Vigabatrin in the Treatment of Childhood Epilepsies: A Single‐Blind Placebo‐Controlled Study

Luna, David; Dulac, Olivier; Pajot, N; Beaumont, Daniel

doi:10.1111/j.1528-1157.1989.tb05322.x

Cited by 121 publications

(48 citation statements)

References 23 publications

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“…The rate of responders is slightly lower in our study where most patients were receiving VGB, a recently approved drug, which has demonstrated major efficacy in partial epilepsy in children (26)(27)(28)(29) and infants (30). Although used as a third-line therapy, STP showed one of the highest rates of efficacy for a new AED in an open study dedicated to partial seizures in pediatrics (30)(31)(32).…”

Section: Efficacy Of Stp In Childrenmentioning

confidence: 79%

Stiripentol: Efficacy and Tolerability in Children with Epilepsy

et al. 1999

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Summary:Purpose: Stiripentol (STP) is a new antiepileptic drug (AED) that inhibits cytochrome P,,,, resulting in increased plasma concentrations of concomitant AEDs. The efficacy and tolerability of STP as an add-on therapy in children were assessed.Methods: Two hundred twelve patients with refractory epilepsy, aged from 1 month to 20.5 years, received STP either in a single-blind, placebo-controlled trial (I08 patients) or in a further open trial (104 other patients selected by epilepsy syndrome for possible efficacy based on the results of the previous trial).Results: Among the 97 patients who could be analyzed for efficacy in the placebo-controlled study, the median seizure frequency was lower at 3 months with STP than with the placebo (p < 0.0001); 49% responded to the drug, including 10% who became seizure free. Patients with partial epilepsy had the highest response rate (57%). Results were confirmed in the open study where 68% of the 91 patients receiving STP responded at 3 months. These patients were mainly those with partial epilepsy (73%) who were receiving carbamazepine (CBZ) (75%) as comedication (p < 0.001). Ten of the 20 children with severe myoclonic epilepsy in infancy also responded with clobazam (CLB) as comedication. Efficacy was sustained long term in 74% of the 94 patients still receiving STP at a mean 30-month follow-up. Adverse events were reported in 48% of the 212 patients, mainly anorexia and loss of weight, but these events required STP discontinuation in only nine cases. Side effects were minimized in the open trial by optimizing the dose of comedication.Conclusions: STP seems to be a promising add-on drug, particularly when combined with CBZ in patients with partial childhood epilepsy refractory to vigabatrin (VGB) and with CLB in patients with severe myoclonic epilepsy in infancy.

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Section: Efficacy Of Stp In Childrenmentioning

confidence: 79%

Stiripentol: Efficacy and Tolerability in Children with Epilepsy

et al. 1999

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“…31 Results from an open multicenter trial in children have suggested that vigabatrin also could be useful in refractory epilepsies with generalized seizures, such as West syndrome.32 Chiron et all' have evaluated the results of &dquo;addon&dquo; treatment with vigabatrin in 68 patients with West syndrome. In 43% of the patients, there was a complete cessation of infantile spasms 5 months after initiating treatment.…”

Section: Discussionmentioning

confidence: 97%

Vigabatrin as a First-Choice Drug in the Treatment of West Syndrome

et al. 2000

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This is a prospective study designed to evaluate the efficacy and safety of vigabatrin as first-choice monotherapy in infants with West syndrome. One hundred sixteen patients with newly diagnosed West syndrome were studied in Argentina, from June 1994 to April 1998. The follow-up ranged from 17 to 40 months (mean, 23 months). Vigabatrin was administered upon diagnosis, starting with a 50-mg/kg/day dose and increasing 50 mg/kg every 48 hours to reach a maximum dose of 200 mg/kg/day. Twenty-nine percent of cases were considered to be cryptogenic or idiopathic West syndrome, while 70.7% were symptomatic. Response to vigabatrin treatment was measured according to five categories: (1) seizures free: 61.8% of cases for cryptogenic and 29.3% for symptomatic West syndrome, (2) more than 75% reduction in the number of infantile spasms: 14.7% for cryptogenic and 26.8% for symptomatic West syndrome, (3) from 50% to 74% reduction in the number of infantile spasms: 11.8% for cryptogenic and 24.4% for symptomatic West syndrome, (4) poor or null response: 11.8% for cryptogenic and 18.3% for symptomatic West syndrome, and (5) increase in the number of infantile spasms: one symptomatic case (1.2%). All seizure-free cryptogenic cases showed normal neuropsychic development. The most effective dose of vigabatrin was 150 mg/kg of body weight per day. The most frequent adverse events were somnolence in 19 cases and irritability in 15 cases, but none required treatment interruption.

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“…Independent observations derived from open studies of efficacy and safety of VGB in children provide strong evidence that this drug can cause behavioral disturbances in children (83)(84)(85)(86)(87)(88). Agitation, aggressivity, irritability, or hyperactivity was reported in 9-30% of children after the addition of VGB.…”

Section: Case Reportsmentioning

confidence: 99%

Antiepileptic Drugs, Learning, and Behavior in Childhood Epilepsy

Bourgeois

1998

Epilepsia

133

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Summary:Cognitive and behavioral impairments are found more often among epileptic children than among their peers. The cause of these impairments is multifactorial. Identifying the relative contribution of antiepileptic drugs (AEDs) to these problems has been the object of a large number of clinical investigations. This area of research has been characterized by an unusually high number of methodological challenges and pitfalls. Accordingly, results have often been inconsistent and contradictory, except for the more obvious observations that can be derived from clinical experience. Overall, the effects of AEDs on cognition and behavior in children have been overrated in the past. More recent research has benefited from the methodological lessons of previous studies and it suggests that the majority of children taking AEDs do not experience clinically relevant cognitive of behavioral adverse effects from these medications. In addition, some of the newer AEDs may indeed have a better cognitive profile. Nevertheless, clinical experience must be used to identify the subgroup of children who remain at risk for significant and clinically relevant cognitive and behavioral adverse effects of AEDs. Key Words: Epilepsy-Childhood-Antiepileptic drugs-IntelligenceBehavior.Among children and adolescents with epilepsy, the prevalence of cognitive and behavioral disorders is higher than among their nonepileptic peers. There are multiple underlying causes of these cognitive and behavioral abnormalities and they include factors related to the etiology of the epilepsy, ongoing seizure activity, genetics, and treatment, as well as psychosocial issues. It is often difficult to determine the relative contribution of any given factor. This complex interrelation has been the object of several reviews (1-10). Trying to assess the effects of antiepileptic drugs (AEDs) on learning and behavior in patients with epilepsy has revealed itself as being a considerable methodological challenge. The intent of the present review of these effects of AEDs in children with epilepsy is to go beyond an analysis of published neuropsychological investigations and to view the problem from the perspective of its practical relevance and of conventional wisdom in the clinical practice of pediatric epileptology. this area? (a) Undoubtedly, within a clinical practice, one will notice that a disproportionate percentage of children with epilepsy have learning and behavioral problems. Sometimes, based on their time course, these problems can be attributed to antiepileptic medication, but more often the relationship is blurred or nonexistent and problems precede the introduction of the very first AED. (b) Parents of children whose AEDs are temporarily discontinued for the purpose of presurgical monitoring are at times amazed at how much more alert and more responsive their child has suddenly become. (c) However, the same observation is reported by parents of children who have become seizure-free following epilepsy surgery, but whose AED regimen is exactly the same...

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Vigabatrin in the Treatment of Childhood Epilepsies: A Single‐Blind Placebo‐Controlled Study

Cited by 121 publications

References 23 publications

Stiripentol: Efficacy and Tolerability in Children with Epilepsy

Stiripentol: Efficacy and Tolerability in Children with Epilepsy

Vigabatrin as a First-Choice Drug in the Treatment of West Syndrome

Antiepileptic Drugs, Learning, and Behavior in Childhood Epilepsy

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