Abstracts

EURAP aims at comparing risks of major malformations following intake of antiepileptic drugs (AEDs) in pregnancy. EURAP builds on networks of reporting physicians in Europe, Asia, Oceania and South America. Women taking AEDs at the time of conception are eligible for inclusion. Only pregnancies registered before foetal outcome is known and within week 16 of gestation contribute to the prospective study. Information on drug therapy and other potential risk factors is collected prospectively online each trimester, at birth and at one year after delivery. Foetal outcome is classified by a committee unaware of the type of drug exposure. By May 2004 physicians from 37 countries have reported more than 4,800 pregnancies to the Central Registry. By the time of the latest interim report November 2003, 2330 pregnancies meeting the inclusion criteria had been completed. Of these, 73% were prospective. There were 24 stillbirths, 16 perinatal deaths, 46 induced and 114 spontaneous abortions, and 1501 livebirths among the prospective pregnancies. 81% used a single AED,16% were on two AEDs. The most frequently used AEDs in monotherapy were carbamazepine (n=506), valproic acid (n=354), lamotrigine (n=228) and phenobarbital (n=115). Lamotrigine and valproic acid (n=41) and lamotrigine and carbamazepine (n=35) were the most common combinations. 98 cases with malformations have been identified, including 10 cases among induced abortions, two among stillbirths and three of the perinatal deaths. This represents a malformation rate of 6%. Of the birth defects, 65 were observed after monotherapy (4.7%) and 33 after polytherapy (10%). It should be emphasized that this is a preliminary classification of outcome based mainly on the follow-up three months after birth. A formal comparison of malformation rates between different AEDs will be made when sufficient statistical power has been obtained. Intensive on-line interaction between the central registry and reporting physicians has proven effective in ensuring enrolment and follow-up on an international basis. Comparative data on risks with the most frequently used treatments is expected to become available soon. (Supported by Presentation on behalf of the EURAP study group (www.eurapinternational.org)
Scientific Advisory Board: Bernd Schmidt and Martin J Brodie
Educational grants from GlaxoSmithKline, Janssen-Cilag, Novartis, Pfizer, Sanofi-Synthelabo, and UCB SA)