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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
5
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pubmed:dateCreated |
1993-10-26
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pubmed:abstractText |
A double-blind, randomized, cross-over study of additional vigabatrin (gamma-vinyl-GABA, VGB, 1.0 g twice daily for 6 weeks, followed by 1.5 g twice daily for 6 weeks) and matched placebo was undertaken in 24 patients with refractory epilepsy. Nineteen completed the trial satisfactorily. Fewer seizure days were reported during VGB treatment [placebo 41, VGB 23, p < 0.05, 95% confidence interval (CI) -1.5 to -14]. An overall reduction in median seizure numbers failed to reach statistical significance (n = 19; placebo 52, VGB 32, NS, 95% CI -18 to +24). Subgroup analysis, however, showed a significant reduction in partial seizures (n = 17) with 2 g VGB daily (placebo 22, VGB 13, p < 0.05, 95% CI -0.5 to -16.5), but not with higher dosage (placebo 28, VGB 22, NS, 95% CI -18 to +11). A deterioration in control of partial seizures as compared with the equivalent placebo phase was observed when patients were changed from 2 to 3 g/day VGB (2 g VGB 13, 3 g VGB 22, p = 0.05, 95% CI 0 to +20). Loss of efficacy was noted in 3 patients, and seizure control worsened slightly in 5 others. One previously resistant patient developed a therapeutic response, and 2 other patients reported an additional useful reduction in seizures. In the remaining 8 patients, seizure frequency did not change. VGB did not appear to benefit tonic-clonic seizures. Serum VGB concentrations were higher during treatment with 3 g (15.5 +/- 8.9 mg/L) daily than with 2 g (13.5 +/- 11.2 mg/L). No important alterations were noted in the concentrations of concomitantly administered antiepileptic drugs (AEDs) throughout the trial. VGB is useful adjuvant therapy for treatment of partial seizures. There may be a ceiling to effective dosage. This demands individual dose titration for each patient.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
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
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
937-43
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pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:8404750-Adolescent,
pubmed-meshheading:8404750-Adult,
pubmed-meshheading:8404750-Aminocaproic Acids,
pubmed-meshheading:8404750-Anticonvulsants,
pubmed-meshheading:8404750-Double-Blind Method,
pubmed-meshheading:8404750-Drug Administration Schedule,
pubmed-meshheading:8404750-Drug Therapy, Combination,
pubmed-meshheading:8404750-Epilepsies, Partial,
pubmed-meshheading:8404750-Epilepsy,
pubmed-meshheading:8404750-Female,
pubmed-meshheading:8404750-Humans,
pubmed-meshheading:8404750-Male,
pubmed-meshheading:8404750-Middle Aged,
pubmed-meshheading:8404750-Placebos,
pubmed-meshheading:8404750-Treatment Outcome,
pubmed-meshheading:8404750-Vigabatrin
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pubmed:articleTitle |
Adjuvant vigabatrin in refractory epilepsy: a ceiling to effective dosage in individual patients?
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pubmed:affiliation |
University Department of Medicine and Therapeutics, Western Infirmary, Glasgow, Scotland.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't
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