Drug design, development and therapy · 2025
Efficacy and Safety of Clobazam Adjunctive Therapy in Pediatric Patients with Drug-Resistant Epilepsy.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Yu Lingyan, Chen Shunan, Zhang Zhou, Hu Yani, Fang Yuting, Mao Fengqian, Wang Suhong, Yu Zhenwei, Li Xuejuan, Dai Haibin
Аннотация
OBJECTIVE: To determine the efficacy and safety of clobazam, a benzodiazepine derivative endorsed for adjunctive therapy in drug-resistant epilepsy due to its broad-spectrum efficacy and tolerability profile, as an adjunctive treatment for pediatric patients with drug-resistant epilepsy.
METHODS: This was a multicenter, real-world, self-controlled study. Pediatric drug-resistant epilepsy patients receiving clobazam adjunctive treatment at three centers were retrospectively included. The primary outcomes were response rates and seizure-free rates at 6 and 12 months of treatment. The secondary outcomes included retention rates at months 6 and 12 of treatment and adverse events that occurred during the addition of clobazam therapy.
RESULTS: A total of 146 patients were included. The retention rates were 87.67% (128/146) and 81.51% (119/146) at 6 and 12 months, respectively. The response rates were 58.99% (82/139) and 62.41% (83/133), and the seizure-free rates were 36.69% (51/139) and 35.34% (47/133) at 6 and 12 month, respectively. Clobazam has shown good efficacy in patients with epilepsy due to genetic variants (60.42%, 29/48) and its significantly better efficacy for the SCN1A genotype than for other genotypes (P=0.048). The independent factor associated with clinical response was a lower baseline seizure frequency (seizure frequency <1 seizure/day). Adverse reactions occurred in 24 (24/146, 16.64%) patients, with excessive salivation/hypersalivation (4/146, 2.74%) and loss of appetite (4/146, 2.74%) being the most common.
CONCLUSION: Clobazam adjunctive therapy is effective, safe and well tolerated in pediatric patients with drug-resistant epilepsy.
METHODS: This was a multicenter, real-world, self-controlled study. Pediatric drug-resistant epilepsy patients receiving clobazam adjunctive treatment at three centers were retrospectively included. The primary outcomes were response rates and seizure-free rates at 6 and 12 months of treatment. The secondary outcomes included retention rates at months 6 and 12 of treatment and adverse events that occurred during the addition of clobazam therapy.
RESULTS: A total of 146 patients were included. The retention rates were 87.67% (128/146) and 81.51% (119/146) at 6 and 12 months, respectively. The response rates were 58.99% (82/139) and 62.41% (83/133), and the seizure-free rates were 36.69% (51/139) and 35.34% (47/133) at 6 and 12 month, respectively. Clobazam has shown good efficacy in patients with epilepsy due to genetic variants (60.42%, 29/48) and its significantly better efficacy for the SCN1A genotype than for other genotypes (P=0.048). The independent factor associated with clinical response was a lower baseline seizure frequency (seizure frequency <1 seizure/day). Adverse reactions occurred in 24 (24/146, 16.64%) patients, with excessive salivation/hypersalivation (4/146, 2.74%) and loss of appetite (4/146, 2.74%) being the most common.
CONCLUSION: Clobazam adjunctive therapy is effective, safe and well tolerated in pediatric patients with drug-resistant epilepsy.