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CC BY-NC-ND 4.0 · International Journal of Epilepsy
DOI: 10.1055/s-0043-1774744
Original Article

The Clinical Efficacy and Safety of Acute Care Setting for Intravenous Levetiracetam (Focale) in Children

Siriporn Tiamkao
1   Department of Pharmacology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
2   Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, Thailand
,
Preechaya Ruangritkul
3   Department of Pharmacy Service, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand
,
Nanthaphan Chainirun
2   Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, Thailand
3   Department of Pharmacy Service, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand
,
Tarnthip Hutthawanichakornkul
3   Department of Pharmacy Service, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand
,
Issara Bungtong
3   Department of Pharmacy Service, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand
,
Pinjutha Thongjankaew
3   Department of Pharmacy Service, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand
,
Sineenard Mungmanitmongkol
2   Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, Thailand
4   Division of Nursing, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand
,
Somsak Tiamkao
2   Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, Thailand
5   Division of Neurology, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
,
Narong Auvichayapat
2   Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, Thailand
6   Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
,
Kittisak Sawanyawisuth
7   Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
,
on Behalf of Integrated Epilepsy Research Group, Khon Kaen University › Author Affiliations Funding None.
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Abstract

Background Status epilepticus (SE) is a serious neurological emergency with a high mortality rate. Although levetiracetam is an effective antiepileptic drug for managing SE, its excessive cost may limit its accessibility. Focale, a more affordable generic version, is currently available and is more than 50% less expensive than the original version. However, there is currently no study on the efficacy and safety of Focale in pediatric patients with SE.

Objective This study aimed to investigate the efficacy and safety of the antiepileptic drug, Focale, in pediatric patients.

Materials and Methods This was a retrospective study that examined 131 pediatric patients younger than 18 years, who were treated with Focale for seizure control and prevention between June 2019 and November 2022.

Results A total of 131 patients were included in the study, of which 73 (55.7%) were male. The age group with the highest frequency was 0 to 3 years old (28.2%). Focale was used with the following indications: (1) SE (45.04%), (2) acute repetitive convulsive seizures (22.14%), (3) primary prophylaxis (26.72%), (4) acute first seizure (1.52%), and (5) patients with epilepsy with nothing per oral (4.58%). Regarding the outcomes, the seizure-controlled rate in the seizure group was 81.1%, while the seizure prevention rate was 92.7% for those who received Focale as a seizure prophylaxis. Only 2 out of 131 patients had experienced adverse effects (1.5%).

Conclusion The generic intravenous levetiracetam treatment had high seizure-controlled rate in patients with seizure attacks and seizure prevention rate in the seizure prophylaxis group in pediatric patients. Side effects of this regimen in pediatric patients were low.

Keywords

Focale - levetiracetam - children - efficacy - safety


Publication History

Article published online:
10 October 2023

© 2023. Indian Epilepsy Society. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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  • References

  • 1 Trinka E, Cock H, Hesdorffer D. et al. A definition and classification of status epilepticus – report of the ILAE Task Force on Classification of Status Epilepticus. Epilepsia 2015; 56 (10) 1515-1523
    CrossrefPubMedGoogle Scholar
  • 2 Gurcharran K, Grinspan ZM. The burden of pediatric status epilepticus: epidemiology, morbidity, mortality, and costs. Seizure 2019; 68: 3-8
    CrossrefPubMedGoogle Scholar
  • 3 McTague A, Martland T, Appleton R. Drug management for acute tonic-clonic convulsions including convulsive status epilepticus in children. Cochrane Database Syst Rev 2018; 1 (01) CD001905
    PubMedGoogle Scholar
  • 4 Chin RFM. The outcomes of childhood convulsive status epilepticus. Epilepsy Behav 2019; 101 (Pt B): 106286
    CrossrefPubMedGoogle Scholar
  • 5 Glauser T, Shinnar S, Gloss D. et al. Evidence-based guideline: treatment of convulsive status epilepticus in children and adults: report of the Guideline Committee of the American Epilepsy Society. Epilepsy Curr 2016; 16 (01) 48-61
    CrossrefPubMedGoogle Scholar
  • 6 Klowak JA, Hewitt M, Catenacci V. et al. Levetiracetam versus phenytoin or fosphenytoin for second-line treatment of pediatric status epilepticus: a meta-analysis. Pediatr Crit Care Med 2021; 22 (09) e480-e491
    CrossrefPubMedGoogle Scholar
  • 7 Chamberlain JM, Kapur J, Shinnar S. et al; Neurological Emergencies Treatment Trials, Pediatric Emergency Care Applied Research Network Investigators. Efficacy of levetiracetam, fosphenytoin, and valproate for established status epilepticus by age group (ESETT): a double-blind, responsive-adaptive, randomised controlled trial. Lancet 2020; 395 (10231): 1217-1224
    CrossrefPubMedGoogle Scholar
  • 8 Hooper RG, Ramaswamy VV, Wahid RM, Satodia P, Bhulani A. Levetiracetam as the first-line treatment for neonatal seizures: a systematic review and meta-analysis. Dev Med Child Neurol 2021; 63 (11) 1283-1293
    CrossrefPubMedGoogle Scholar
  • 9 Wongjirattikarn R, Sawanyawisuth K, Pranboon S, Tiamkao S, Tiamkao S. Can generic intravenous levetiracetam be used for acute repetitive convulsive seizure or status epilepticus? A randomized controlled trial. Neurol Ther 2019; 8 (02) 425-431
    CrossrefPubMedGoogle Scholar
  • 10 Hnaini M, Darwich M, Koleilat N. et al. High-dose levetiracetam for neonatal seizures: a retrospective review. Seizure 2020; 82: 7-11
    CrossrefPubMedGoogle Scholar
  • 11 İşgüder R, Güzel O, Ağın H. et al. Efficacy and safety of IV levetiracetam in children with acute repetitive seizures. Pediatr Neurol 2014; 51 (05) 688-695
    CrossrefPubMedGoogle Scholar
  • 12 Gallentine WB, Hunnicutt AS, Husain AM. Levetiracetam in children with refractory status epilepticus. Epilepsy Behav 2009; 14 (01) 215-218
    CrossrefPubMedGoogle Scholar
  • 13 Surtees TL, Kumar I, Garton HJL. et al. Levetiracetam prophylaxis for children admitted with traumatic brain injury. Pediatr Neurol 2022; 126: 114-119
    CrossrefPubMedGoogle Scholar
  • 14 Kolf MJ, McPherson CC, Kniska KS, Luecke CM, Lahart MA, Pineda JA. Early post-traumatic seizure occurrence in pediatric patients receiving levetiracetam prophylaxis with severe traumatic brain injury. J Pediatr Pharmacol Ther 2020; 25 (03) 241-245
    PubMedGoogle Scholar
  • 15 Kreimer AM, Littrell RA, Gibson JB, Leung NR. Effectiveness of levetiracetam as a first-line anticonvulsant for neonatal seizures. J Pediatr Pharmacol Ther 2019; 24 (04) 320-326
    PubMedGoogle Scholar
  • 16 Rao LM, Hussain SA, Zaki T. et al. A comparison of levetiracetam and phenobarbital for the treatment of neonatal seizures associated with hypoxic-ischemic encephalopathy. Epilepsy Behav 2018; 88: 212-217
    CrossrefPubMedGoogle Scholar
  • 17 Han JY, Moon CJ, Youn YA, Sung IK, Lee IG. Efficacy of levetiracetam for neonatal seizures in preterm infants. BMC Pediatr 2018; 18 (01) 131
    CrossrefPubMedGoogle Scholar
  • 18 Fang T, Valdes E, Frontera JA. Levetiracetam for seizure prophylaxis in neurocritical care: a systematic review and meta-analysis. Neurocrit Care 2022; 36 (01) 248-258
    CrossrefPubMedGoogle Scholar
  • 19 Manasirisuk P, Chainirun N, Tiamkao S. et al. Efficacy of generic atorvastatin in a real-world setting. Clin Pharmacol 2021; 13: 45-51
    PubMedGoogle Scholar
  • 20 Khamsai S, Kachenchart S, Sawunyavisuth B. et al. Prevalence and risk factors of obstructive sleep apnea in hypertensive emergency. J Emerg Trauma Shock 2021; 14 (02) 104-107
    CrossrefPubMedGoogle Scholar
  • 21 Jeerasuwannakul B, Sawunyavisuth B, Khamsai S, Sawanyawisuth K. Prevalence and risk factors of proteinuria in patients with type 2 diabetes mellitus. Asia Pac J Sci Technol 2021; 26 (04) 26
    PubMedGoogle Scholar
  • 22 Charoentanyarak S, Sawunyavisuth B, Deepai S, Sawanyawisuth K. A point-of-care serum lactate level and mortality in adult sepsis patients: a community hospital setting. J Prim Care Community Health 2021; 12: 21 501327211000233
    CrossrefPubMedGoogle Scholar
  • 23 Tongdee S, Sawunyavisuth B, Sukeepaisarnjaroen W, Boonsawat W, Khamsai S, Sawanyawisuth K. Clinical factors predictive of appropriate treatment in COPD: a community hospital setting. Drug Target Insights 2021; 15: 21-25
    CrossrefPubMedGoogle Scholar
  • 24 Namwaing P, Ngamjarus C, Sakaew W. et al. Chest physical therapy and outcomes in primary spontaneous pneumothorax: a systematic review. J Med Assoc Thai 2021; 104: S165-S168
    CrossrefPubMedGoogle Scholar
  • 25 Khamsai S, Mahawarakorn P, Limpawattana P. et al. Prevalence and factors correlated with hypertension secondary from obstructive sleep apnea. Multidiscip Respir Med 2021; 16 (01) 777
    PubMedGoogle Scholar
  • 26 Sanlung T, Sawanyawisuth K, Silaruks S. et al. Clinical characteristics and complications of obstructive sleep apnea in Srinagarind Hospital. J Med Assoc Thai 2020; 103 (01) 36-39
    PubMedGoogle Scholar
  • 27 Kaewkes C, Sawanyawisuth K, Sawunyavisuth B. Are symptoms of obstructive sleep apnoea related to good continuous positive airway pressure compliance?. ERJ Open Res 2020; 6 (03) 00169-02019
    CrossrefPubMedGoogle Scholar
  • 28 Boonwang T, Namwaing P, Srisaphonphusitti L. et al. Esports may improve cognitive skills in soccer players: a systematic review. Asia Pac J Sci Technol 2022; 27 (03) DOI: 10.14456/apst.2022.44.
    CrossrefPubMedGoogle Scholar
  • 29 Sawunyavisuth B, Ngamjarus C, Sawanyawisuth K. Any effective intervention to improve CPAP adherence in children with obstructive sleep apnea: A systematic review. Glob Pediatr Health 2021 ;8:2333794X211019884
    PubMedGoogle Scholar
  • 30 Sawunyavisuth B, Ngamjarus C, Sawanyawisuth K. Adherence to continuous positive airway pressure therapy in pediatric patients with obstructive sleep apnea: a meta-analysis. Ther Clin Risk Manag 2023; 19: 143-162
    CrossrefPubMedGoogle Scholar