Abstract | PURPOSE: METHODS: An open label trial providing class IV evidence of efficacy, including 32 patients with cryptogenic/symptomatic, generalized or multifocal epilepsies, and refractory drop attacks. Following baseline, the combination under study was introduced and patients followed for 12 months. Frequency of drop attacks was compared at 3-month intervals with that during baseline and correlated with clinical, electroencephalography (EEG), and imaging variables. A list of putative side effects was read to patients and caregivers at each visit. KEY FINDINGS: Four patients were excluded, one due to a Stevens-Johnson syndrome (SJS). Median number of drop attacks decreased 96% between baseline and the fourth trimester of the study (from 50 to 2; p<0,001). Intention-to-treat (ITT) analysis showed that 15 patients (47%) had complete control, 7 (21%) had a 75% and 5 (15%) had a 50-74% reduction in the frequency of falls in the fourth trimester. Twenty-two patients (68%) had side effects, but except for the three excluded because of early rash, caregivers did not consider discontinuation. Mean final dose of valproate was 35.9 mg/kg/day and that of lamotrigine 4.9 mg/kg/day. Twenty patients used clobazam, eight nitrazepam, and the other four clonazepam as the elected benzodiazepine. Outcome did not correlate with clinical, EEG, and imaging variables. SIGNIFICANCE:
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Authors | Vitor Hugo Machado, Andre Palmini, Fernanda Almeida Bastos, Rosana Rotert |
Journal | Epilepsia
(Epilepsia)
Vol. 52
Issue 7
Pg. 1303-10
(Jul 2011)
ISSN: 1528-1167 [Electronic] United States |
PMID | 21729037
(Publication Type: Clinical Trial, Journal Article)
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Copyright | Wiley Periodicals, Inc. © 2011 International League Against Epilepsy. |
Chemical References |
- Anticonvulsants
- Triazines
- Benzodiazepines
- Valproic Acid
- Lamotrigine
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Topics |
- Adolescent
- Adult
- Anticonvulsants
(administration & dosage, therapeutic use)
- Benzodiazepines
(administration & dosage, therapeutic use)
- Child
- Child, Preschool
- Drug Therapy, Combination
- Electroencephalography
- Epilepsy
(drug therapy, prevention & control)
- Female
- Humans
- Lamotrigine
- Male
- Middle Aged
- Syncope
(drug therapy, prevention & control)
- Triazines
(administration & dosage, therapeutic use)
- Valproic Acid
(administration & dosage, therapeutic use)
- Young Adult
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