Subscribe to RSS
DOI: 10.1055/s-0043-1774744
The Clinical Efficacy and Safety of Acute Care Setting for Intravenous Levetiracetam (Focale) in Children
Funding None.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.
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/)
Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India
-
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
- 2 Gurcharran K, Grinspan ZM. The burden of pediatric status epilepticus: epidemiology, morbidity, mortality, and costs. Seizure 2019; 68: 3-8
- 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
- 4 Chin RFM. The outcomes of childhood convulsive status epilepticus. Epilepsy Behav 2019; 101 (Pt B): 106286
- 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
- 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
- 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
- 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
- 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
- 10 Hnaini M, Darwich M, Koleilat N. et al. High-dose levetiracetam for neonatal seizures: a retrospective review. Seizure 2020; 82: 7-11
- 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
- 12 Gallentine WB, Hunnicutt AS, Husain AM. Levetiracetam in children with refractory status epilepticus. Epilepsy Behav 2009; 14 (01) 215-218
- 13 Surtees TL, Kumar I, Garton HJL. et al. Levetiracetam prophylaxis for children admitted with traumatic brain injury. Pediatr Neurol 2022; 126: 114-119
- 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
- 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
- 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
- 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
- 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
- 19 Manasirisuk P, Chainirun N, Tiamkao S. et al. Efficacy of generic atorvastatin in a real-world setting. Clin Pharmacol 2021; 13: 45-51
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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
- 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