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 mother and child. The MONEAD study has completed enrollment of adult women. Enrollment of children born to the pregnant women, their fathers, and maternal relatives is still ongoing. Analysis of the distribution of AEDs can be informative about prescribing practices for pregnant women with epilepsy at U.S. tertiary epilepsy centers. Methods: MONEAD study enrollment began in December 2012. Twenty clinical sites across the US were selected that have a focus on management of women with epilepsy during childbearing years. Inclusion criteria for PWWE included 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 switching AEDs in pregnancy prior to enrollment. Unlike the NEAD study, MONEAD was specifically designed to enroll all PWWE regardless of treatment regimen. Results: 351 pregnant women with epilepsy (PWWE), 105 pregnant women without epilepsy, and 109 non-pregnant women with epilepsy were enrolled in the MONEAD study. This analysis is limited to the PWWE group. At enrollment, 260 (74.1%) were on monotherapy, 76 (21.7%) on polytherapy, and 15 (4.3%) on no AEDs. The most common AED monotherapy regimens were lamotrigine (41.9%), levetiracetam (37.7%), carbamazepine (5.4%), zonisamide (5.0%), oxcarbazepine (4.6%), and topiramate (3.1%). All other individual monotherapies were < 1%. The most common AED polytherapy combination was lamotrigine and levetiracetam (43.4%), followed by lacosamide and levetiracetam (6.6%), lamotrigine and zonisamide (5.3%); all other remaining specific combinations were < 4%. Polytherapy was dual therapy for most, with only 10.5% of polytherapy subjects on >3 AEDs (2.3% of total PWWE). For all PWWE, only three subjects (0.9%) were on valproate (1 monotherapy, 2 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 US tertiary epilepsy centers. Lamotrigine and levetiracetam are the most commonly prescribed AEDs in monotherapy or dual-polytherapy. The low rate of valproate prescriptions is likely due to 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 valproate use and are supported by reports of relatively low risks for major congenital malformations for some AED combinations. However, maternal outcomes and neurodevelopmental effects are not yet known for many AEDs and polytherapies but will be examined in the MONEAD study. Future analyses will include AED prescriptions by seizure types, frequency, and other epilepsy factors. Funding: Study supported by: NIH NINDS, NICHD #U01-NS038455.