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All Journal HAYATI Journal of Biosciences EKSAKTA: Journal of Sciences and Data Analysis Indonesian Journal of Cancer INDONESIAN JOURNAL OF PHARMACY JURNAL FARMASI DAN ILMU KEFARMASIAN INDONESIA The Indonesian Biomedical Journal Paediatrica Indonesiana Journal of Medicine and Health Molecular and Cellular Biomedical Sciences (MCBS) Syntax Literate: Jurnal Ilmiah Indonesia Farmasains : Jurnal Ilmiah Ilmu Kefarmasian Majalah Farmasi dan Farmakologi (Trends in Pharmacy and Pharmaceutical Sciences) JFL : Jurnal Farmasi Lampung Eksakta : Berkala Ilmiah Bidang MIPA Jurnal Ilmu Kefarmasian Indonesia Majalah Kedokteran Andalas Jurnal Jamu Indonesia Majalah Patologi Indonesia Jurnal Ekonomi Muhammadiyah Journal of Geriatric Indonesian Journal of Cancer Pharmaceutical Sciences and Research (PSR) Indonesian Journal of Medical Chemistry and Bioinformatics Jurnal Kefarmasian Indonesia Indonesian Journal of Jamu Journal of Medicine and Health
Wawaimuli Arozal
Universitas Indonesia
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Journal : Paediatrica Indonesiana

 1 
Therapeutic reassessment of first-line antiepileptic drugs in pediatric patients unresponsive to second-line agents: a randomized trial in Jakarta Perdani, Roro Rukmi Windi; Arozal, Wawaimuli; Mangunatmadja, Irawan; Kaswandani, Nastiti; Handryastuti, Setyo; Medise, Bernie Endyarni; Wardani, Amanda Saphira; Thandavarayan, Rajarajan Amirthalingam; Oswari, Hanifah; Lee, Hee Jae
Paediatrica Indonesiana Vol. 65 No. 6 (2025): November 2025
Publisher : Indonesian Pediatric Society

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Abstract

Background Epilepsy has a significant incidence in children, with 20-25% resistance to standard antiepileptic drugs (AEDs). Drug-resistant epilepsy (DRE) refers as the failure of two or more AEDs, either as monotherapies or in combination, to achieve seizure freedom, which includes the absence of all seizure types, even auras. Treatment algorithms for children with epilepsy range from starting with the lowest effective dose to using add-on or substitution therapy of AEDs. It usually started from using first-line AEDs (valproic acid, phenytoin, phenobarbital, carbamazepine) with titrated dose based on the patient condition, if seizure persist, another first-line AEDs may be added or substituted. Second-line AEDs (topiramate, levetiracetam, oxcarbazepine) are introduced when seizure persist despite optimal doses of first-line drugs with good compliance. Epilepsy treatment response is a dynamic process, not a fixed state. In some cases, repeating the medication cycle remains an option, as patient may initially appear drug-resistant but later respond to treatment. Thus, first-line AEDs may also serve as substitution therapy in children unresponsive to second-line agents as studies show comparable effectiveness between the two regimens. Objective To evaluate the efficacy and safety of first-line AEDs as substitution therapy (intentional replacement of patient’s current medication) in children resistant to second-line AEDs. Methods This 12-week, open-label, multicenter, randomized controlled trial was conducted in 91 epileptic children. Children aged 1 – 18 years with DRE, were randomized into the intervention (patients who received substitution therapy:  one AEDs was changed to first-line of AEDs) and control (patients who got standard therapy: one AEDs was changed to second-line of AEDs) groups. The primary outcome was the difference in the proportion of responders between the two groups. Secondary outcomes were analyzing the different improvements in quality of life (QoL), EEG feature, and time to achieve seizure reduction in both groups. The QoL was assessed by Quality of Life in Childhood Epilepsy Questionnaire 55 (QOLCE-55) to assess cognitive, emotional, social, and physical functions. Results There were no significant differences in the proportion of responders between the substitution therapy group (62.5%) and the standard therapy group (68.4%). Both groups experienced substantial reductions in seizure frequency, ranging from 78% to 80%. For further analysis, the average difference of seizure frequency before and after intervention was statistically significant in each group, it was P=0.000 in substitution group and P=0.00 in standard group. The analysis of quality of life showed the mean of total score in both groups was low even though the score was higher in the substitution group. For spesific function of quality of life, the cognitive and social function, was improved significantly in the group p<0.05). However, there were no significant differences of EEG improvement, seizure duration, time to achieve seizure frequency reduction, or adverse effects between the two groups. Conclusions First-line AEDs have comparable efficacy as second-line AEDs with mild to moderate adverse effects in DRE children. Thus, the repeated use of first-line AEDs as substitution therapy might be an option for children who resistant to second line AEDS.
Co-Authors Agatha Grace Agian Jeffilano Barinda Andrea Laurentius Arleni Bustami Aryo Tedjo Barinda, Again Jeffilano Bernie Endyarni Medise Cong, Tzeto Han Deni Rahmat Dewi Sukmawati Dewi, Yulia Ratna Djumhana Atmakusuma Djumhana Atmakusuma, Djumhana Dwita, Nounik Cheri Edhiatmi, Marsetyo Erlina, Linda Erni H Purwaningsih Erni H Purwaningsih, Erni H Erni Hernawati Purwaningsih, Erni Hernawati Ernie Purwaningsih Eviarini, Prawitasari Eziefule, Oluebube Magnificient Fadhillah, Muhamad Rizqy Fadilah Fadilah Fadilah, Fadilah Fajarido, Ariski Fatriansyah, Jaka Fajar Femmi Dwinda Agustini Franciscus D. Suyatna Gregorius Bhaskara Wikanendra Gusti Khatimah, Nurul Hanifah Oswari Hedi R. Dewoto Heri Wibowo Hesty Utami Husna, Fauzul Indah D Dewijanti Indah D Dewijanti, Indah D Irawan Mangunatmadja Jusman, Sri Widia Azraki Kapuangan, Christopher Kartika, Kartika Handayani Kenichi Watanabe Khatimah, Nurul Gusti Kuncoro, Daviet Dwi Kurniasari Kurniasari Kusmardi Kusmardi Kusmardi Kusmardi Laurentius, Andrea Lee, Hee Jae Marliana Sri Rejeki Marliana Sri Rejeki Marliana Sri Rejeki Marselina Marselina Marsetyo Edhiatmi Meilei Ma Melva Louisa Monayo, Edwina Rugayah Muhamad Sadam Safutra Musridharta, Eka Nabillah, Deya Adiby Nafrialdi Nafrialdi Nastiti Kaswandani Ni Made Dwi Sandhiutami Novi Silvia Hardiany Nur Azizah Nurwulan Adi Ismaya Pebriani, Mala Pradana, Agrin Febrian Primadhani, Suci Widya Punniyakoti T. Veeraveedu Puspita Eka Wuyung Puspita Eka Wuyung Putri, Rizky Clarinta Radiana Dhewayani Antarianto Radoti Merlin Rani Hendiyani Rani Sauriasari Rani Sauriasari, Rani Rejeki, Marliana Sri Ria Anggraeni Rianto Setiabudy Rianto Setiabudy Riski Amanda, Clara Roro Rukmi Windi Perdani, Roro Rukmi ROS SUMARNY Ros Sumarny Safutra, Muhamad Sadam Safutra, Sadam Sagala, Radoti Merlin SEPTELIA INAWATI WANANDI Sesilia Keban Sesilia Keban, Sesilia Setyo Handryastuti Shimizu, Ippei Silmi Hanifah Soni Siswanto Sumiati, Yati Supraja Dwiyono Suyatna, Franciscus D Syarifah Dewi Thandavarayan, Rajarajan Amirthalingam Tri Yuliani Tri Yuliani, Tri Triana, Novi Tzeto Han Cong Ulfa T Wahyuni Ulya, Nurul Vetnizah Juniantito Vivian Soetikno Vivian Soetikno Wardani, Amanda Saphira Wikanendra, Gregorius Bhaskara Yati Sumiyati