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Efficacy and Tolerability of Vigabatrin in Children with Refractory Partial Seizures: A Single‐Blind Dose‐Increasing Study
Author(s) -
Bernardina Bernardo Dalla,
Fontana E.,
Vigevano F.,
Fusco L.,
Torelli D.,
Galeone D.,
Buti D.,
Cianchetti C.,
Gnanasakthy A.,
Iudice A.
Publication year - 1995
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1157.1995.tb01047.x
Subject(s) - vigabatrin , tolerability , placebo , refractory (planetary science) , medicine , epilepsy , anticonvulsant , phenytoin , anesthesia , partial seizures , central nervous system disease , pediatrics , adverse effect , psychiatry , alternative medicine , physics , pathology , astrobiology
Summary: The efficacy and tolerability of vigabatrin (VGB) in children with refractory partial epilepsy were assessed in a single‐blind, add‐on, fixed‐sequence, placebo‐controlled trial. After 1‐month observation, the patients entered a 7‐month treatment period that involved administration of placebo for 1 month followed by VGB at the initial dosage of 40 mg/kg/day, to be increased to 60 and 80 mg/kg/day at 2‐month intervals if seizures persisted. Of the 46 children enrolled in the study, 7 dropped out prematurely due to lack of efficacy of the drug (n = 6) or increased seizure frequency (n = 1). In 11 patients who either became seizure‐free (n = 3) or improved markedly (n = 8), treatment was completed at a dose <80 mg/kg/day. The average number of seizures per month in the 39 patients who completed the study decreased from 97 during placebo to 21,12, and 9 after 2, 4, and 6 months of VGB treatments respectively (p < 0.0001 at each time). Response to VGB remained statistically significant when dropouts were included in the evaluation. The number of patients who had <50% reduction in seizure frequency after 2, 4, and 6 months was 28, 33, and 35, respectively. Eight patients became seizure‐free during the last 2 months of VGB treatment (3 at 40, 3 at 60, and 2 at 80 mg/kg/day, as compared with none during placebo treatment). Serum levels of associated antiepileptic drugs (AEDs) showed no signscant changes, except for serum phenytoin (PHT) concentration, which significantly (p < 0.01) decreased after VGB treatment. Increased appetite and sedation were observed in 17 and 11% of cases, respectively. VGB is effective in the management of refractory partial epilepsy in children, and in some patients a positive dose‐response relationship appears to occur over the assessed dosing range.