Janssen Research & Development, LLC., Epidemiology, Titusville, New Jersey, USA.
Janssen Global Services, LLC., Global Market Access, Horsham, Pennsylvania, USA.
Epilepsia Open. 2022 Dec;7(4):598-607. doi: 10.1002/epi4.12632. Epub 2022 Aug 8.
The prevalence of epilepsy is slightly higher in women than in men and sensitivity to seizure stimuli differs between sexes. Some evidence suggests sex differences in response to antiseizure medications exist mainly due to inconsistent pharmacokinetic differences; however, there is a lack of real-world evidence examining differences in response to antiseizure medications between men and women.
This was a retrospective population-based cohort study in five large US healthcare databases. The population included adult patients with epilepsy, newly exposed to levetiracetam, and naive to antiseizure medication. The first exposure to levetiracetam was the index date. The requirement that all patients received the same medication was done to avoid potential confounding due to differences in index treatment. The outcome was the development of treatment resistant epilepsy (TRE), defined as having at least three distinct antiseizure medications in 1 year. The proportion of patients who developed TRE within 1 year following the index date was calculated. To compare the risk of developing TRE between sexes, relative risks (RR) and 95% confidence intervals (CI) were calculated, and estimates were pooled using meta-analytic techniques stratified by gender and age.
A total of 147 334 subjects were included in the databases, 50.8% were women, and 4.27% developed TRE. The comorbid profile differed greatly between men and women; however, the types of epilepsy syndromes observed during baseline were similar between the two groups. Across all databases, women were more likely to develop TRE than men (pooled RR 1.27, 95% CI 1.17-1.38). Results remained similar when stratified by age.
This study assessed sex differences in response to antiseizure medications using the development of TRE as a proxy for effectiveness. Women newly exposed to levetiracetam were 27% more likely to develop TRE than men, independent of age.
女性癫痫的患病率略高于男性，且男女对癫痫刺激的敏感性存在差异。有证据表明，抗癫痫药物的反应存在性别差异，主要归因于药代动力学的不一致；然而，缺乏真实世界的证据来检验男性和女性对抗癫痫药物反应的差异。
这是一项在美国五个大型医疗保健数据库中进行的回顾性基于人群的队列研究。该人群包括新开始使用左乙拉西坦且对抗癫痫药物无用药史的成年癫痫患者。首次使用左乙拉西坦的日期为索引日期。要求所有患者使用相同的药物，以避免由于索引治疗的差异而导致潜在的混杂。研究结果为耐药性癫痫（TRE）的发生，定义为在 1 年内至少使用了 3 种不同的抗癫痫药物。计算了从索引日期起 1 年内发生 TRE 的患者比例。为了比较男女之间发生 TRE 的风险，计算了相对风险（RR）和 95%置信区间（CI），并使用性别和年龄分层的荟萃分析技术对估计值进行了汇总。
从数据库中纳入了 147334 名患者，其中 50.8%为女性，4.27%发生了 TRE。男女的合并症特征差异很大；然而，两组在基线时观察到的癫痫综合征类型相似。在所有数据库中，女性发生 TRE 的风险均高于男性（汇总 RR 1.27，95% CI 1.17-1.38）。按年龄分层后结果仍然相似。
本研究使用耐药性癫痫的发生作为有效性的替代指标，评估了抗癫痫药物治疗中男女之间的差异。新开始使用左乙拉西坦的女性发生 TRE 的可能性比男性高 27%，与年龄无关。
