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Abstract
Objective: Adverse effects (AEs) are a major concern when starting antiepileptic drug (AED) treatment. This study quantified the extent to which AE reporting in people with new-onset seizures started on AEDs is attributable to the medication per se, and investigated variables contributing to AE reporting.
Methods: We pooled data from 2 large prospective studies, the Multicenter Study of Early Epilepsy and Single Seizures and the Northern Manhattan Study of incident unprovoked seizures, and compared adverse event profile (AEP) total and factor scores between adult cases prescribed AEDs for new-onset seizures and untreated controls, adjusting for several demographic and clinical variables. Differences in AEP scores were also tested across different AED monotherapies and controls, and between cases and controls grouped by number of seizures.
Results: A total of 212 cases and 206 controls were identified. Most cases (94.2%) were taking low AED doses. AEP scores did not differ significantly between the 2 groups. Depression, female gender, symptomatic etiology, younger seizure onset age, ≥2 seizures, and history of febrile seizures were associated with higher AEP scores. There were no significant differences in AEP scores across different monotherapies and controls. AEP scores increased in both cases and controls with increasing number of seizures, the increment being more pronounced in cases.
Conclusions: When AED treatment is started at low doses following new-onset seizures, AE reporting does not differ from untreated individuals. Targeting specific factors affecting AE reporting could lead to improved tolerability of epilepsy treatment.
Footnotes
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Study funding: Supported by the Centers for Disease Control and Prevention (MM-0322) and the UK Research Medical Council (G9125317).
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- AE
- adverse effect
- AED
- antiepileptic drug
- AEP
- Adverse Event Profile
- CBZ
- carbamazepine
- DIS
- Diagnostic Interview Schedule
- DISC
- Diagnostic Interview Schedule for Children
- DSM-IV
- Diagnostic and Statistical Manual of Mental Disorders, 4th edition
- HADS
- Hospital Anxiety and Depression Scale
- LEV
- levetiracetam
- LTG
- lamotrigine
- MESS
- Multicenter Study of Early Epilepsy and Single Seizures
- NMS
- Northern Manhattan Study
- PHT
- phenytoin
- VPA
- valproic acid.
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Disclaimer: The findings and conclusions in the report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
- Received May 10, 2010.
- Accepted September 17, 2010.
- Copyright © 2011 by AAN Enterprises, Inc.
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