sphingosine-1-phosphate–receptor modulator
1
that is currently being evaluated for the treatment of multiple sclerosis. There is evidence that fingolimod acts by preventing lymphocyte egress from lymph nodes.
2
,
3
This leads to a reduced infiltration of potentially autoaggressive lymphocytes into the central nervous system.
4
,
5
Preclinical findings also suggest that fingolimod may promote neuroprotective and reparative processes within the central nervous system through modulation of sphingosine-1-phosphate receptors expressed on neural cells.
6
–
12
A 6-month, phase 2, placebo-controlled study
13
and its open-label extension study
14
showed sustained suppression, for up to 5 years, of both relapse and inflammatory activity . . .
Publisher
Massachusetts Medical Society
Subject
/ Adult
/ Arrhythmias, Cardiac - chemically induced
/ Biological and medical sciences
/ Female
/ Herpesviridae Infections - etiology
/ Herpesviridae Infections - mortality
/ Humans
/ Immunosuppressive Agents - administration & dosage
/ Immunosuppressive Agents - adverse effects
/ Immunosuppressive Agents - therapeutic use
/ Macular Edema - chemically induced
/ Male
/ Multiple Sclerosis, Relapsing-Remitting - drug therapy
/ Multiple Sclerosis, Relapsing-Remitting - pathology
/ Propylene Glycols - administration & dosage
/ Propylene Glycols - adverse effects
/ Propylene Glycols - therapeutic use
/ Sphingosine - administration & dosage
/ Sphingosine - adverse effects
/ Sphingosine - analogs & derivatives
