Abstract:
BACKGROUND:Fingolimod is approved by the U.S. Food and Drug Administration to reduce relapses and disability progression in relapsing forms of MS. Several screening studies and a first-dose observation (FDO) period are recommended due to adverse effects observed in clinical trials. OBJECTIVE:The objective of this study is to describe the early experience with fingolimod, including startup, tolerability and safety in a large academic multiple sclerosis (MS) center. METHODS:Patients prescribed fingolimod from September 2010 to July 2011 were identified through electronic medical records. Demographics, MS disease history, pre-treatment screening studies, FDO experience during shared medical visits and three month follow-up data were analyzed. RESULTS:Three hundred ninety-one patients were prescribed fingolimod of whom 317 started the medication and were included in the analysis. Fingolimod was most frequently used in relapsing remitting MS (n=256, 80.8%) and was prescribed as a first-line agent in 11 cases (3.5%). FDO was uneventful in 308 patients (96.8%). Adverse events during FDO were self limited and included symptomatic bradycardia (n=3), chest tightness (n=2) and hypertension (n=1). Fingolimod was discontinued in 30 patients (9.5%) at three months. Adverse effects leading to discontinuation by more than one patient included headache (n=4), macular edema (n=3), nausea (n=3) and hypertension (n=2). CONCLUSIONS:Fingolimod was well tolerated during FDO and adverse events were self limited. The shared medical visit is an appropriate setting for FDO. Adverse effects were similar to those described in clinical trials but the discontinuation rate was higher.
journal_name
J Neurol Scijournal_title
Journal of the neurological sciencesauthors
Ontaneda D,Hara-Cleaver C,Rudick RA,Cohen JA,Bermel RAdoi
10.1016/j.jns.2012.09.009subject
Has Abstractpub_date
2012-12-15 00:00:00pages
167-72issue
1-2eissn
0022-510Xissn
1878-5883pii
S0022-510X(12)00501-1journal_volume
323pub_type
杂志文章abstract::On December 31, 1988 there were 201 registered multiple sclerosis patients in Kuwait, an overall prevalence rate (PR) of 10.2 per 100,000; among them were 186 Arabs, of whom 72 were Palestinians and 51 Kuwaitis. Comparison of these two subgroups, who had a similar age distribution revealed that the disease was 2 1/2 t...
journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
pub_type: 杂志文章
doi:10.1016/j.jns.2011.03.022
更新日期:2011-06-15 00:00:00
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
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journal_title:Journal of the neurological sciences
pub_type: 杂志文章
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