Efficacy and Safety of Lacosamide in Infants
Abstract number :
3.414
Submission category :
7. Anti-seizure Medications / 7C. Cohort Studies
Year :
2021
Submission ID :
1886424
Source :
www.aesnet.org
Presentation date :
12/6/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:56 AM
Authors :
Abdullah Shoaib, MD - University of Texas Southwestern Medical Center; Alison Dolce, MD - Assistant Professor, Pediatric Neurology, University of Texas Southwestern Medical Center; Michelle Machie, MD - Assistant Professor, Child Neurology, University of Texas Southwestern Medical Center; Jennifer Thomas, MD - Assistant Professor, Child Neurology, UT Southwestern Medical Center
Rationale: Lacosamide is an antiepileptic medication that was approved by the Food and Drug Administration in 2008. Due to its efficacy, lack of drug interactions, and favorable side effect profile, it has been used extensively in adult populations. Research has demonstrated its efficacy and tolerability in children as well. However, these studies almost exclusively investigated patients that were 4 years of age and older. As such, there is a paucity of research in the neonatal and infant age groups [1]. This study aims to address this gap in the current literature by reviewing charts of infants started on lacosamide to investigate the efficacy and safety in this age group.
[1] Miskin C, Khurana DS, Valencia I, Legido A, Hasbani DM, Carvalho KS. Efficacy and tolerability of lacosamide in the treatment of children with refractory generalized epilepsy. J Child Neurol. 2016;31(7):925-928.
Methods: With the assistance of health informatics, the team was able to extract the charts of patients who were less than 24 months of age when they first received lacosamide. A total of 101 unique patient charts from Parkland Memorial Hospital and Children’s Medical Center in Dallas, TX, were included in this study.
Patients’ charts were reviewed and data was extracted manually, including age of onset of seizures, age at which lacosamide was first given, loading dose, medications used prior to lacosamide, as well as starting and maximum dose of lacosamide. Patient charts were reviewed until patients reached 24 months of age to see if any adverse effects appeared while on long-term lacosamide, and if symptoms improved after cessation of lacosamide. Efficacy was assessed by determining approximate percentage reduction in seizure burden after initiation of lacosamide (non-responders, reduction < 50%, reduction > 50%).
Results: Of the 101 patients included in the study, 62 (61.4%) of patients studied had a greater than 50% reduction in seizure burden with initiation of lacosamide, 33 (32.7%) had a less than 50% reduction in seizure burden, and 5 (5.0%) had no improvement in seizure burden.
5 patients had documented side effects: 2 had mild behavior changes, 1 had worsened seizures, and 2 had abnormal movements (1 patient had abnormal eye movements, another abnormal arm movements). The patient with worsened seizures was later diagnosed with a sodium channelopathy. The patients with abnormal eye and arm movements were transitioned off of lacosamide, but despite observation for 1 and 3 months respectively, these abnormal movements have not improved.
Conclusions: Lacosamide was efficacious in our infant population, with 61% achieving greater than 50% reduction in seizure burden. In addition, lacosamide was well-tolerated with no hepatic, renal, or cardiac side effects seen in any of the patients in this study. Cardiac and hematologic side effects, though reported in the literature, were not seen in our sample.
This study is among the first and largest retrospective chart reviews investigating lacosamide in infants less than 2 years old and suggests that lacosamide is both efficacious and well-tolerated in this age group.
Funding: Please list any funding that was received in support of this abstract.: No funding received.
Anti-seizure Medications