Comparative monotherapy trials and the clinical treatment of epilepsy.
Comparative monotherapy trials and the clinical treatment of epilepsy.
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DOI：
10.1111/j.1535-7511.2007.00198.x
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发表时间：
2007-09-01
影响因子：
3.6
通讯作者：
Abou-Khalil, Bassel W
中科院分区：
文献类型：
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作者：
Abou-Khalil, Bassel W
左乙拉西坦与卡马西平控释片在新诊断癫痫中的比较.Brodie MJ，Perucca E，Ryvlin P，Ben-Menachem E，Meencke HJ;左乙拉西坦单药治疗研究组.神经病学2007;68（6）：402- 408.左乙拉西坦是一种具有独特作用机制的新型抗癫痫药物，与首次治疗新诊断癫痫的卡马西平控释片进行比较。在一项多中心、双盲、非劣效性、平行组试验中，将前一年阵挛性癫痫发作的患者随机分配至左乙拉西坦（500 mg，每日两次，n= 288）或控释卡马西平（200 mg，每日两次，n= 291）组。如果在稳定后26周内发生癫痫发作，则剂量递增至最大左乙拉西坦1,500 mg每日2次或卡马西平600 mg每日2次。达到主要终点的患者（6个月无癫痫发作）继续治疗6个月的维持期。（56.6%）随机分配至左乙拉西坦组的患者和72.8%（58.5%）接受控释卡马西平的患者在末次评价剂量时无癫痫发作（校正绝对差异0.2%，95% CI - 7.8%至8.2%）持续6个月（1年）。在所有达到6个月（1年）缓解的患者中，左乙拉西坦组80.1%（86.0%）和卡马西平组85.4%（89.3%）在最低剂量水平达到缓解。不良事件的退出率分别为14.4%与左乙拉西坦和19.2%with carbamazepine.CONCLUSIONSLevetiracetam和控释卡马西平在新诊断的癫痫在最佳剂量在模拟临床实践的设置相等的癫痫发作自由率。这项试验在一个随机、双盲的环境中证实了以前未对照的观察结果，即大多数癫痫患者对他们的第一种低剂量抗癫痫药物有反应。
Comparison of Levetiracetam and Controlled-Release Carbamazepine in Newly Diagnosed Epilepsy.Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke HJ; Levetiracetam Monotherapy Study Group.Neurology2007;68(6):402–408.OBJECTIVEWe report the results of a prospective study of the efficacy and tolerability of levetiracetam, a new antiepileptic drug witha unique mechanism of action, in comparison with controlled-release carbamazepine as first treatment in newly diagnosed epilepsy.METHODSAdults with 2 partial or generalized tonic–clonic seizures in the previous year were randomly assigned to levetiracetam (500 mg twice daily,n= 288) or controlled-release carbamazepine (200 mg twice daily,n= 291) in a multicenter, double-blind, noninferiority, parallel-group trial. If a seizure occurred within 26 weeks of stabilization, dosage was increased incrementally to a maximum of levetiracetam 1,500 mg twice daily or carbamazepine 600 mg twice daily. Patients achieving the primary endpoint (6-month seizure freedom) continued on treatment for a further 6-month maintenance period.RESULTSAt per-protocol analysis, 73.0% (56.6%) of patients randomized to levetiracetam and 72.8% (58.5%) receiving controlled-release carbamazepine were seizure free at the last evaluated dose (adjusted absolute difference 0.2%, 95% CI – 7.8% to 8.2%) for 6 months (1 year). Of all patients achieving 6-month (1-year) remission, 80.1% (86.0%) in the levetiracetam group and 85.4% (89.3%) in the carbamazepine group did so at the lowest dose level. Withdrawal rates for adverse events were 14.4% with levetiracetam and 19.2% with carbamazepine.CONCLUSIONSLevetiracetam and controlled-release carbamazepine produced equivalent seizure freedom rates in newly diagnosed epilepsy at optimal dosing in a setting mimicking clinical practice. This trial has confirmed in a randomized, double-blind setting previously uncontrolled observations that most people with epilepsy will respond to their first-ever antiepileptic drug at low dosage.