Rowan A J, Ramsay R E, Collins J F, Pryor F, Boardman K D, Uthman B M, Spitz M, Frederick T, Towne A, Carter G S, Marks W, Felicetta J, Tomyanovich M L
VA Medical Center, Bronx, NY 10468, USA.
Neurology. 2005 Jun 14;64(11):1868-73. doi: 10.1212/01.WNL.0000167384.68207.3E.
To determine the relative tolerability and efficacy of two newer antiepileptic drugs, lamotrigine (LTG) and gabapentin (GBP), as compared to carbamazepine (CBZ) in older patients with epilepsy.
This was an 18-center, randomized, double-blind, double dummy, parallel study of 593 elderly subjects with newly diagnosed seizures. Patients were randomly assigned to one of three treatment groups: GBP 1,500 mg/day, LTG 150 mg/day, CBZ 600 mg/day. The primary outcome measure was retention in trial for 12 months.
Mean age was 72 years. The most common etiology was cerebral infarction. Patients had multiple medical conditions and took an average of seven comedications. Mean plasma levels at 6 weeks were as follows: GBP 8.67 +/- 4.83 microg/mL, LTG 2.87 +/- 1.60 microg/mL, CBZ 6.79 +/- 2.92 microg/mL. They remained stable throughout the trial. Early terminations: LTG 44.2%, GBP 51%, CBZ 64.5% (p = 0.0002). Significant paired comparisons: LTG vs CBZ: p < 0.0001; GBP vs CBZ: p = 0.008. Terminations for adverse events: LTG 12.1%, GBP 21.6%, CBZ 31% (p = 0.001). Significant paired comparisons: LTG vs CBZ: p < 0.0001; LTG vs GBP: p = 0.015. There were no significant differences in seizure free rate at 12 months.
The main limiting factor in patient retention was adverse drug reactions. Patients taking lamotrigine (LTG) or gabapentin (GBP) did better than those taking carbamazepine. Seizure control was similar among groups. LTG and GBP should be considered as initial therapy for older patients with newly diagnosed seizures.
确定两种新型抗癫痫药物拉莫三嗪（LTG）和加巴喷丁（GBP）与卡马西平（CBZ）相比，在老年癫痫患者中的相对耐受性和疗效。
这是一项在18个中心进行的随机、双盲、双模拟、平行研究，共纳入593例新诊断癫痫发作的老年受试者。患者被随机分配到三个治疗组之一：GBP 1500毫克/天、LTG 150毫克/天、CBZ 600毫克/天。主要结局指标是试验持续12个月。
平均年龄为72岁。最常见的病因是脑梗死。患者有多种内科疾病，平均服用七种合并用药。6周时的平均血浆水平如下：GBP 8.67±4.83微克/毫升、LTG 2.87±1.60微克/毫升、CBZ 6.79±2.92微克/毫升。在整个试验过程中这些水平保持稳定。早期终止试验情况：LTG组为44.2%，GBP组为51%，CBZ组为64.5%（p = 0.0002）。显著的配对比较：LTG与CBZ：p < 0.0001；GBP与CBZ：p = 0.008。因不良事件终止试验情况：LTG组为12.1%，GBP组为21.6%，CBZ组为31%（p = 0.001）。显著的配对比较：LTG与CBZ：p < 0.0001；LTG与GBP：p = 0.015。12个月时无癫痫发作率无显著差异。
患者留存的主要限制因素是药物不良反应。服用拉莫三嗪（LTG）或加巴喷丁（GBP）的患者比服用卡马西平的患者情况更好。各治疗组间癫痫控制情况相似。LTG和GBP应被视为新诊断癫痫发作老年患者的初始治疗药物。
