Express-Scripts, Inc., One Express Way, St Louis, MO 63121, USA.
Curr Med Res Opin. 2010 Feb;26(2):455-63. doi: 10.1185/03007990903488704.
Concerns have been raised over the use of different manufacturers' versions of A-rated antiepileptic drug (AED) formulations in epilepsy patients.
To estimate the association between acute epilepsy exacerbations and switching between different A-rated AEDs.
A nested case-control study was conducted using pharmacy and medical claims data from January 1, 2005 through December 31, 2007. 18-65-year-olds who had an epilepsy diagnosis and received AED therapy during 2005 were eligible for study. Cases were defined as individuals with a documented exacerbation of epilepsy in the form of a 2006 or 2007 inpatient or emergency room claim for epilepsy. Controls were from the same population and matched on baseline epilepsy diagnosis and follow-up time since January 1, 2006. The exposure was a switch between A-rated AEDs in the 90 days prior to the matching date. Conditional logistic regression was used to estimate the odds of an epilepsy exacerbation after a switch controlling for important covariates.
A total of 34 216 individuals were eligible for study, of whom 2949 cases were matched to 8847 controls. The unadjusted odds ratio (OR) between a switch and an epilepsy exacerbation was 1.51 (95% CI: 1.29-1.76). After adjusting for potential confounders, the odds ratio was 1.08 (95% CI: 0.91-1.29). Treatment with three or more AEDs or a change in outpatient diagnosis from baseline resulted in ORs of 2.96 (95% CI: 2.48-3.49) and 2.53 (95% CI: 2.28-2.82), respectively.
After addressing potential confounders, no evidence that A-rated switching was associated with increased acute exacerbations of epilepsy was found. Study limitations include potentially incomplete identification of seizures, no information on indication for medication use, and limited information on duration and severity of disease. This study provides additional insight into the relationship between A-rated AED switching and acute exacerbations of epilepsy.
人们对癫痫患者使用不同制造商的 A 级抗癫痫药物 (AED) 制剂提出了担忧。
评估癫痫发作加剧与不同 A 级 AED 之间转换的关联。
使用 2005 年 1 月 1 日至 2007 年 12 月 31 日的药房和医疗索赔数据进行嵌套病例对照研究。2005 年有癫痫诊断并接受 AED 治疗的 18-65 岁患者符合研究条件。病例定义为 2006 年或 2007 年癫痫住院或急诊就诊记录癫痫发作加剧的患者。对照来自同一人群,并根据基线癫痫诊断和自 2006 年 1 月 1 日起的随访时间进行匹配。暴露是在匹配日期前 90 天内 A 级 AED 之间的转换。使用条件逻辑回归估计转换后癫痫发作加剧的可能性,同时控制重要协变量。
共有 34216 名患者符合研究条件,其中 2949 例病例与 8847 例对照相匹配。调整潜在混杂因素后,转换与癫痫发作加剧之间的比值比 (OR) 为 1.08 (95% CI:0.91-1.29)。使用三种或更多种 AED 治疗或门诊诊断从基线发生变化,其比值比分别为 2.96 (95% CI:2.48-3.49) 和 2.53 (95% CI:2.28-2.82)。
在解决潜在混杂因素后,没有证据表明 A 级转换与癫痫急性发作加剧相关。研究局限性包括可能未完全识别癫痫发作、药物使用指征的信息、疾病持续时间和严重程度的信息有限。本研究提供了关于 A 级 AED 转换与癫痫急性发作加剧之间关系的更多见解。