Retrospective Multicenter Cohort Study on Safety and Electroencephalographic Response to Lacosamide for Neonatal Seizures - 18/05/24
, Levon Utidjian, MD, MBI c, Nicholas S. Abend, MD, MSCE d, Kimberley Dickinson, BS c, Robert Roebling, MD e, Jill McDonald, MA c, Mitchell G. Maltenfort, PhD c, Nadia Foskett, MD, PhD a, Sami Elmoufti, MSc f, Rejean M. Guerriero, DO g, Badal G. Jain, MD h, Nathan M. Pajor, MD i, Suchitra Rao, MD j, Renée A. Shellhaas, MD, MS g, Laurel Slaughter, MD k, Christopher B. Forrest, MD, PhD cAbstract |
Background |
There is growing evidence supporting the safety and effectiveness of lacosamide in older children. However, minimal data are available for neonates. We aimed to determine the incidence of adverse events associated with lacosamide use and explore the electroencephalographic seizure response to lacosamide in neonates.
Methods |
A retrospective cohort study was conducted using data from seven pediatric hospitals from January 2009 to February 2020. For safety outcomes, neonates were followed for ≤30 days from index date. Electroencephalographic response of lacosamide was evaluated based on electroencephalographic reports for ≤3 days.
Results |
Among 47 neonates, 98% received the first lacosamide dose in the intensive care units. During the median follow-up of 12 days, 19% of neonates died, and the crude incidence rate per 1000 patient-days (95% confidence interval) of the adverse events by diagnostic categories ranged from 2.8 (0.3, 10.2) for blood or lymphatic system disorders and nervous system disorders to 10.5 (4.2, 21.6) for cardiac disorders. Electroencephalographic seizures were observed in 31 of 34 patients with available electroencephalographic data on the index date. There was seizure improvement in 29% of neonates on day 1 and also in 29% of neonates on day 2. On day 3, there was no change in 50% of neonates and unknown change in 50% of neonates.
Conclusions |
The results are reassuring regarding the safety of lacosamide in neonates. Although some neonates had fewer seizures after lacosamide administration, the lack of a comparator arm and reliance on qualitative statements in electroencephalographic reports limit the preliminary efficacy results.
Le texte complet de cet article est disponible en PDF.Keywords : Neonate, Lacosamide, Electroencephalographic (EEG) response, Safety
Plan
| Funding: This study was sponsored by UCB Pharma. The sponsor was involved in study design, interpretation of data, in the writing of the report, and in the decision to submit the article for publication, and PEDSnet was involved in the data collection and data analysis and in the decision to submit the article for publication. |
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| Ethics approval and patient consent statement: The PEDSnet database is operated under waivers of consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, granted, respectively, by Institutional Review Boards and Privacy Offices at member institutions. Original analytical study datasets were not shared with UCB Pharma. |
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| Data statement: As per PEDSnet data sharing policy, the data will not be shared with any third party including UCB Pharma. |
Vol 155
P. 18-25 - juin 2024 Retour au numéro
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