Department of Epileptology, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.
Department of Pharmaceutical Sciences, Tohoku University Hospital, Sendai, Miyagi, Japan; Environment and Genome Research Center, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan; Tohoku Medical Megabank Organization, Tohoku University, Sendai, Miyagi, Japan.
Epilepsy Behav. 2022 Sep;134:108841. doi: 10.1016/j.yebeh.2022.108841. Epub 2022 Jul 25.
To investigate whether newer anti-seizure medications (ASMs) are widely prescribed for a range of adult patients in Japan, including patients with previously and newly diagnosed epilepsy, or with focal and generalized epilepsies.
A retrospective cohort study was conducted using the Japanese insurance claims database including 8.4 million people to identify adults (≥16 years of age) with epilepsy diagnosis code identified between January 2015 and December 2018. Patients were included in the prevalent population if epilepsy was already diagnosed at baseline, and in the incident population if prior baseline data for at least 12 months included no epilepsy diagnosis code or ASM prescription. Patients were followed up from the month when the initial oral ASM was prescribed for up to 4 years until the end of 2019 as long as at least one ASM was prescribed. Proportions of prescribed oral ASMs were analyzed by population with epilepsy (prevalent vs. incident) and classification (focal vs. generalized). Anti-seizure medications were classified into older vs. newer ASMs according to the date of approval before and after 1990, respectively.
A total of 24,691 patients fulfilled the eligibility criteria for the analysis. Of these, 21,046 and 3,645 were included in the prevalent and incident populations, respectively. The proportion of older ASMs significantly decreased, whereas the proportion of newer ASMs significantly increased (p < 0.0001) during the study period. This trend was more apparent in the population with incident epilepsy than in that with prevalent epilepsy, and was also apparent in the subgroup of focal epilepsy, but not in that of generalized epilepsy. Levetiracetam was the most frequently prescribed of the newer ASMs.
Newer ASMs became more widely prescribed throughout the study period in populations with both prevalent and incident epilepsies, as well as the subpopulation with focal epilepsy. The advantages of newer ASMs such as better safety profiles may have led to the increasing proportions of prescriptions and newer ASMs may increase the treatment options for patients.
调查在日本，新型抗癫痫药物（ASM）是否广泛用于多种成年患者，包括既往和新诊断的癫痫患者，或局灶性和全面性癫痫患者。
本研究采用回顾性队列研究，使用日本保险索赔数据库，纳入 840 万人，识别出 2015 年 1 月至 2018 年 12 月期间诊断为癫痫的成年人（≥16 岁）。如果基线时已经诊断出癫痫，则患者被纳入现患人群；如果基线期至少有 12 个月的数据中没有癫痫诊断代码或 ASM 处方，则患者被纳入新发人群。从初始口服 ASM 处方的月份开始，患者接受随访，最长随访 4 年，直至 2019 年底，只要至少开具了一种 ASM 处方。通过现患人群（现患 vs. 新发）和分类（局灶性 vs. 全面性）分析处方口服 ASM 的比例。根据批准日期（1990 年之前和之后），将抗癫痫药物分为旧 ASM 和新 ASM。
共有 24691 名患者符合分析条件。其中，21046 名和 3645 名患者分别纳入现患人群和新发人群。在研究期间，旧 ASM 的比例显著下降，而新 ASM 的比例显著增加（p<0.0001）。与现患癫痫患者相比，新发癫痫患者中这一趋势更为明显，局灶性癫痫亚组中也有此趋势，但全面性癫痫亚组中没有。左乙拉西坦是新 ASM 中最常开的药物。
在现患和新发癫痫患者人群以及局灶性癫痫亚组中，新型 ASM 在整个研究期间的应用越来越广泛。新型 ASM 具有更好的安全性等优势，可能导致处方比例增加，也可能为患者提供更多的治疗选择。
