Ting Zhao1, Hong-Jian Li1, Long Ma2, Jie Feng1, Ting-Ting Wang1, Jing Yu2, Li Sun1, Yan Sun3, Lu-Hai Yu4. 1. Department of Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China; Institute of Clinical Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China. 2. Department of Neurology, Children's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China. 3. Department of Neurology, Children's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China. Electronic address: sunkefang@163.com. 4. Department of Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China; Institute of Clinical Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China. Electronic address: 1523264450@qq.com.
Abstract
PURPOSE: Lacosamide (LCM) was approved in China in 2018. However, the safety of LCM has not been established in pediatric patients. Therefore, the objective of this study was to investigate its safety, efficacy, and tolerability in pediatric patients living in Uygur, Northwest China. METHODS: This is a retrospective analysis of pediatric patients diagnosed with epilepsy and on LCM therapy at a medical center. The seizure frequencies at 3, 6, and 12 months after starting LCM therapy were recorded and compared with the baseline monthly frequency. The primary outcome variables were the 50% responder and seizure-free rates. The secondary outcome variables included the terminal 6-month seizure remission and percentages of discontinuation due to a lack of efficacy and tolerability. Safety variables included the incidence and type of adverse reactions. RESULTS: Seventy-two pediatric patients with epilepsy living in Uygur, China and receiving LCM treatment were included in the present study. Fifty (69%) children responded to LCM therapy with a more than 50% reduction in the frequency of seizures. Seizure-free rates increased over time, at 14%, 19%, and 20% at 3, 6, and 12 months, respectively. The number of baseline anti-seizure medications (ASMs) and order of LCM introduction significantly impacted the likelihood of seizure remission during the 12-month follow-up period (p < 0.05). During the entire period of LCM treatment, twenty-two children (30.5%) experienced at least one adverse reaction. CONCLUSION: This retrospective study of 72 pediatric patients with epilepsy in Uygur, China, showed that LCM therapy is safe and effective for epilepsy in children, resulting in a reduction in the seizure rate.
PURPOSE:Lacosamide (LCM) was approved in China in 2018. However, the safety of LCM has not been established in pediatric patients. Therefore, the objective of this study was to investigate its safety, efficacy, and tolerability in pediatric patients living in Uygur, Northwest China. METHODS: This is a retrospective analysis of pediatric patients diagnosed with epilepsy and on LCM therapy at a medical center. The seizure frequencies at 3, 6, and 12 months after starting LCM therapy were recorded and compared with the baseline monthly frequency. The primary outcome variables were the 50% responder and seizure-free rates. The secondary outcome variables included the terminal 6-month seizure remission and percentages of discontinuation due to a lack of efficacy and tolerability. Safety variables included the incidence and type of adverse reactions. RESULTS: Seventy-two pediatric patients with epilepsy living in Uygur, China and receiving LCM treatment were included in the present study. Fifty (69%) children responded to LCM therapy with a more than 50% reduction in the frequency of seizures. Seizure-free rates increased over time, at 14%, 19%, and 20% at 3, 6, and 12 months, respectively. The number of baseline anti-seizure medications (ASMs) and order of LCM introduction significantly impacted the likelihood of seizure remission during the 12-month follow-up period (p < 0.05). During the entire period of LCM treatment, twenty-two children (30.5%) experienced at least one adverse reaction. CONCLUSION: This retrospective study of 72 pediatric patients with epilepsy in Uygur, China, showed that LCM therapy is safe and effective for epilepsy in children, resulting in a reduction in the seizure rate.
Authors: Ting Zhao; Hong-Jian Li; Jie Feng; Hui-Lan Zhang; Wang Ting-Ting; Long Ma; Jing Yu; Wen-Bo Zhao; Li Sun; Lu-Hai Yu; Yan Sun Journal: Ther Drug Monit Date: 2021-10-05 Impact factor: 3.118