Effectiveness and safety of clobazam as add-on therapy in children after the failure of first antiseizure medicine: a sub-analysis of the ADD-ON study.
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Satishchandra Parthasarathy, Rathore Chaturbhuj, Kumar Abhishek, Apte Anirudha, Mandal Amlan, Menon Bindu, Chauhan Dushyant, Agadi Jagadish, Gurumukhani Jayanti, Asokan K, Ramadoss K, Venkateshwarlu K, Lingappa Lokesh, Malokar Monika, Sundaracharya Nagarjunakonda Venkata, Ghosh Pahari, Gupta Praveen, Ravat Sangeeta, Vk Sanjeev, Garg Siddhartha, Jha Sudhir K, Shah Sudhir Vadilal, Alagesan Sundaram, Razdan Sushil, Padhy Uma, Agarwal Vinay Kumar, Arora Vinod, Gadekar Arvind, Ahmed Afnan, Gandhi Kedar, Chodankar Deepa, Chinchansurkar Sunny, Arivazhahan Avinash, Menon Shalini, Telang Nivedita
Аннотация
METHODS: This was a subset analysis of the ADD-ON study (a prospective, multicentre, real-world, observational study of adding clobazam after the failure of first monotherapy) in children <18 years, conducted at 28 neurology outpatient clinics in India. Data pertaining to children with epilepsy aged <18 years in the ADD-ON study were evaluated. Seizure freedom rates at 1, 3, 6, 9, and 12 months after starting CLB were analyzed. Seizure diaries and personal interviews were used to assess seizure control and side effects.
RESULTS: Of the 475 eligible participants from the ADD-ON study, 107 (22.5%) children were included. The median age was 13.0 (range, 3-17) years and 62.6% were boys. The median epilepsy duration was 2.0 years (range, 0.1-16). Majority of the children (n=43, 40.2%) had tonic-clonic seizures. The major reason for adding CLB to the existing therapy was inadequate control of seizures with current treatment (n=105, 98.1%). Of the 107 children, 92 completed one year of follow-up and were receiving CLB (retention rate: 85.9%) and at one-year, 74 (69.2%) children were seizure-free. Seizure freedom rates were similar for all seizure types. No major adverse effects related to clobazam were recorded during the study period.
CONCLUSION: This subanalysis of the ADD-ON study suggests that clobazam is effective and well-tolerated as an add-on therapy for children after the failure of the first ASM monotherapy. Our preliminary results from this one-year follow-up study need to be substantiated by randomized controlled studies.
TRIAL REGISTRATION NUMBER: CTRI/2017/12/010906.