Risk of angioedema associated with levetiracetam compared with phenytoin: Findings of the observational health data sciences and informatics research network.
Risk of angioedema associated with levetiracetam compared with phenytoin: Findings of the observational health data sciences and informatics research network.
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DOI：
10.1111/epi.13828
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发表时间：
2017-08
期刊：
影响因子：
5.6
通讯作者：
Schuemie MJ
中科院分区：
文献类型：
--
作者：
Duke JD;Ryan PB;Suchard MA;Hripcsak G;Jin P;Reich C;Schwalm MS;Khoma Y;Wu Y;Xu H;Shah NH;Banda JM;Schuemie MJ
最近的不良事件报告提出了与左乙拉西坦暴露相关的血管性水肿风险增加的问题。为了帮助解决这个问题，观察健康数据科学和信息学研究网络对 10 个数据库中暴露于左乙拉西坦的癫痫患者 (n = 276,665) 进行了一项回顾性观察性新用户队列研究。以苯妥英使用者（n = 74,682）作为比较组，进行倾向评分匹配，并通过按方案和意向治疗分析计算血管水肿事件的风险比。左乙拉西坦组和苯妥英组均很少发生血管性水肿事件（符合方案组为 54 例 vs 71 例，意向治疗组为 248 例 vs 435 例）。在任何个体数据库中均未发现左乙拉西坦导致血管性水肿风险显着增加（风险比范围为 0.43 至 1.31）。荟萃分析显示，按方案分析和意向治疗分析的总结风险比分别为 0.72（95% 置信区间 [CI] 0.39-1.31）和 0.64（95% CI 0.52-0.79）。结果表明，左乙拉西坦的血管性水肿风险与苯妥英相同或更低，苯妥英目前没有针对血管性水肿的标签警告。需要进一步研究来评估所有抗癫痫药物的血管性水肿风险。
Recent adverse event reports have raised the question of increased angioedema risk associated with exposure to levetiracetam. To help address this question, the Observational Health Data Sciences and Informatics research network conducted a retrospective observational new-user cohort study of seizure patients exposed to levetiracetam (n = 276,665) across 10 databases. With phenytoin users (n = 74,682) as a comparator group, propensity score-matching was conducted and hazard ratios computed for angioedema events by per-protocol and intent-to-treat analyses. Angioedema events were rare in both the levetiracetam and phenytoin groups (54 vs. 71 in per-protocol and 248 vs. 435 in intent-to-treat). No significant increase in angioedema risk with levetiracetam was seen in any individual database (hazard ratios ranging from 0.43 to 1.31). Meta-analysis showed a summary hazard ratio of 0.72 (95% confidence interval [CI] 0.39–1.31) and 0.64 (95% CI 0.52–0.79) for the per-protocol and intent-to-treat analyses, respectively. The results suggest that levetiracetam has the same or lower risk for angioedema than phenytoin, which does not currently carry a labeled warning for angioedema. Further studies are warranted to evaluate angioedema risk across all antiepileptic drugs.
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影响因子：
2
作者：
Schuemie, Martijn J.;Ryan, Patrick B.;DuMouchel, William;Suchard, Marc A.;Madigan, David
通讯作者：
Madigan, David
DOI：
10.1145/2414416.2414791
发表时间：
2013-01
期刊：
ACM transactions on modeling and computer simulation : a publication of the Association for Computing Machinery
影响因子：
--
作者：
Suchard MA;Simpson SE;Zorych I;Ryan P;Madigan D
通讯作者：
Madigan D
DOI：
10.1097/ede.0000000000000504
发表时间：
2016-09
期刊：
Epidemiology (Cambridge, Mass.)
影响因子：
--
作者：
Arnold BF;Ercumen A;Benjamin-Chung J;Colford JM Jr
通讯作者：
Colford JM Jr
影响因子：
3.7
作者：
Böhm R;von Hehn L;Herdegen T;Klein HJ;Bruhn O;Petri H;Höcker J
通讯作者：
Höcker J
影响因子：
2.6
作者：
Rassen, Jeremy A.;Shelat, Abhi A.;Schneeweiss, Sebastian
通讯作者：
Schneeweiss, Sebastian