Giorgi L, Gomez G, O'Neill F, Hammer A E, Risner M
Glaxo Wellcome plc, Greenford, Middlesex, United Kingdom.
Drugs Aging. 2001;18(8):621-30. doi: 10.2165/00002512-200118080-00006.
To determine the tolerability of lamotrigine in elderly patients with epilepsy.
Pooled data from 13 lamotrigine clinical trials.
Multicentre clinical trials conducted in primary care and neurology practices.
208 elderly patients (aged > or = 65 years) were identified: 146 lamotrigine-treated patients, 53 carbamazepine-treated patients and 9 phenytoin-treated patients.
Extent of exposure, incidence of drug-related adverse events, serious adverse events and study withdrawals were examined.
The median duration of exposure for lamotrigine monotherapy and add-on therapy was 24.1 and 47.4 weeks, respectively. The median daily dosage of lamotrigine was 100 mg for monotherapy (range 75 to 500 mg) and 300 mg for add-on therapy (range 25 to 700 mg). Overall, the incidence of drug-related adverse events was lower for lamotrigine than comparator drugs: 49% (72/146) for lamotrigine compared with 72% (38/53) for carbamazepine (p = 0.006), and 89% (8/9) for phenytoin (p = 0.035) although patient numbers in each treatment group were not comparable. Patients receiving lamotrigine reported incidences of somnolence (p = 0.012), rash (p = 0.034), and headache (nonsignificant) that were one-half the incidence reported with carbamazepine monotherapy. Rash was the most common reason for study withdrawal: 4% (6/146) lamotrigine, 17% (9/53) carbamazepine and 0% phenytoin. Seven (5%, 7/146) lamotrigine-treated patients, 4 (8%, 4/53) carbamazepine-treated patients and 1 (11%, 1/9) phenytoin-treated patient experienced drug-related serious adverse events.
Lamotrigine, used in the currently prescribed adult dosage regimen, was well tolerated in elderly patients with epilepsy.
确定拉莫三嗪在老年癫痫患者中的耐受性。
来自13项拉莫三嗪临床试验的汇总数据。
在初级保健和神经科诊所进行的多中心临床试验。
确定了208例老年患者（年龄≥65岁）：146例接受拉莫三嗪治疗的患者、53例接受卡马西平治疗的患者和9例接受苯妥英治疗的患者。
检查暴露程度、药物相关不良事件的发生率、严重不良事件和研究退出情况。
拉莫三嗪单药治疗和联合治疗的中位暴露持续时间分别为24.1周和47.4周。拉莫三嗪单药治疗的中位日剂量为100mg（范围75至500mg），联合治疗为300mg（范围25至700mg）。总体而言，拉莫三嗪药物相关不良事件的发生率低于对照药物：拉莫三嗪为49%（72/146），卡马西平为72%（38/53）（p = 0.006），苯妥英为89%（8/9）（p = 0.035），尽管各治疗组的患者数量不具可比性。接受拉莫三嗪治疗的患者报告的嗜睡发生率（p = 0.012）、皮疹发生率（p = 0.034）和头痛发生率（无显著性差异）是卡马西平单药治疗报告发生率的一半。皮疹是研究退出的最常见原因：拉莫三嗪为4%（6/146），卡马西平为17%（9/53），苯妥英为0%。7例（5%，7/146）接受拉莫三嗪治疗的患者、4例（8%，4/53）接受卡马西平治疗的患者和1例（11%，1/9）接受苯妥英治疗的患者发生了药物相关严重不良事件。
以目前规定的成人剂量方案使用的拉莫三嗪在老年癫痫患者中耐受性良好。
