Abstracts

Rationale: The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study is an NIH-funded, prospective, observational, multi-center investigation of pregnancy outcomes for both the mother and child. The MONEAD study will enroll 550 women (350 pregnant women with epilepsy (PWWE), 100 pregnant women without epilepsy, and 100 non-pregnant women with epilepsy). As the study approaches the enrollment target for PWWE, analysis of the distribution of AEDs can be informative about prescribing practices for PWWE at U.S. tertiary epilepsy centers.Methods: The MONEAD study began enrollment in December 2012. Twenty clinical sites from various geographic regions across the US were selected that have a focus on management of women with epilepsy during childbearing years. Twelve sites had successfully participated in our prior Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study. Inclusion criteria for PWWE include ages 14-45 years and up to 20 weeks gestational age. Exclusion criteria included history of psychogenic non-epilepsy spells, expected IQ<70, other major medical illness, progressive cerebral disease, and history of switching AEDs prior to enrollment. Unlike the NEAD study, MONEAD was specifically designed to enroll all PWWE regardless of treatment regimen.Results: As of May 26, 2015, 289 PWWE have been enrolled in the MONEAD study. At the time of enrollment, 211 (73.0%) were on monotherapy, 63 (21.8%) on polytherapy, and 15 (5.2%) on no AEDs. Of the AED monotherapy regimens, the most common were lamotrigine (43.6%), levetiracetam (36.0%), carbamazepine (5.7%), oxcarbazepine (4.3%), zonisamide (4.3%), and topiramate (3.3%). All other individual monotherapies were <1%. For AED polytherapy combinations, the most common were lamotrigine and levetiracetam (46.0%), lamotrigine and zonisamide (6.3%), and the remaining specific combinations were all <5%. Polytherapy was dual therapy for most, with only 7.9% on >3 AEDs. For all PWWE, only two subjects (0.7%) were on valproic acid (VPA) (1 monotherapy, 1 polytherapy).Conclusions: The distribution of AED types in monotherapy and polytherapy combinations likely reflects current prescribing patterns for pregnant women with epilepsy cared for in U.S. tertiary epilepsy centers. Lamotrigine and levetiracetam are the most commonly prescribed AEDs in monotherapy and as a dual-therapy combination. The low rates of VPA prescriptions is remarkable and is likely due to dissemination of information about the excessively high risks for structural teratogenicity and adverse neurodevelopmental outcomes, including autism. Polytherapy AED regimens may be chosen in an attempt to minimize VPA use and are supported by reports from pregnancy registries about the relatively low risk for major congenital malformations for some combinations. However, maternal outcomes and neurodevelopmental effects are not yet known but will be examined in the MONEAD study. Future analyses will include AED prescriptions by seizure types, frequency, and other epilepsy factors. Study supported by: NIH NINDS #2U01-NS038455.