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Abstract
Objective: Children born to women with epilepsy (WWE), exposed in utero to levetiracetam (LEV, n = 51), were assessed for early cognitive development and compared to children exposed to sodium valproate in utero (VPA, n = 44) and a group of children representative of the general population (n = 97).
Methods: Children were recruited prospectively from 2 cohorts in the United Kingdom and assessed using the Griffiths Mental Development Scale (1996), aged <24 months. Information regarding maternal demographics were collected and controlled for. This is an observational study with researchers not involved in the clinical management of the WWE.
Results: On overall developmental ability, children exposed to LEV obtained higher developmental scores when compared to children exposed to VPA (p < 0.001). When compared, children exposed to LEV did not differ from control children (p = 0.62) on overall development. Eight percent of children exposed to LEV in utero fell within the below average range (DQ score of <84), compared with 40% of children exposed to VPA. After controlling for maternal epilepsy and demographic factors using linear regression analysis, exposure to LEV in utero was not associated with outcome (p = 0.67). Conversely, when compared with VPA exposure, LEV exposure was associated with higher scores for the overall developmental quotient (p < 0.001).
Conclusion: Children exposed to LEV in utero are not at an increased risk of delayed early cognitive development under the age of 24 months. LEV may therefore be a preferable drug choice, where appropriate, for WWE prior to and of childbearing age.
Footnotes
Study funding: Sponsored by UCB. Work carried out by the UK Epilepsy and Pregnancy Register is supported by a research grant from the Epilepsy Research Foundation and a number of unrestricted educational grants from pharmaceutical companies (GlaxoSmithKline, Sanofi-Aventis, UCB, Janssen-Cilag, Novartis, Pfizer Inc., Eisai Inc.). A Web site detailing the aims of the UK Epilepsy and Pregnancy Register was made possible by a grant from GlaxoSmithKline and UCB. The work presented is also in part a programme (RP-PG-0606-1062) that received financial support from the National Institute for Health Research (NIHR) Programme Grants for Applied Research funding scheme. The Liverpool and Manchester Neurodevelopment Group have received an educational grant from Sanofi-Aventis and have received support from the NEAD study National Institute of Health Grant (2 R01 NS038455) and also by grants from Epilepsy Research UK RB219738 (National Lottery Charities Board). The views and opinions expressed within this article do not necessarily reflect those of the NIHR or the Department of Health.
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- AED
- antiepileptic drug
- CM
- congenital malformation
- GMDS
- Griffiths Mental Development Scale
- LEV
- levetiracetam
- LMNDG
- Liverpool and Manchester Neurodevelopment Group
- NART
- National Adult Reading Test
- SES
- socioeconomic status
- UKEPR
- UK Epilepsy and Pregnancy Register
- VPA
- valproate
- WWE
- women with epilepsy.
- Received May 28, 2010.
- Accepted September 24, 2010.
- Copyright © 2011 by AAN Enterprises, Inc.
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