Lacosamide for neonatal seizures

Moninder Kaur, MVSc, Levon Utidjian, MD MBI, Nicholas S. Abend, MD, MSCE, Kimberley Dickinson, BS, Robert Roebling, MD, Jill McDonald, MA, Mitchell G. Maltenfort, PhD, Nadia Foskett, MD PhD, Sami Elmoufti, Rejean M. Guerriero, DO, Badal G. Jain, MD, Nathan M. Pajor, MD, Suchitra Rao, MD, Renée A. Shellhaas, MD MS, Laurel Slaughter, MD, Christopher B. Forrest, MD PhD. Retrospective Multicenter Cohort Study on Safety and Electroencephalographic Response to Lacosamide for Neonatal Seizures. Pediatric Neurology. DOI:https://doi.org/10.1016/j.pediatrneurol.2024.03.007

Highlights:

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Lacosamide was given as second- or third-line therapy in 70% of the 47 neonates.

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40% of patients were prescribed lacosamide at discharge to home from the hospital.

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19% of patients received lacosamide through the end of the 30-day follow-up period.

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No new safety signal was observed with the use of lacosamide in the neonates.

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Incidence rate of cardiac arrest per 1000 patient-days was 1.39 (95% CI 0.04-7.74).

ABSTRACT

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

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, and 94% had previously received other antiseizure medications before the index date. 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 for nervous system disorders to 10.5 (4.2, 21.6) for cardiac disorders. Electroencephalographic seizures were observed in 31/34 patients with available electroencephalographic data on the index date. There was seizure improvement in 29% of neonates on day 1 and also 29% of neonates on day 2. On day 3, there was no change in 50% of neonates and unknown change in 50% 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.