Efficacy and side effect profile of clobazam in children with different etiologies of epilepsy from a single center

Abstract

Objectives: Clobazam is a long-acting antiepileptic drug that belongs to benzodiazepines used in the polytherapy of childhood epilepsy. In this study, our aim is to retrospectively evaluate the effectiveness and side effect profile of clobazam in children with different etiologies of epilepsy, mostly drug resistant. Methods: Forty patients aged 0-18 years that were admitted to Okmeydanı Training and Research Hospital pediatric neurology outpatient clinic between January 2017-January 2019 and prescribed clobazam were included in this study. The data of the patients who gave informed consent were extracted retrospectively from the outpatient clinic files. The patients with no seizures over 50% reduction in seizures were classified as clobazam-responsive, whereas the patients with less than 50% reductions in seizures, patients who had no response, and who manifested side effects and stopped using the drug were classified as clobazamunresponsive. Results: Twenty-three of the patients (57.5%) were male, 17 were (42.5%) were female. The average onset age of epilepsy was 31.8±37.2 months, while the average age for the prescription of clobazam was 70.6±48.9 months. The types of seizures were focal in 23 patients (57.5%) and generalized in 17 (42.5%) patients. Thirty-three (82.5%) patients had been using double or triple combinations of eight different antiepileptic drugs when clobazam was added to their treatment and accepted as drug-resistant epilepsy. The etiology of twenty one patients (52.5%) was unknown. In the remaining 19 patients (47.5%), the most common cause was structural and others were genetic, infectious and metabolic. Thirty one of the patients (77.5%) were responsive to clobazam. Of them, fifteen (37.5%) had no seizures, and 16 had a reduction in seizures (>50%). Nine (22.5%) patients were accepted as unresponsive to clobazam. The mean dose per kg was 0.7±0.3 mg/kg/day with a median of 0.63 mg/kg/day. Side effects of clobazam were encountered in 18 patients (45%); these resulted in the cessation of administration in only six (15%) patients. The side effects that cause the cessation of clobazam were sedation, refusal to take the drug due to the taste, irritability, hypersalivation, and malaise. Four patients (10%) had their doses reduced, seven patients (17.5%) responsive to clobazam although with side effects continued taking the drug as prescribed. The most common side effects of all were hyperactivity and sedation consecutively. Conclusion: Clobazam is an effective treatment for ensuring seizure freedom in pediatric epilepsy, mostly drug-resistant. The side effects are at tolerable levels in patients who are responsive to the drug.

Paediatric medicine issues and gaps from healthcare workers point of view: survey results and a narrative review from the global accelerator for paediatric formulations project

“…Clobazam tablets were reported to be too big and to have a bad taste if crushed, thus reducing children’s acceptability, in line with other studies findings. Moreover, there are frequently reported side effects including sedation, irritability, hypersalivation, and malaise, further reducing children’s compliance with the medication ( Aksu Uzunhan and Gor, 2020 ).…”