Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts.
Department of Neurology, Harvard Medical School, Boston, Massachusetts.
Pharmacoepidemiol Drug Saf. 2021 Jan;30(1):28-36. doi: 10.1002/pds.5139. Epub 2020 Oct 2.
To examine indications for, duration of use, and rate of adverse drug events (ADE) attributable to anticonvulsant initiation, as adjudicated by expert review of electronic health records (EHR) of older adults.
We identified a cohort of community dwelling Medicare beneficiaries with linked EHR (aged 65+, continuously enrolled with a large health system/until death between 2012 and 2014, n = 20 945) and drew a stratified EHR review sample (n = 1534). An expert reviewed all records to adjudicate anticonvulsant use, years of use, indication for use, and evidence of ADEs attributable to anticonvulsant initiation. After excluding patients with insufficient EHR data (n = 37; 2%), we reconstructed the cohort using inverse probability weights to resemble the original cohort of eligible beneficiaries (n = 20 380). Among incident users of a single anticonvulsant, we estimated the rate of ADEs and described the type and severity of ADEs.
Overall, 12% (n = 2469) of eligible beneficiaries used at least one anticonvulsant in the 2012 to 2014 period (4% [n = 757] incident users, 8% [n = 1712] prevalent users). Incident users were most frequently prescribed gabapentin (n = 461/757, 61%), benzodiazepines (n = 122/757, 16%), and levetiracetam (n = 74/757, 10%); the most common indication was pain relief (n = 214; 28%) followed by epilepsy (n = 53; 7%). Among incident users, the overall ADE rate was 10/100 person-years (95% CI 4-20/100 person-years), of which 29% (n = 28/97) were life threatening (eg, somnolence). Most ADEs among incident monotherapy users were nervous system related (68%, n = 66/97).
Many older adult community dwelling traditional Medicare beneficiaries had clinically significant ADEs likely attributable to the initiation of anticonvulsant therapy, which was begun for a range of indications.
通过对老年人电子健康记录（EHR）的专家审查，研究抗惊厥药物起始使用的适应证、使用时间和不良反应事件（ADE）的发生率。
我们确定了一个由社区居住的 Medicare 受益人群组成的队列，这些人都有相关的 EHR（年龄在 65 岁及以上，在大型医疗系统中持续参保/直至 2012 年至 2014 年期间死亡，n=20945），并抽取了分层 EHR 审查样本（n=1534）。一位专家对所有记录进行了审查，以确定抗惊厥药物的使用、使用年限、使用指征以及因抗惊厥药物起始治疗而产生的 ADE 证据。在排除 EHR 数据不足的患者（n=37；2%）后，我们使用逆概率权重对队列进行了重建，使其与符合条件的受益人群（n=20380）相似。在单种抗惊厥药物的新使用者中，我们估计了 ADE 的发生率，并描述了 ADE 的类型和严重程度。
在 2012 年至 2014 年期间，共有 12%（n=2469）的合格受益人群至少使用了一种抗惊厥药物（4%[n=757]为新使用者，8%[n=1712]为现用者）。新使用者最常被开的药物为加巴喷丁（n=461/757，61%）、苯二氮䓬类（n=122/757，16%）和左乙拉西坦（n=74/757，10%）；最常见的指征是缓解疼痛（n=214；28%），其次是癫痫（n=53；7%）。在新使用者中，总的 ADE 发生率为 10/100 人年（95%CI，4-20/100 人年），其中 29%（n=28/97）为危及生命的（如嗜睡）。在新用单药治疗的患者中，大多数 ADE 与神经系统有关（68%，n=66/97）。
许多社区居住的传统 Medicare 受益的老年人群有临床意义重大的 ADE，可能与抗惊厥药物治疗的开始有关，这些药物开始用于多种指征。
