Quality-of-life outcomes of initiating treatment with standard and newer antiepileptic drugs in adults with new-onset epilepsy: Findings from the SANAD trial

Quality-of-life outcomes of initiating treatment with standard and newer antiepileptic drugs in adults with new-onset epilepsy: Findings from the SANAD trial
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DOI:
10.1111/epi.12913
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发表时间:
2015-03-01
期刊:
影响因子:
5.6
通讯作者:
Baker, Gus A.
Baker, Gus A.
中科院分区:
医学1区
文献类型:
--
作者:
Jacoby, Ann;Sudell, Maria;Baker, Gus A.

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目的:比较新发癫痫成人患者开始使用标准或更新抗癫痫药物(AED)治疗后2年内的生活质量(QoL)结局。研究癫痫发作缓解和初始治疗失败对2年内测量的生活质量结果的影响。我们进行了一项务实、随机、非盲、多中心、平行组临床试验(标准和新型抗癫痫药物[SANAD]试验)比较了卡马西平与拉莫三嗪、加巴喷丁、奥卡西平和托吡酯的临床和成本效益,和丙戊酸盐对比拉莫三嗪和托吡酯。使用经验证的测量方法,通过邮件收集基线、3个月、1年和2年的生活质量数据。使用纵向数据模型分析这些数据。连续生活质量的措施,时间到12个月的缓解和治疗退出的时间进行了探讨,使用联合models.Results:基线问卷调查返回的1,575名成年人,1,439返回3个月的问卷,1,274返回1年的问卷,1,121返回2年的问卷。两种药物在2年内的QoL结果几乎没有统计学显著差异。显着的关联被确定在2年的时间框架和经历了12个月的缓解或治疗退出在此期间的风险之间的生活质量评分。意义:初始治疗的选择没有显着影响生活质量的2年随访。然而,总体生活质量随着持续癫痫发作、不良事件和初始治疗失败而降低。
Objective: To compare quality-of-life (QoL) outcomes over 2 years following initiation of treatment with a standard or newer antiepileptic drug (AED) in adults with new-onset epilepsy. To examine the impact of seizure remission and failure of initial treatment on QoL outcomes measured over 2 years.Methods: We conducted a pragmatic, randomized, unblinded, multicenter, parallel-group clinical trial (the Standard and New Antiepileptic Drugs [SANAD] trial) comparing clinical and cost effectiveness of initiating treatment with carbamazepine versus lamotrigine, gabapentin, oxcarbazepine and topiramate, and valproate versus lamotrigine and topiramate. QoL data were collected by mail at baseline, 3 months, and at 1 and 2 years using validated measures. These data were analyzed using longitudinal data models. Continuous QoL measures, time to 12-month remission and time to treatment withdrawal were explored using joint models.Results: Baseline questionnaires were returned by 1,575 adults; 1,439 returned the 3-month questionnaire, 1,274 returned the 1-year questionnaire, and 1,121 returned the 2-year questionnaire. There were few statistically significant differences between drugs over 2 years in QoL outcomes. Significant association was identified between QoL scores over the 2-year time frame and the risk of experiencing a 12-month remission or treatment withdrawal over that period.Significance: The choice of initial treatment had no significant effect on QoL by 2-year follow-up. However, overall QoL was reduced with continued seizures, adverse events, and failure of the initial treatment.