Effects of Differing Dosages of Vigabatrin (Sabril) on Cognitive Abilities and Quality of Life in Epilepsy

Dodrill, Carl B.; Arnett, John L.; Sommerville, Kenneth W.; Sussman, Neil M.

doi:10.1111/j.1528-1157.1995.tb00976.x

Cited by 87 publications

(32 citation statements)

References 23 publications

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“…Patients who attained TGB monotherapy improved in the areas of adjustment and mood (67), a change attributable most likely to discontinuation of previous AEDs. Similarly, several investigations of the cognitive and behavioral effects of VGB have shown no or only minimal impairment, and even some evidence of improvement (68)(69)(70)(71)(72). Psychosis and depression have been repeatedly described with VGB, both in adults and in children (73)(74)(75).…”

Section: Newer Aedsmentioning

confidence: 93%

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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Section: Newer Aedsmentioning

confidence: 93%

Antiepileptic Drugs, Learning, and Behavior in Childhood Epilepsy

Bourgeois

1998

Epilepsia

133

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“…None of the studies reported a priori sample size calculation, and may potentially have been underpowered. In two trials, some doses of VGB exceeded the recommended limit, 153,168 and in three further studies, the number of participants completing the study was unclear. 51,152,169 In one of these, trials over 20% of follow-up data were classified as missing.…”

Section: Tgbmentioning

confidence: 99%

“…38,51,87,[152][153][154]168,169 Twenty-two studies were parallel superiority trials and 10 were crossover trials. No studies of adjunctive OXC reported QoL outcomes.…”

Section: Quality Of Lifementioning

confidence: 99%

Clinical effectiveness, tolerability and cost-effectiveness of newer drugs for epilepsy in adults: a systematic review and economic evaluation

Wilby¹,

Kainth²,

Hawkins³

et al. 2005

Health Technol Assess

199

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Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per monograph and for the rest of the world £3 per monograph.You can order HTA monographs from our Despatch Agents:-fax (with credit card or official purchase order) -post (with credit card or official purchase order or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you either to pay securely by credit card or to print out your order and then post or fax it. NHS libraries can subscribe free of charge. Public libraries can subscribe at a very reduced cost of £100 for each volume (normally comprising 30-40 titles). The commercial subscription rate is £300 per volume. Please see our website for details. Subscriptions can only be purchased for the current or forthcoming volume. Contact details are as follows: Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to Direct Mail Works Ltd and drawn on a bank with a UK address. Paying by credit cardThe following cards are accepted by phone, fax, post or via the website ordering pages: Delta, Eurocard, Mastercard, Solo, Switch and Visa. We advise against sending credit card details in a plain email. Paying by official purchase orderYou can post or fax these, but they must be from public bodies (i.e. NHS or universities) within the UK. We cannot at present accept purchase orders from commercial companies or from outside the UK. How do I get a copy of HTA on CD?Please use the form on the HTA website (www.hta.ac.uk/htacd.htm). Or contact Direct Mail Works (see contact details above) by email, post, fax or phone. HTA on CD is currently free of charge worldwide.The website also provides information about the HTA Programme and lists the membership of the various committees. HTA NHS R&D HTA ProgrammeT he research findings from the NHS R&D Health Technology Assessment (HTA) Programme directly influence key decision-making bodies such as the National Institute for Clinical Excellence (NICE) and the National Screening Committee (NSC) who rely on HTA outputs to help raise standards of care. HTA findings also help to improve the quality of the service in the NHS indirectly in that they form a key component of the 'National Knowledge Service' that is being developed to improve the evidence of clinical practice throughout the NHS.The HTA Programme was set up in 1993. Its role is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined to include all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care, rather than settings of care.The HTA programme commissions research only on topics where it has identified key gaps in the evidence needed by the NHS. Suggestions for topics are actively sought from people working in the NHS, the public...

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“…The instrument has been validated against external criteria, including professional and significant-other ratings of psychosocial functioning (27). It has also been translated into several languages (37-41) and used as an outcome measured in several clinical trials (20)(21)(22). Although the WPSI contains subscales that reflect many of the domains of HRQL, it was constructed as a measure of psychological and social adjustment in persons with epilepsy.…”

Section: Resultsmentioning

confidence: 99%

Evaluating Health‐Related Quality of Life Outcomes in Clinical Trials of Antiepileptic Drug Therapy

Leidy¹,

Rentz²,

Grace

1998

Epilepsia

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Summary: Purpose:To provide an overview of conditionspecific health-related quality of life (HRQL) assessment in clinical trials of antiepileptic drug (AED) therapy in adults. We describe the key measurement issues in HRQL evaluation, identify the instruments that have been used in this population, summarize the psychometric characteristics of these instruments, propose areas of HRQL most likely to change with treatment, and offer recommendations for further research.Methods: We conducted a comprehensive review of the literature using repeated searches of the MEDLINE database together with a review of reference lists from published papers. Psychometric information on the instruments was gathered from published literature.Results: Three epilepsy-specific HRQL measures were identified: the Epilepsy-Surgery Inventory (ESI-55), the Liverpool Assessment Battery, and the Quality of Life in Epilepsy Inventory (QOLIE, the 89-, 31-, and 10-item versions). One new measure, the Epilepsy Foundation of America (EFA) Concerns Index was also found. The psychometric characteristics of these The social and psychological consequences of epilepsy are numerous. Patients often describe social stigma and the fear that friends who discover they have epilepsy or witness a seizure will change their behavior or withdraw their friendship or support. Self-imposed social isolation can be intensified by restrictions on driving, which are tied by law to seizure-free periods and by treatment side effects, which can interfere with day-to-day activities (1). Men and women with epilepsy also experience limitations in employment opportunities, including restraints on physical labor such as machine or power tool operation, and constraints in upward mobility due to concern that the stress involved could contribute to an increase in seizure activity. Difficulty in obtaining health, life, and automobile insurance can be a financial burden and an additional source of stress. Together, these diffiAccepted April 6, 1998 Address correspondence and reprint requests to Dr. N. Kline Leidy at MEDTAP International, Inc., 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, U.S.A. instruments are discussed in relationship to performance or expected performance in a clinical trial setting. A review of descriptive studies and trials to date suggests that subscales reflecting the psychological and social domains of HRQL may be most sensitive to treatment designed to increase seizure-free periods, reduce seizure severity, and minimize undesirable side effects.Conclusions: Although evaluation of HRQL outcomes in clinical trials of epilepsy is still in its infancy, several reliable and valid condition-specific measures are available for understanding the impact of disease and treatment on HRQL. Further research is needed to determine minimal clinically important change scores and to assess the psychometric stability of measures across cultures and mode of administration (self, interview, telephone). Studies of patient preferences for health outcomes in the form of u...

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Effects of Differing Dosages of Vigabatrin (Sabril) on Cognitive Abilities and Quality of Life in Epilepsy

Cited by 87 publications

References 23 publications

Antiepileptic Drugs, Learning, and Behavior in Childhood Epilepsy

Antiepileptic Drugs, Learning, and Behavior in Childhood Epilepsy

Clinical effectiveness, tolerability and cost-effectiveness of newer drugs for epilepsy in adults: a systematic review and economic evaluation

Evaluating Health‐Related Quality of Life Outcomes in Clinical Trials of Antiepileptic Drug Therapy

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