Efficacy of Levetiracetam and Phenobarbital as First-Line Treatment for Neonatal Seizures

Verwoerd, Carmen; Limjoco, Jamie; Rajamanickam, Victoria; Knox, Andrew T.

doi:10.1177/08830738221086107

Cited by 12 publications

(10 citation statements)

References 37 publications

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“…A 13 (76%) patients treated with LEV had a sustained seizure burden of 20% compared with 6 (75%) treated with PB. 25 Neonates who received PB showed more reduction in the seizure burden in the hours pre-and post-treatment (24.3 vs 14.2 minutes/hour). However, 6 of 17 (35%) neonates who received LEV remained seizure free after initial treatment, compared with 2 of 8 (25%) neonates who received PB.…”

Section: Discussionmentioning

confidence: 88%

“…A 13 (76%) patients treated with LEV had a sustained seizure burden of 20% compared with 6 (75%) treated with PB. 25 …”

Section: Discussionmentioning

confidence: 99%

“…Although these results were statistically non-significant, LEV remains a promising first-line agent for neonatal seizures. 25 …”

Section: Discussionmentioning

confidence: 99%

“…Although these results were statistically nonsignificant, LEV remains a promising first-line agent for neonatal seizures. 25 NEOLEV2 is the first RCT comparing the efficacy, dose-escalation, and adverse effects of LEV to PB as first line treatment in neonatal seizures detected by EEG. PB was found to be a better anticonvulsant in controlling electrographic seizures after analyzing clinical and electrographic cessations of seizures.…”

Section: Discussionmentioning

confidence: 99%

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A Comparative Study of Levetiracetam and Phenobarbital for Neonatal Seizures as a First Line Treatment

Akeel

Suliman

Al-Shokary

et al. 2022

Global Pediatric Health

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Objectives We aimed to evaluate the use of intravenous levetiracetam as the first-line treatment of neonatal seizures compared with phenobarbital. Methods The study was conducted on 104 neonates (0-28 days) with clinical seizures after inclusion criteria. They were assigned in equal ratio into 2 groups; 1 included neonates who received phenobarbitone, and the other included neonates who received levetiracetam. Neonates were loaded with 20 mg/kg of intravenous drug-A (phenobarbitone) or drug-B (levetiracetam). In persistent seizures, a second loading dose of the same drug was given. Crossover to other drugs occurred if seizures persisted after the second dose of the same drug. The proportion of neonates who achieved cessation of seizures following the first or second loading dose of either drug-A or drug-B (PB or LEV) was the main outcome measure provided that they remained free of seizure for the following 24 hours. Results After 1 or 2 doses of Levetiracatam or Phenobarbitone, clinical seizures stopped (and remained seizure-free for 24 hours) in 41 (78.84%) and 34 (65.38%) patients, respectively ( P = .01). Neonates in the LEV group showed better seizure control than neonates in the PB group (RR = 0.57; 95% CI (0.17, 0.80). We did not report any adverse drug reactions in the LEV group. However, 12 (23.07%) neonates developed adverse drug reactions in the PB Group. Conclusion Levetiracetam is considered an effective and safe drug as a first-line AED in neonatal seizures.

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Section: Discussionmentioning

confidence: 88%

“…A 13 (76%) patients treated with LEV had a sustained seizure burden of 20% compared with 6 (75%) treated with PB. 25 …”

Section: Discussionmentioning

confidence: 99%

“…Although these results were statistically non-significant, LEV remains a promising first-line agent for neonatal seizures. 25 …”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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A Comparative Study of Levetiracetam and Phenobarbital for Neonatal Seizures as a First Line Treatment

Akeel

Suliman

Al-Shokary

et al. 2022

Global Pediatric Health

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“…In addition, the study found that only 26% of premature infants less than 28 weeks could be controlled by LEV (80 mg/kg/day), suggesting that small gestational age is a risk factor for LEV treatment failure 3 . A retrospective study showed that LEV at an initial dose of 50–100 mg/Kg was as effective as PB in controlling neonatal epilepsy (gestational age ≥ 35 weeks) 4 . Liu BK et al found that there was no significant difference in the short‐term efficacy (3 days) between the phenobarbital and levetiracetam group (8–54 mg/kg/d) in the treatment of neonatal epilepsy (gestational age: 38 [38,40] weeks) 5 .…”

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confidence: 99%

EBNEO Commentary: Need to further study levetiracetam as first‐line drug for neonatal convulsions

Ning

2022

Acta Paediatrica

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This prospective multicentre randomised controlled trial compared the efficacy and safety of levetiracetam (40 mg/Kg) with phenobarbital as the first-line treatment for neonatal epilepsy, which showed that phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. 1 This study differs from others in that it is one of the first prospective studies using cEEG in neonates, and the use of cEEG to confirm the presence of electrographic epilepsy is a strength of this study. Because not all electrographic seizures can be accurately identified by clinicians only by visual assessment. However, Methodological biases may render a clinical study underpowered. While it is true that 280 patients were enrolled, only 30 patients were analysed in the Phenobarbital arm and 53 patients were analysed in the LEV arm, which is a small phase IIb study rather than a large phase III randomised control trial. When power calculations are calculated on a predicted response and the measured response is considerably different, it is difficult to interpret the study's validity. This has probably been one of the more controversial aspects of this publication, being that the efficacy of the phenobarbital was so high in this small population.Compared with older children and adults, the pharmacokinetics of levetiracetam in neonates has a wider volume of distribution and faster clearance, and tends to be administered in higher doses, 2 but the appropriate dose has not been determined. In addition, the study found that only 26% of premature infants less than 28 weeks could be controlled by LEV (80 mg/kg/day), suggesting that small gestational age is a risk factor for LEV treatment failure. 3 A retrospective study showed that LEV at an initial dose of 50-100 mg/Kg was as effective as PB in controlling neonatal epilepsy (gestational age ≥ 35 weeks). 4 Liu BK et al. found that there was no significant difference in the short-term efficacy (3 days) between the phenobarbital and levetiracetam group (8-54 mg/kg/d) in the treatment of neonatal epilepsy (gestational age: 38 [38,40] weeks). 5 The gestational age of newborns in the study by Sharpe et al. was 36 to 44 weeks, and LEV (40 mg/Kg) was less effective than PB. 1 Neonatal gestational age and dosing range of levetiracetam were inconsistent across the three studies, so definite conclusions were ultimately unable to make.Based on the above studies, it is highly controversial whether LEV or PB should be used as a first-line drug to treat neonatal seizures. However, because levetiracetam has a neuroprotective effect with fewer adverse reactions, [6][7] it is of great significance to further study whether LEV is stronger than phenobarbital and whether it can be used as a first-line drug for the treatment of neonatal seizures. I am eagerly looking forward to determining the optimal dose and dosing schedule of levetiracetam with uniform observational metrics and criteria, which need to include the effect of gestational age on the drug.

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Anti-seizure medications for neonates with seizures

Abiramalatha,

Thanigainathan,

Ramaswamy

et al. 2023

Cochrane Database of Systematic Reviews

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This is a protocol for a Cochrane Review (intervention). The objectives are as follows:1. To assess whether any anti-seizure medication (ASM) is more or less e ective than an alternative ASM (both ASMs used as first-, secondor third-line treatment) in achieving seizure control and improving neurodevelopmental outcomes in neonates with seizures. We will analyse EEG-confirmed seizures and clinically-diagnosed seizures separately. 2. To assess maintenance therapy with ASM compared to no maintenance therapy a er achieving seizure control. We will analyse EEGconfirmed seizures and clinically-diagnosed seizures separately. 3. To assess any ASM treatment compared to no ASM treatment for clinically-diagnosed or only-electrographic seizures.

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Efficacy of Levetiracetam and Phenobarbital as First-Line Treatment for Neonatal Seizures

Cited by 12 publications

References 37 publications

A Comparative Study of Levetiracetam and Phenobarbital for Neonatal Seizures as a First Line Treatment

A Comparative Study of Levetiracetam and Phenobarbital for Neonatal Seizures as a First Line Treatment

EBNEO Commentary: Need to further study levetiracetam as first‐line drug for neonatal convulsions

Anti-seizure medications for neonates with seizures

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