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Safety and Efficacy of Levetiracetam and Carbamazepine Monotherapy in the Management of Pediatric Focal Epilepsy: A Randomized Clinical Trial Publisher



Montazerlotfelahi H1 ; Haj Mohamad Ebrahim Ketabforoush A2 ; Tavakol M3 ; Ashrafi M4 ; Dehghani M5 ; Mostafavi K6 ; Mardi S7 ; Tajfirooz S8
Authors
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Authors Affiliations
  1. 1. Department of Pediatric Neurology, Faculty of Medicine, Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, Iran
  2. 2. Student Research Committee, Alborz University of Medical Sciences, Karaj, Iran
  3. 3. Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran
  4. 4. Department of Pediatric Neurology, Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Department of Oral and Maxillofacial, Faculty of Dentistry, Tehran Medical Sciences of Islamic Azad University, Tehran, Iran
  6. 6. Department of the Pediatrics, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran
  7. 7. Student Research Committee, Arak University of Medical Sciences, Arak, Iran
  8. 8. Department of the Pediatrics, Faculty of Medicine, Imam Ali Hospital, Alborz University of Medical Sciences, Vali-Asr St., Shora Ave, Karaj, Iran

Source: Naunyn-Schmiedeberg's Archives of Pharmacology Published:2024


Abstract

Due to the limited number of studies in children with focal epilepsy and the importance of choosing the most suitable drug to control seizures in children, the administration of the most effective medication with the most negligible adverse events is vital. This study aimed to evaluate the effectiveness and adverse events of carbamazepine vs. levetiracetam monotherapy in children with focal seizures. A monocentric, randomized, controlled, double-blind, parallel-group clinical trial was designed. This study was approved by the Iranian Registry of Clinical Trials (registration number: IRCT20170216032603N2) on June 19, 2020, and conducted at the neurology department of Imam Ali Hospital, Karaj, Iran, from February 2020 to March 2021. This study assessed 120 patients with recently diagnosed focal seizures aged 2 to 14. Patients were randomly divided into two groups, who received carbamazepine (CBZ) 15 to 20 mg/kg and levetiracetam (LEV) 20 to 40 mg/kg daily, respectively. Patients were evaluated for improvement and complications at weeks 4, 12, and 24. Out of 120 patients included in the study, six patients were excluded due to various complications of CBZ. The mean number of seizures at the end of the fourth, twelfth, and twenty-fourth weeks were 1.09 ± 0.75, 0.62 ± 0.27, and 0.39 ± 0.12 in the carbamazepine group and 1.11 ± 0.63, 0.52 ± 0.21, and 0.37 ± 0.11 in the LEV group, respectively (P > 0.05). Similarly, the number of seizure-free patients was 34, 44, and 48 in the CBZ group compared to 41, 50, and 54 in the LEV group, respectively (P > 0.05). On the other hand, the frequency of somnolence, dermatologic complications, and agitation was considerably higher in the CBZ group (P < 0.05). Although both medicines were equally effective in seizure control, CBZ was associated with considerably more adverse events and less patient compliance. Physicians should be aware of this difference to prevent unwanted consequences. © 2024, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.