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Indian Pediatr 2020;57: 80-81 |
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Levetiracetam is Still Not a First-line Treatment in Neonatal
Seizures: Author's Reply
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Vykuntaraju K Gowda
Division of Pediatric Neurology, Department of Pediatrics, Indira
Gandhi Institute of Child Health, Bengaluru,
Karnataka, India.
Email: [email protected]
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We thank the reader for critically evaluating our
research study [1]. The queries raised are addressed below:
Video EEG was not done in our study and we have
already mentioned it as a study limitation, and the same has also been
highlighted in the accompanying editorial [1,2]. We agree that most
neonatal seizures are symptomatic and do not require long-term
medications. Our objective was to find out short-term outcome, and it
was expected that randomization would have overcome any bias due to
spontaneous seizure resolution or resolution due to medications, as it
applies for both groups.
Following first dose of levetiracetam (LEV), seizures
stopped in 30 (60%) neonates and following second dose, seizures stopped
in 43 (86%) in our study [1]. The dose of LEV is not established in
neonates and, we used a dose based on published studies, evidence
available from off-label use, and our experience. The phase 2b
randomized controlled study (NEOLEV2) was published after our study was
completed [3]. As there are studies showing that both phenobarbitone
(PB) and LEV are equally effective but LEV has lesser side-effects, we
need more studies to find a definite answer in this regard.
Our study is on neonatal seizures in general and not
specific to hypoxic ischemic encephalopathy (HIE), that may be the
reason for mean age being 8-9 days. None of our newborns received
therapeutic hypothermia. We have proposed levetiracetam as an effective
and safer alternative to phenobarbitone as a first line drug in neonatal
seizures, and not in neonates with HIE [1]. We agree about the need for
long term studies to look for neurodevelopmental outcome of these
neonates, and the same has been acknowledged already as a limitation of
our study.
References
1. Gowda VK, Romana A, Shivanna NH, Benakappa N,
Benakappa A. Levetiracetam versus phenobarbitone in neonatal seizures –
A randomized controlled trial. Indian Pediatr. 2019;56:643-6.
2. Swami M, Kaushik JS. Levetiracetam in neonatal
seizures. Indian Pediatr.2019; 56:639-40.
3. Sharpe C, Reiner GE, Davis SL, Nespeca M, Gold JJ,
Rasmussen M, et al. A randomized controlled trial of
levetiracetam compared with phenobarbital in the treatment of neonatal
seizures. (June 17, 2019). Available at:
https://ssrn.com/abstract=3405581. Accessed on October 11, 2019.
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