Department of Neurology, The University of Arizona, 1501 N Campbell Ave., Tucson, AZ 85724, USA.
Neurology. 2010 May 18;74(20):1566-74. doi: 10.1212/WNL.0b013e3181df091b. Epub 2010 Apr 14.
To evaluate whether generic substitution was associated with any difference in medical resource utilization for 5 widely used antiepileptic drugs (AEDs) in the United States.
Health insurance claims from PharMetrics Database, representing over 90 health plans between January 2000 and October 2007, were analyzed. Adult patients with epilepsy, continuously treated with carbamazepine, gabapentin, phenytoin, primidone, or zonisamide, were selected. An open-cohort design was used to classify patients into mutually exclusive periods of brand vs generic use of AEDs. Pharmacy and medical utilization were compared between the 2 periods with multivariate regression analyses. Results were stratified into epilepsy-related medical services, and stable (< or = 2 outpatient visits per year and no emergency room visit) vs unstable epilepsy. Time-to-event analyses were also performed for all services and epilepsy-related endpoints.
A total of 18,125 patients were observed in the stable group and 15,500 patients in the unstable group. After adjustment of covariates, periods of generic AED treatment were associated with increased use of all prescription drugs (incidence rate ratio [IRR] [95% confidence interval (CI)] = 1.13 [1.13-1.14]) and higher epilepsy-related medical utilization rates (hospitalizations: IRR [95% CI] = 1.24 [1.19-1.30]; outpatient visits: IRR [95% CI] = 1.14 [1.13-1.16]; lengths of hospital stays: IRR [95% CI] = 1.29 [1.27-1.32]). Generic-use periods were associated with increased utilization rates in stable and unstable patients and with 20% increased risk of injury, compared to periods with brand use of AEDs.
Generic antiepileptic drug use was associated with significantly greater medical utilization and risk of epilepsy-related medical events, compared to brand use. This relationship was observed even in patients characterized as stable. AED = antiepileptic drug; CI = confidence interval; ER = emergency room; HR = hazard ratio; ICD = International Classification of Diseases; IRR = incidence rate ratio.
评估在美国,5 种广泛使用的抗癫痫药物(AED)的仿制药替代是否与医疗资源利用的任何差异有关。
分析 PharMetrics 数据库中的健康保险索赔数据,该数据库代表 2000 年 1 月至 2007 年 10 月期间的 90 多个健康计划。选择连续接受卡马西平、加巴喷丁、苯妥英、扑米酮或左乙拉西坦治疗的成年癫痫患者。使用开放式队列设计将患者分为 AED 品牌使用和仿制药使用的互斥期。使用多元回归分析比较 2 个时期的药房和医疗利用情况。结果按癫痫相关医疗服务以及稳定(每年门诊就诊次数≤2 次且无急诊就诊)和不稳定癫痫进行分层。还对所有服务和癫痫相关终点进行了时间事件分析。
在稳定组中观察到 18125 例患者,在不稳定组中观察到 15500 例患者。在调整协变量后,AED 仿制药治疗期与所有处方药的使用增加(发病率比 [IRR] [95%置信区间(CI)] = 1.13 [1.13-1.14])和癫痫相关医疗利用率的增加有关(住院治疗:IRR [95%CI] = 1.24 [1.19-1.30];门诊就诊:IRR [95%CI] = 1.14 [1.13-1.16];住院时间:IRR [95%CI] = 1.29 [1.27-1.32])。与使用 AED 品牌相比,仿制药使用期与稳定和不稳定患者的利用率增加以及癫痫相关医疗事件风险增加 20%相关。
与使用品牌 AED 相比,仿制药的使用与医疗利用率和癫痫相关医疗事件风险显著增加有关。即使在稳定的患者中也观察到这种关系。AED = 抗癫痫药物;CI = 置信区间;ER = 急诊室;HR = 风险比;ICD = 国际疾病分类;IRR = 发病率比。