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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:dateCreated |
1993-12-30
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pubmed:abstractText |
Felbamate (FBM) is a new antiepileptic drug (AED) that has been tested in open and controlled studies in patients with therapy-refractory partial-onset seizures. Proof of efficacy is based on results of five controlled studies (three with polytherapy and two with monotherapy). In two of the three polytherapy studies, a classic placebo crossover design was used. The third study used a novel design evaluating the efficacy of FBM in a placebo-controlled parallel design in patients completing an evaluation for epilepsy surgery. The primary efficacy variable in this study was the number of patients who experienced a fourth seizure before the end of the study. Forty-six percent of patients randomized to FBM stopped treatment prematurely because of a fourth seizure compared with 88% randomized to placebo. Two studies investigating the efficacy in monotherapy were performed. Both studies used an identical trial design comparing FBM with a low dosage of valproate (VPA). The efficacy of FBM was found to be superior to the low-dosage VPA for both studies. Open long-term follow-up studies have confirmed the long-term efficacy of FBM for up to 12 months. Overall, FBM was well tolerated in both poly- and monotherapy.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Anticonvulsants,
http://linkedlifedata.com/resource/pubmed/chemical/Phenylcarbamates,
http://linkedlifedata.com/resource/pubmed/chemical/Placebos,
http://linkedlifedata.com/resource/pubmed/chemical/Propylene Glycols,
http://linkedlifedata.com/resource/pubmed/chemical/Valproic Acid,
http://linkedlifedata.com/resource/pubmed/chemical/felbamate
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pubmed:status |
MEDLINE
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pubmed:issn |
0013-9580
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
34 Suppl 7
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
S25-9
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pubmed:dateRevised |
2007-11-15
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pubmed:meshHeading |
pubmed-meshheading:8243375-Adult,
pubmed-meshheading:8243375-Anticonvulsants,
pubmed-meshheading:8243375-Child,
pubmed-meshheading:8243375-Double-Blind Method,
pubmed-meshheading:8243375-Drug Therapy, Combination,
pubmed-meshheading:8243375-Epilepsies, Partial,
pubmed-meshheading:8243375-Epilepsy, Generalized,
pubmed-meshheading:8243375-Humans,
pubmed-meshheading:8243375-Phenylcarbamates,
pubmed-meshheading:8243375-Placebos,
pubmed-meshheading:8243375-Propylene Glycols,
pubmed-meshheading:8243375-Research Design,
pubmed-meshheading:8243375-Valproic Acid
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pubmed:year |
1993
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pubmed:articleTitle |
Felbamate in the treatment of refractory partial-onset seizures.
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pubmed:affiliation |
Schering-Plough Research Institute, Kenilworth, NJ 07033-0539.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Comparative Study,
Randomized Controlled Trial
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