Przebieg ciąż u kobiet z epilepsją leczonych eslicarbazepem: analiza globalnej bazy bezpieczeństwa od badań klinicznych do 16 lat obserwacji po wprowadzeniu leku
Pregnancy outcomes following Eslicarbazepine acetate exposure in women with epilepsy: A global safety database analysis from clinical development to 16 years of post-marketing experience
W skrócie
Naukowcy przeanalizowali dane o 159 ciążach u kobiet z epilepsją, które były narażone na lek zwany eslicarbazepem. Wyniki pokazują, że u większości ciąż (56%) rodziły się zdrowe dzieci, choć u części kobiet (30%) doszło do powikłań takich jak poroniania czy wady wrodzone. Badacze stwierdzili, że eslicarbazepina wydaje się bezpieczna w ciąży, ale wciąż potrzeba więcej badań obserwacyjnych, aby dać kobietom z epilepsją pełne informacje przed planowaniem rodziny.
Oryginalny abstract (angielski)
PURPOSE: Continuous collection of comprehensive data on women with epilepsy and their antiseizure medication use is essential, since current knowledge of associated risks remains limited. Our previous analysis (Costa et al. 2018) indicated that available data on the use of eslicarbazepine acetate (ESL) were insufficient to support definitive conclusions in pregnant women. To address this limitation, we have continued to systematically collect and evaluate pregnancy exposure and outcomes, with the objective of refining the understanding of ESL safety during pregnancy as additional evidence has accrued. METHODS: Pregnancy cases involving exposure to eslicarbazepine acetate were identified through a review of ESL exposure from the global safety database (including post-marketing and clinical trials cases), cumulatively up to September 30th, 2025, supplemented by searches of the EMBASE™ and MEDLINE® databases for relevant literature published between May 1st, 2009 (launch date) and September 30th, 2025. RESULTS: Overall, 159 notifications of pregnancy with ESL exposure were included in this analysis, 91 with known outcomes: 51 normal live births (56%, 51/91), 13 termination of pregnancies (14%, 13/91) and 27 with adverse outcomes (30%, 27/91); these including 13 miscarriages, 8 cases of congenital anomalies, 4 cases of neonate adverse effects and two premature birth. In 16 of these 27 pregnancies with adverse outcomes, ESL was used as add-on therapy to other ASMs, rather than as monotherapy. The literature review did not identify additional relevant information. CONCLUSIONS: Across all years with ESL exposure, no consistent pattern of congenital disorders or miscarriages was observed in pregnant women with epilepsy. While large safety databases support signal detection, there remains a need for high‑quality, adequately powered observational studies and continued pharmacovigilance to guide informed clinical decision‑making in this vulnerable population.