Abstracts

Established in 1999, the Australian Registry enrolls women with epilepsy treated with AEDs, untreated women with epilepsy and those taking AEDs for other indications. It is a centralized observational study, with ethical committee approval and patient consent. Here we report the five year data from the Registry. Four telephone interviews are conducted, and patients are enrolled prospectively as well as retrospectively. To date 830 women have contacted the registry, 630 have been enrolled, 565 pregnancies reached completion, including 10 sets of twins. There were 165 patients on valproate (VPA), 209 on CBZ , 129 on LTG , and 38 on PHT. The indication for the AED was predominantly for epilepsy (542 out of 555 women). Folic acid intake preconception was noted in 378.Truly prospective enrolment comprised 233, prospective 252 and retrospective 80 patient. Primary generalized epilepsy was present in 253 women, partial in 266, the remainder were unclassified. Live births with no defects comprised 89%, live births with defect 5%, spontaneous abortions 3%, stillbirths, induced abortion with defect and lost to follow-up 1% each. The categories of malformations comprised neurological (12), cardiac (11), craniofacial (7), skeletal (15) and genitourinary (15). Drug therapy with valproate had a significant increase over untreated patients in the incidence of malformations: in monotherapy (16.1%) vs. untreated. patients (2.5%: p[lt]0.05). On further analysis it was striking that the increase in VPA treated patients was related to dose, with greater than1100 mg per day associated with a high risk, (p[lt] 0001). Lamotrigine was not associated with a single defect in monotherapy (61 patients), carbamazepine and phenytoin were similarly not significantly different from untreated patients. All seizure types were observed more frequently when patients were taking lamotrigine, than compared to VPA. The incidence of convulsive seizures was 5.3.% on VPA and 21,.3% on LTG (P[lt] 0.0029). Seizure control on carbamazepine was not significantly different from VPA. Seizure control did not appear to related to teratogenicy , but did contribute to foetal loss. The Registry is providing important information regarding pharmacotherapy for women who are pregnant or planning to become pregnant. The most striking finding is the relationship to higher dose VPA ([gt]1100 mg) with a markedly increase risk of fetal malformations. However, it is also important to not that VPA was associated with better seizure control that other drugs. (Supported by Unrestricted research grants from The Epilepsy Society of Australia, Sanofi Synthelabo, Novartis, Janssen-Cilag, GlaxoSmithKline, UCB and Pfizer.)