Journal article
Dose-dependent teratogenicity of valproate in mono-and polytherapy
T Tomson, D Battino, E Bonizzoni, J Craig, D Lindhout, E Perucca, A Sabers, SV Thomas, F Vajda
Neurology | Published : 2015
Abstract
Objective: To assess the risk of major congenital malformations (MCMs) in association with maternal use of valproic acid (VPA) in monotherapy or adjunctive therapy, and its relationship with dose. Methods: The analysis was based on prospectively acquired data from EURAP, a registry enrolling women treated with antiepileptic drugs (AEDs) in early pregnancy, in which the primary outcome is presence of MCMs at 1 year after birth. Exposure was defined as type and dose of AEDs at time of conception. A comparison was made among 3 exposure types: (1) VPA monotherapy (n 1,224); (2) VPA combined with lamotrigine (LTG) (n 159); and (3) VPA combined with another AED but not LTG (n 205). Results: The fr..
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Awarded by Netherlands Epilepsy Foundation (NEF)
Funding Acknowledgements
EURAP has received financial support from the following pharmaceutical companies: Bial, Eisai, GlaxoSmithKline, Novartis, UCB, Janssen-Cilag, Pfizer, and Sanofi-Aventis. The following pharmaceutical companies have continued to provide financial support after 2010: Bial, Eisai, GlaxoSmithKline, Novartis, and UCB. Further financial support has been provided from Netherlands Epilepsy Foundation (NEF) grant 03-18 (Dr. Lindhout) and from Stockholm County Council, ALF (Dr. Tomson). The funding organizations had no influence on the conduct of the study, analysis, interpretation, writing of the manuscript, or the decision to publish the results. The Australian Pregnancy Register has received funding from Sanofi/Genzyme, UCB, Janssen, SciGen, Eisai, Australian National Health and Medical Research Council, Epilepsy Society of Australia, Royal Melbourne Hospital Medical Research Foundation, and Epilepsy Action.