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Read about studies of Sabril: Intermediate

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New comprehensive downloadable medication sheet
  • Additional information on this drug and how to use it.
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If you visit PubMed (http://www.ncbi.nlm.nih.gov/pubmed/), a service of the National Library of Medicine, you can read summaries of studies that have tested Sabril as well as other reports about this medication. Medical searches should be performed under the generic name, which is vigabatrin.

Read more about how to find and understand information in PubMed.

A few recent articles and PubMed abstracts are listed below.

Optom Vis Sci. 2009 Jun;86(6):767-73.Visual fields in young children treated with vigabatrin. Agrawal S, Mayer DL, Hansen RM, Fulton AB.

PURPOSE: To evaluate white sphere kinetic perimetry (WSKP) as a test of the peripheral visual field in young children with a history of epilepsy and treatment with Vigabatrin (VGB). VGB is an antiepileptic medication that is associated with visual field constriction. METHODS: Thirty-one VGB patients and 10 control subjects, median age 6 years, were recruited. Visual field extent on the major oblique meridia was tested with a 6 degrees white sphere and WSKP, a method used by Quinn et al. to study field extent in children with retinopathy of prematurity. The same meridia were tested using Goldmann kinetic perimetry (GKP; 1.7 degrees target) in those who were capable. Monocular and binocular tests were conducted. Visual field extent for WSKP and GKP were compared in VGB patients and control subjects. RESULTS: Twenty-eight of 31 VGB patients were testable with binocular WSKP and their median visual field extents were smaller than controls. In 8 of 28 (29%) VGB patients, binocular field extents were smaller than the minimum in the control subjects. Monocular WSKP results did not differ between VGB patients and control subjects. Nine VGB patients were testable with both WSKP and GKP; visual field extents did not differ between tests. CONCLUSIONS: WSKP is feasible in VGB patients, even in those with developmental delays. WSKP has the potential to detect visual field constriction associated with VGB use.

2: Eur J Neurol. 2009 Apr;16(4):482-7. Multicenter long-term follow-up of children with idiopathic West syndrome: ACTH versus vigabatrin. Cohen-Sadan S, Kramer U, Ben-Zeev B, Lahat E, Sahar E, Nevo Y, Eidlitz T, Zeharia A, Kivity S, Goldberg-Stern H.

BACKGROUND AND PURPOSE: Long-term follow-up of children with idiopathic West syndrome (WS) treated with adrenocorticotropic hormone (ACTH) or vigabatrin. METHODS: Records of 28 normal magnetic resonance imaging (MRI) WS cases were reviewed for seizure development and cognitive outcome in relation to treatment type and lag. RESULTS: Average age at disease onset was 5.5 months, and average lag time to treatment was 25 days. Fourteen patients were treated with ACTH (eight early and six late), and 14 with vigabatrin (without delay). Response rates were 88% for ACTH and 80% for vigabatrin. Short-term outcomes for seizure cessation and electroencephalography normalization were identical between the groups. In the long-term, early ACTH treatment was better than the rest combined. Average follow-up time was 9 years. A normal cognitive outcome was achieved in 100% of the early-ACTH group, 67% of the late-ACTH group and 54% of the vigabatrin group (P = 0.03). Seizures subsequently developed in 54% of the vigabatrin group, in 33% of the late ACTH group, and 0% of the early ACTH group (P < 0.05). CONCLUSIONS: Idiopathic WS with normal MRI is associated with a good cognitive outcome. Early ACTH treatment, administered within 1 month, yields a better cognitive and seizure outcome than vigabatrin or late ACTH.

Cochrane Database Syst Rev. 2008 Jul 16;(3):CD007302. Vigabatrin for refractory partial epilepsy. Hemming K, Maguire MJ, Hutton JL, Marson AG.

BACKGROUND: Epilepsy is a common neurological condition which affects between 0.5% and 1% of the population. Approximately 30% of people with epilepsy do not respond to treatment with currently available drugs, and the majority of these people have partial epilepsy. Vigabatrin is an antiepileptic drug licensed for use in the treatment of refractory epilepsy. No major side effects associated with the use of vigabatrin were detected by initial randomised controlled trials of the drug. However, longer term observational studies have subsequently identified that its use is associated with asymptomatic visual field constriction. OBJECTIVES: The objective of this review is to synthesise evidence from short-term, randomised, placebo-controlled trials of vigabatrin. We summarise the effects of vigabatrin on seizures and short-term side effects when used as an add-on treatment for people with drug-resistant partial epilepsy. A review of longer term observational studies and estimates of proportions of patients developing visual field constrictions is currently being undertaken and results will be cited here in due course. SEARCH STRATEGY: We searched the Cochrane Epilepsy Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2008), MEDLINE (1950-March 2008), and reference lists of articles. We also contacted the manufacturers of vigabatrin (Hoechst Marion Roussel). SELECTION CRITERIA: We included randomised, double-blind, placebo-controlled, fully published trials of vigabatrin, in people with drug-resistant partial epilepsy. DATA COLLECTION AND ANALYSIS: Two review authors assessed trials for inclusion and extracted data. Primary analysis was by intention-to-treat (ITT). Outcomes evaluated included 50% or greater reduction in seizure frequency, treatment withdrawal and side effects observable in the short term. Results are presented on the relative risk (RR) scale with 95 or 99% confidence intervals (CI). MAIN RESULTS: Eleven suitable trials, testing doses between 1000 mg and 6000 mg, were identified and included in the analysis. There were 982 observations on 747 patients in the primary ITT analysis of treatment efficacy. Patients treated with vigabatrin were significantly more likely to obtain a 50% or greater reduction in seizure frequency compared with those treated with placebo (RR 2.58 (95% CI 1.87 to 3.57)). Those treated with vigabatrin were also significantly more likely to have treatment withdrawn (RR 2.49 (95% CI 1.05 to 5.88)), and more likely to experience a number of side effects, significantly so for fatigue or drowsiness. There was some evidence of small study effect bias, with smaller studies tending to report greater estimates of RR than larger studies. It is possible that the actual relative risk of obtaining 50% reduction in seizure frequency may therefore be less than that obtained by a meta-analysis of fully published studies. AUTHORS' CONCLUSIONS: This review of randomised controlled trials shows that vigabatrin can reduce seizure frequency in people with drug-resistant partial epilepsy. Short-term follow up of patients shows some side effects are associated with its use. Further analysis of longer term observational studies is required to evaluate how likely patients are to develop visual field defects, and whether such side effects are associated with dose and duration of drug use. Epilepsia. 2008 Jul;49(7):1186-91. Vigabatrin in the treatment of childhood epilepsy: a retrospective chart review of efficacy and safety profile. Camposano SE, Major P, Halpern E, Thiele EA.

PURPOSE: To review the efficacy, cognitive outcome and safety profile in children treated with vigabatrin (VGB) for infantile spasms (IS) and partial epilepsies related to tuberous sclerosis complex (TSC) and other etiologies. METHODS: Retrospective review of children followed in the Pediatric Epilepsy Program of Massachusetts General Hospital for Children between May 2001 and March 2006 who were treated with VGB. RESULTS: Eighty-four children were treated with VGB, 68 of them were treated for IS, and 59 were treated for partial seizures (PS). Etiology (TSC or other) was the only predictive factor for IS control with VGB (p < 0.0003). IS control was achieved in 73% of children with TSC and 27% of children with other etiologies (combined 56%). Partial onset seizures were controlled in 34% of all children, (17% seizure free,17%reduction in seizure frequency >50%) and no predictive factor was found. Shorter time from seizure onset to VGB treatment (p < 0.027) and longer total time on VGB (p < 0.045) was associated with better IQ-developmental quotient (DQ) outcome in children treated for IS, but not with IS control. Adverse events were seen in 13%. Electroretinogram and/or behavioral visual field (VF) testing was done in 52%. VGB was discontinued in one case due to abnormal electroretinogram (ERG) findings. CONCLUSION: We confirm the efficacy of VGB in the treatment of IS and PS in an American population. VGB may improve cognitive outcome in the absence of complete IS control, but this finding is of uncertain clinical significance. VGB was well tolerated, and ophthalmologic side effects were uncommon.

Neurotherapeutics. 2007 Jan;4(1):163-72. Vigabatrin. Wheless JW, Ramsay RE, Collins SD.

Refractory epilepsies such as infantile spasms (IS) and complex partial seizures (CPS) can have a severe negative impact on the neurological integrity and quality of life of affected patients, in addition to drastically increasing their risk of premature mortality. Early identification of potentially effective pharmacotherapy agents is important. Vigabatrin has been shown to be a generally well tolerated and effective antiepileptic drug (AED) in a wide variety of seizure types affecting both children and adults, particularly those with IS and CPS. A bilateral, concentric constriction of the peripheral visual field characterizes the visual field defect (VFD) associated with vigabatrin, well characterized by numerous studies. This peripheral VFD presents in 30-50% of patients with exposure of several years; however, most of these patients are asymptomatic. In well-controlled studies, the earliest onset in patients with CPS is 11 months and at 5 months in infants, with average onsets being more than 5 years and 1 year, respectively. Patients with a peripheral VFD retain an average 65 degrees of lateral vision (normal, 90 degrees). The fact that many patients never develop the vigabatrin-related peripheral VFD, despite long-term exposure at high doses, may support the hypothesis that the injury is an idiosyncratic adverse drug reaction (as opposed to a strict dose- or duration-dependent toxicity). Effective testing methods are available to aid in the early detection and management of the peripheral VFD. This article discusses issues of importance to clinical decision-making in the use of vigabatrin to assist the physician and patient in assessing the benefits of vigabatrin therapy and understanding the potential risks of the VFD and uncontrolled seizures.


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